Safety, Tolerability, Pharmacokinetics and Target Engagem... | NCT05174013 | Trialant
NCT05174013
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
May 15, 2025Actual
Enrollment
33Actual
Phase
Phase 1
Conditions
Pain
Interventions
GSK3858279
Placebo
Countries
Australia
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT05174013
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
212979
Secondary IDs
Not provided
Brief Title
Safety, Tolerability, Pharmacokinetics and Target Engagement of GSK3858279 in Healthy Caucasian, Chinese and Japanese Participants
Official Title
A Randomised, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, Target Engagement and Immunogenicity of a Single Subcutaneous Dose of GSK3858279 Administered to Healthy Caucasian, Chinese and Japanese Participants
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
May 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 14, 2022Actual
Primary Completion Date
Feb 10, 2023Actual
Completion Date
Apr 17, 2023Actual
First Submitted Date
Dec 22, 2021
First Submission Date that Met QC Criteria
Dec 22, 2021
First Posted Date
Dec 30, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Jan 31, 2025
Results First Submitted that Met QC Criteria
May 14, 2025
Results First Posted Date
May 15, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 14, 2025
Last Update Posted Date
May 15, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), target engagement (TE) and immunogenicity of GSK3858279 when administered to healthy Caucasian, Chinese and Japanese participants.
Detailed Description
Not provided
Conditions Module
Conditions
Pain
Keywords
Pharmacokinetics
Safety
Tolerability
GSK3858279
Placebo
Caucasian
Chinese
Japanese
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
33Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
GSK3858279 Caucasian
Experimental
Participants received 240 milligrams (mg) of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.
Drug: GSK3858279
GSK3858279 Chinese
Experimental
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.
Drug: GSK3858279
GSK3858279 Japanese
Experimental
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.
Drug: GSK3858279
Caucasian Placebo
Placebo Comparator
Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.
Drug: Placebo
Chinese Placebo
Placebo Comparator
Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.
Drug: Placebo
Japanese Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
GSK3858279
Drug
GSK3858279 will be administered
GSK3858279 Caucasian
GSK3858279 Chinese
GSK3858279 Japanese
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAE's) And Withdrawals Due to AE's
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAEs are defined as any untoward medical occurrence that, at any dose: results in death, cause life threatening events which requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability or incapacity and birth defect or congenital anomaly. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169.
Up to 169 days
Change From Baseline in Hematology Parameter of Platelet Count
Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Baseline and Day 169
Change From Baseline in Hematology Parameter of Hemoglobin
Blood samples were collected for the assessment of change from baseline in hematology parameters Hemoglobin. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Baseline and Day 169
Change From Baseline in Hematology Parameter of Hematocrit
Blood samples were collected for the assessment of change from baseline in hematology parameters Hematocrit. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Secondary Outcomes
Measure
Description
Time Frame
Percentage Change From Baseline in Free CCL17
Blood samples were collected from participants at time points after the administration of study treatment to investigate PK parameters. The study intervention dose was administered on Study Day 1(baseline), where 7 days post-dose totals to Study Day 1+7days = Study Day 8. Following results of Day 8, Day 15, Day 29 and Day 57 corelates to timepoints Day 7, Day 14, Day 28 and Day 56 post dose values and same are presented here.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participants between 20 and 65 years of age inclusive, at the time of signing the informed consent.
Volunteers who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
Participant capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Participants who have evidence of completed vaccination for Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) with an approved vaccine.
Body weight within the range 45 - 100 killogram (kg) and body mass index (BMI) within the range 18-29.9 kg per meter square (/m2) (inclusive).
Japanese participants are eligible based on meeting all of the following:
Participants born in Japan
Descendants of four ethnic Japanese grandparents and two ethnic Japanese parents.
Have lived outside Japan for less than (<) 10 years at the time of screening
Chinese participants are eligible based on meeting all of the following
Participants born in mainland China, Hong Kong or Taiwan
Descendants of four Chinese grandparents and two Chinese parents
Have lived outside China, Hong Kong or Taiwan for <10 years at the time of screening
Caucasian participants are eligible based on meeting the following
Declaration of familial Caucasian/European ancestry (having 2 parents of Caucasian/European ancestry and 4 grandparents of Caucasian/European ancestry)
Male or female participant
Male participants are eligible to participate if they agree to the following for at least 28 weeks after the dose of study intervention: Refrain from donating sperm plus either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR must agree to use contraception/barrier as detailed below: agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a woman of childbearing potential who is not currently pregnant.
A female participant is eligible to participate if she is of non-reproductive potential.
Capable of giving signed informed consent.
Exclusion Criteria:
History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, haematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
Personal or family history of cardiomyopathy.
Abnormal blood pressure at screening as determined by the investigator.
History of symptomatic herpes zoster.
Evidence of active or latent tuberculosis (TB) as documented by medical history, examination, and TB testing with a positive (not indeterminate) QuantiFERON test.
Significant allergies to humanized monoclonal antibodies as per principal investigator's and GSK medical monitor's judgements.
History or evidence of clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A (IgA) dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).
History of lymphoma, leukaemia, or any malignancy within the last 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
ALT greater than (>)1.5 times upper limit of normal (ULN) .
Bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent [%]).
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Corrected QT (QTc) >450 milliseconds (msec).
History of Stevens Johnson Syndrome.
Known immunodeficiency.
Participants with a chronic infection (for example [e.g.], osteomyelitis), who have been receiving treatment within three months prior to dosing or individuals with an active infection.
Previous or current history of bleeding diathesis, excessive bleeding or coagulation disorders.
History of significant medical illness in the opinion of the investigator would interfere with the study procedures and / or assessments.
Intended use of over-the-counter or prescription medication including herbal medications within 7 days prior to dosing until final follow-up visit.
Live vaccine(s) or plans to receive such vaccines within 1 month of screening until final follow-up visit.
Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing.
Treatment with antiplatelet or anticoagulant agents within 7 days of dosing.
Major surgery (as per investigator's judgement) within 3 months prior to dosing.
Participation in the study would result in loss of blood or blood products in excess of 500 milliliters (mL) within 3 months.
Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.
Current enrolment or past participation in any other clinical study involving an investigational drug intervention within the last 3 months or 5 half-lives (whichever is longer) of signing the ICF.
Presence of Hepatitis B surface antigen (HBsAg) at screening.
Presence of the Hepatitis B core antibody (HBcAb) at screening.
Positive Hepatitis C antibody test result at screening.
Positive Hepatitis C Ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study intervention.
Abnormal clinically significant echocardiogram at screening, as assessed by the investigator.
Cardiac troponin or N-terminal pro B-type natriuretic peptide (NT-proBNP) levels out of normal range at screening.
Positive pre-study drug/alcohol screen.
Positive human immunodeficiency virus (HIV) antibody test.
Positive coronavirus disease 2019 (COVID-19): SARS-CoV2 polymerase chain reaction (PCR) or lateral flow test of a combined throat and nasopharyngeal swab or nasal swab only.
Regular alcohol consumption within 6 months prior to the study defined as: an average weekly intake of >14 units for males and >14 units for females. One unit is equivalent to 8 grams of alcohol: a half-pint (approximately 240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
Regular use of known drugs of abuse.
Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
20 Years
Maximum Age
65 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
GSK Clinical Trials
GlaxoSmithKline
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
GSK Investigational Site
Herston Queensland
Queensland
4006
Australia
GSK Investigational Site
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
IPD for this study will be made available via the Clinical Study Data Request site.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame
IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Of 32 participants who were enrolled and randomized, 1 participant from GSK3858279 Caucasian arm did not receive any study intervention due to high blood pressure (BP). A total of 29 participants completed the study (Placebo: 10 participants [91%] and GSK3858279: 19 participants [95%]).
Recruitment Details
Out of 91 participants screened, 32 participants were enrolled in the study (57 participants were screen failures). The most common reasons for screen failure were not meeting inclusion/exclusion criteria for 45 participants and physician decision for 10 participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
GSK3858279 Caucasian
Participants received 240 milligrams (mg) of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.
FG001
GSK3858279 Chinese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.
FG002
GSK3858279 Japanese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.
FG003
Caucasian Placebo
Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.
FG004
Chinese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.
FG005
Japanese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG0006 subjects
FG0017 subjects
FG0027 subjects
FG0034 subjects
FG0043 subjects
FG0054 subjects
COMPLETED
FG0006 subjects
FG0017 subjects
FG0026 subjects
FG0033 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
GSK3858279 Caucasian
Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.
BG001
GSK3858279 Chinese
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
The Age of the participants was measured in Years of life.
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number Of Participants With Adverse Events (AEs), Serious Adverse Events (SAE's) And Withdrawals Due to AE's
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAEs are defined as any untoward medical occurrence that, at any dose: results in death, cause life threatening events which requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability or incapacity and birth defect or congenital anomaly. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169.
The analysis was performed on the Safety Set that included all randomized participants who received at least one injection of study intervention.
Posted
Count of Participants
Participants
Up to 169 days
ID
Title
Description
Adverse Events Module
Frequency Threshold
0
Time Frame
All AEs and SAEs were collected from the start of the study intervention up to Day 169.
Description
All-cause mortality, Serious adverse events and non-serious adverse events were reported for the Safety Population who were randomized and received at least one dose of study
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
GSK3858279 Caucasian
Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.
Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Drug: Placebo
Placebo
Drug
Placebo will be administered
Caucasian Placebo
Chinese Placebo
Japanese Placebo
Baseline and Day 169
Change From Baseline in White Blood Cell (Wbc) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Blood samples were collected for the assessment of hematology parameters including (WBC) count with differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Baseline and Day 169
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP)
Blood samples were collected for the assessment of clinical chemistry parameters including AST, ALT, AP. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Baseline and Day 169
Change From Baseline in Clinical Chemistry Parameter of Total Protein
Blood samples were collected for the assessment of clinical chemistry parameters including total Protein. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Baseline and Day 169
Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin
Blood samples were collected for the assessment of clinical chemistry parameters including Total bilirubin. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Baseline and Day 169
Change From Baseline in Clinical Chemistry Parameter of Direct Bilirubin, Creatinine
Blood samples were collected for the assessment of clinical chemistry parameters including Direct bilirubin, Creatinine. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Baseline and Day 169
Change From Baseline in Clinical Chemistry Parameter of Urea, Glucose, Potassium, Sodium
Blood samples were collected for the assessment of clinical chemistry parameters including Urea, Glucose, Potassium, Sodium. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Baseline and Day 169
Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)
Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine, indicated as ratio of urine density to water density. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Baseline and Day 169
Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)
Urine samples were collected to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
Baseline and Day 169
Number of Participants With Abnormal Urinalysis Results by Dipstick Method
The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as increase to trace, increase to 1+ (low concentrations present), increase to 2+ (moderate concentrations present) and increase to 3+ (high concentrations present) indicating proportional concentrations in the urine sample. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Data for worst-case post-Baseline relative to Baseline is presented.
Baseline and Day 169
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
The vital sign followed in this analysis was both systolic and diastolic blood pressure, expressed as millimetre of mercury. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Baseline and Day 169
Change From Baseline in Vital Signs: Pulse Rate
The vital signs followed in this analysis was pulse rate, expressed as beats per minute. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Baseline and Day 169
Change From Baseline in Vital Signs: Body Temperature
The vital sign followed in this analysis was body temperature, expressed as degree Celsius. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Baseline and Day 169
Change From Baseline in Vital Signs: Respiratory Rate
The vital signs followed in this analysis was respiratory rate, expressed as Breaths per minute. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
Baseline and Day 169
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) Interval
Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Baseline was defined as the average of the triplicate pre-dose assessments on Day 1 of Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
Baseline and Day 169
Area Under the Plasma Concentration-Time Curve From Time Zero to 56 Days AUC (0-56)] of GSK3858279
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate pharmacokinetic (PK) parameters. PK parameter population consist of all participants in the PK Population, for whom valid and evaluable PK parameters were derived. This population was used in the assessment and characterization of PK parameters.
Predose, 6 Hour (h), 12 h, 24 h, 36 h, 48 h (post dose till Day 3), Day 8, 15, 22, 29, 43 and 57
AUC From Time Zero to the Last Measurable Concentration (0-t) Post-Dose of GSK3858279
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate pharmacokinetic (PK) parameters. PK parameter population consist of all participants in the PK Population, for whom valid and evaluable PK parameters were derived. This population was used in the assessment and characterization of PK parameters.
Predose, 6 Hour (h), 12 h, 24 h, 36 h, 48 h (post dose till Day 3), Day 8, 15, 22, 29, 43, 57, 85, 113, 141, 155 and 169 Days
Time of Occurrence of Last Quantifiable Concentration (Tlast) of GSK3858279
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.
Predose, 6 Hour (h), 12 h, 24 h, 36 h, 48 h (post dose till Day 3), Day 8, 15, 22, 29, 43, 57, 85, 113, 141, 155 and 169 Days
Maximum Observed Concentration (Cmax) of GSK3858279
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.
Predose, 6 Hour (h), 12 h, 24 h, 36 h, 48 h (post dose till Day 3), Day 8, 15, 22, 29, 43, 57, 85, 113, 141, 155 and 169 Days
Time of Occurrence of Cmax (Tmax) of GSK3858279
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.
Predose, 6 Hour (h), 12 h, 24 h, 36 h, 48 h (post dose till Day 3), Day 8, 15, 22, 29, 43, 57, 85, 113, 141, 155 and 169 Days
Baseline (Day 1) and at Days 7, 14, 28 and 56 Post dose
Cmax of Total CCL17 in Serum Following GSK3858279
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.
Baseline (Day 1) and at Days 7, 14, 28 and 56 Post dose
Tmax of Total CCL17 in Serum Following GSK3858279
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters. The study intervention dose was administered on Study Day 1(baseline), where 7 days post-dose totals to Study Day 1+7days = Study Day 8. Following results of Day 8, Day 15, Day 29 and Day 57 corelates to timepoints Day 7, Day 14, Day 28 and Day 56 post dose values and same are presented here.
Baseline (Day 1) and at Days 7, 14, 28 and 56 Post dose
Maximum Fold Change in Total CCL17 in Serum Following GSK3858279 Administration
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.
Baseline (Day 1) and Days 56 Post dose
Fold Increase in Total CCL17 in Serum Following GSK3858279 Administration
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters. The study intervention dose was administered on Study Day 1(baseline), where 7 days post-dose totals to Study Day 1+7days = Study Day 8. Following results of Day 8, Day 15, Day 29 and Day 57 corelates to timepoints Day 7, Day 14, Day 28 and Day 56 post dose values and same are presented here.
Baseline (Day 1) and at Days 7, 14, 28 and 56 Post dose
Number of Participants With Pre-existing Anti-drug Antibodies (ADA's)
Serum samples were collected for the determination of anti- GSK3858279 antibodies (ADA). The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample. Additionally, confirmed positive ADA samples were also tested in a validated neutralizing antibody assay to determine the potential neutralizing activity of the ADA.
Day 169
Number of Participants With Treatment-Emergent ADA's Over Time
Serum samples were collected for the determination of anti- GSK3858279 antibodies (ADA).The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample. Additionally, confirmed positive ADA samples were also tested in a validated neutralizing antibody assay to determine the potential neutralizing activity of the ADA.
Day 169
Melbourne
Victoria
3004
Australia
3 subjects
FG0054 subjects
0 subjects
FG0050 subjects
1 subjects
FG0040 subjects
FG0050 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.
BG002
GSK3858279 Japanese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.
BG003
Caucasian Placebo
Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.
BG004
Chinese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.
BG005
Japanese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
BG006
Total
Total of all reporting groups
6
BG0017
BG0027
BG0034
BG0043
BG0054
BG00631
Count of Participants
Participants
Title
Denominators
Categories
20 - 65 (years of age)
Title
Measurements
BG0006
BG0017
BG0027
BG0034
BG0043
BG0054
BG00631
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0010
BG0020
BG0031
BG0040
BG0050
BG0061
Male
BG0006
BG0017
BG0027
BG0033
BG004
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
ASIAN
Title
Measurements
BG0000
BG0017
BG0027
BG0030
BG0043
BG0054
BG00621
WHITE
Title
Measurements
BG0006
BG0010
BG0020
BG003
OG000
GSK3858279 Caucasian
Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.
OG001
GSK3858279 Chinese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.
OG002
GSK3858279 Japanese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.
OG003
Caucasian Placebo
Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.
OG004
Chinese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.
OG005
Japanese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Units
Counts
Participants
OG0006
OG0017
OG0027
OG0034
OG0043
OG0054
Title
Denominators
Categories
AE
Title
Measurements
OG0005
OG0016
OG0022
OG0034
OG0041
OG0052
SAE
Title
Measurements
OG0000
OG0010
OG0020
OG003
Withdrawals Due to AE
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Change From Baseline in Hematology Parameter of Platelet Count
Blood samples were collected for the assessment of change from baseline in hematology parameter platelet count. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
The analysis was performed on the Safety Set that included all randomized participants who received at least one injection of study intervention.
Posted
Mean
Standard Deviation
Giga cells per liter (10^9/L)
Baseline and Day 169
ID
Title
Description
OG000
GSK3858279 Caucasian
Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.
OG001
GSK3858279 Chinese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.
OG002
GSK3858279 Japanese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.
OG003
Caucasian Placebo
Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.
OG004
Chinese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.
OG005
Japanese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Units
Counts
Participants
OG0006
OG0017
OG0027
OG003
Title
Denominators
Categories
Title
Measurements
OG0002.8± 25.90
OG00118.0± 18.81
OG002-4.2± 12.27
OG003
Primary
Change From Baseline in Hematology Parameter of Hemoglobin
Blood samples were collected for the assessment of change from baseline in hematology parameters Hemoglobin. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
The analysis was performed on the Safety Set that included all randomized participants who received at least one injection of study intervention.
Posted
Mean
Standard Deviation
Gram Per Liter (g/L)
Baseline and Day 169
ID
Title
Description
OG000
GSK3858279 Caucasian
Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.
OG001
GSK3858279 Chinese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.
OG002
GSK3858279 Japanese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.
OG003
Caucasian Placebo
Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.
OG004
Chinese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.
OG005
Japanese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Units
Counts
Participants
OG0006
OG0017
OG0027
OG003
Title
Denominators
Categories
Title
Measurements
OG000-7.5± 13.79
OG001-6.0± 10.42
OG002-2.0± 10.79
OG003
Primary
Change From Baseline in Hematology Parameter of Hematocrit
Blood samples were collected for the assessment of change from baseline in hematology parameters Hematocrit. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
The analysis was performed on the Safety Set that included all randomized participants who received at least one injection of study intervention.
Posted
Mean
Standard Deviation
Liter/liter (L/L)
Baseline and Day 169
ID
Title
Description
OG000
GSK3858279 Caucasian
Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.
OG001
GSK3858279 Chinese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.
OG002
GSK3858279 Japanese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.
OG003
Caucasian Placebo
Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.
OG004
Chinese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.
OG005
Japanese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Units
Counts
Participants
OG0006
OG0017
OG0027
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.027± 0.0367
OG001-0.010± 0.0408
OG002-0.005± 0.0259
OG003
Primary
Change From Baseline in White Blood Cell (Wbc) Count With Differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Blood samples were collected for the assessment of hematology parameters including (WBC) count with differential i.e. Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
The analysis was performed on the Safety Set that included all randomized participants who received at least one injection of study intervention. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for specified time points.
Posted
Mean
Standard Deviation
Giga cells per liter (10^9/L)
Baseline and Day 169
ID
Title
Description
OG000
GSK3858279 Caucasian
Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.
OG001
GSK3858279 Chinese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.
OG002
GSK3858279 Japanese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.
OG003
Caucasian Placebo
Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.
OG004
Chinese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.
OG005
Japanese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Units
Counts
Participants
OG0006
OG0012
OG0025
OG003
Title
Denominators
Categories
Basophils
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0024
ParticipantsOG003
Primary
Change From Baseline in Clinical Chemistry Parameter of Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase (AP)
Blood samples were collected for the assessment of clinical chemistry parameters including AST, ALT, AP. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
The analysis was performed on the Safety Set that included all randomized participants who received at least one injection of study intervention. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for specified time points.
Posted
Mean
Standard Deviation
Units per liter (U/L)
Baseline and Day 169
ID
Title
Description
OG000
GSK3858279 Caucasian
Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.
OG001
GSK3858279 Chinese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.
OG002
GSK3858279 Japanese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.
OG003
Caucasian Placebo
Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.
OG004
Chinese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.
OG005
Japanese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Units
Counts
Participants
OG0006
OG0014
OG0026
OG003
Title
Denominators
Categories
Alkaline Phosphatase (AP)
Title
Measurements
OG0000.8± 12.16
OG0011.3± 6.34
OG002-6.5± 14.18
OG003
Primary
Change From Baseline in Clinical Chemistry Parameter of Total Protein
Blood samples were collected for the assessment of clinical chemistry parameters including total Protein. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
The analysis was performed on the Safety Set that included all randomized participants who received at least one injection of study intervention.
Posted
Mean
Standard Deviation
Gram Per Liter (g/L)
Baseline and Day 169
ID
Title
Description
OG000
GSK3858279 Caucasian
Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.
OG001
GSK3858279 Chinese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.
OG002
GSK3858279 Japanese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.
OG003
Caucasian Placebo
Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.
OG004
Chinese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.
OG005
Japanese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Units
Counts
Participants
OG0006
OG0017
OG0027
OG003
Title
Denominators
Categories
Title
Measurements
OG0002.2± 1.94
OG0012.5± 2.89
OG0020.8± 4.45
OG003
Primary
Change From Baseline in Clinical Chemistry Parameter of Total Bilirubin
Blood samples were collected for the assessment of clinical chemistry parameters including Total bilirubin. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
The analysis was performed on the Safety Set that included all randomized participants who received at least one injection of study intervention.
Posted
Mean
Standard Deviation
micromole per liter (umol/L)
Baseline and Day 169
ID
Title
Description
OG000
GSK3858279 Caucasian
Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.
OG001
GSK3858279 Chinese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.
OG002
GSK3858279 Japanese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.
OG003
Caucasian Placebo
Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.
OG004
Chinese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.
OG005
Japanese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Units
Counts
Participants
OG0006
OG0017
OG0027
OG003
Title
Denominators
Categories
Title
Measurements
OG000-5.3± 3.88
OG001-0.3± 4.79
OG002-1.5± 3.73
OG003
Primary
Change From Baseline in Clinical Chemistry Parameter of Direct Bilirubin, Creatinine
Blood samples were collected for the assessment of clinical chemistry parameters including Direct bilirubin, Creatinine. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
The analysis was performed on the Safety Set that included all randomized participants who received at least one injection of study intervention. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for specified time points.
Posted
Mean
Standard Deviation
micromole per liter (umol/L)
Baseline and Day 169
ID
Title
Description
OG000
GSK3858279 Caucasian
Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.
OG001
GSK3858279 Chinese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.
OG002
GSK3858279 Japanese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.
OG003
Caucasian Placebo
Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.
OG004
Chinese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.
OG005
Japanese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Units
Counts
Participants
OG0006
OG0014
OG0026
OG003
Title
Denominators
Categories
Direct Bilirubin,
Title
Measurements
OG000-1.8± 1.47
OG0010.0± 2.16
OG002-0.3± 0.82
OG003
Primary
Change From Baseline in Clinical Chemistry Parameter of Urea, Glucose, Potassium, Sodium
Blood samples were collected for the assessment of clinical chemistry parameters including Urea, Glucose, Potassium, Sodium. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
The analysis was performed on the Safety Set that included all randomized participants who received at least one injection of study intervention. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for specified time points.
Posted
Mean
Standard Deviation
millimoles per liter (mmol/L)
Baseline and Day 169
ID
Title
Description
OG000
GSK3858279 Caucasian
Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.
OG001
GSK3858279 Chinese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.
OG002
GSK3858279 Japanese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.
OG003
Caucasian Placebo
Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.
OG004
Chinese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.
OG005
Japanese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Units
Counts
Participants
OG0006
OG0014
OG0026
OG003
Title
Denominators
Categories
Glucose
Title
Measurements
OG0000.25± 0.575
OG0010.03± 0.171
OG0020.18± 0.549
OG003
Primary
Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Specific Gravity (Ratio of Urine Density to Water Density)
Urine samples were collected to analyze the urinalysis parameter: specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine, indicated as ratio of urine density to water density. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
The analysis was performed on the Safety Set that included all randomized participants who received at least one injection of study intervention.
Posted
Count of Participants
Participants
Baseline and Day 169
ID
Title
Description
OG000
GSK3858279 Caucasian
Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.
OG001
GSK3858279 Chinese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.
OG002
GSK3858279 Japanese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.
OG003
Caucasian Placebo
Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.
OG004
Chinese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.
OG005
Japanese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Units
Counts
Participants
OG0006
OG0017
OG0027
OG003
Title
Denominators
Categories
Any Increase
Title
Measurements
OG0006
OG0017
OG0027
OG003
Primary
Number of Participants With Change From Baseline in Urinalysis Parameter: Urine Potential of Hydrogen (pH)
Urine samples were collected to analyze the urinalysis parameter: pH. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated as post-dose visit value minus the Baseline value.
The analysis was performed on the Safety Set that included all randomized participants who received at least one injection of study intervention.
Posted
Count of Participants
Participants
Baseline and Day 169
ID
Title
Description
OG000
GSK3858279 Caucasian
Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.
OG001
GSK3858279 Chinese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.
OG002
GSK3858279 Japanese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.
OG003
Caucasian Placebo
Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.
OG004
Chinese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.
OG005
Japanese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Units
Counts
Participants
OG0006
OG0017
OG0027
OG003
Title
Denominators
Categories
Any Increase
Title
Measurements
OG0005
OG0016
OG0024
OG003
Primary
Number of Participants With Abnormal Urinalysis Results by Dipstick Method
The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as increase to trace, increase to 1+ (low concentrations present), increase to 2+ (moderate concentrations present) and increase to 3+ (high concentrations present) indicating proportional concentrations in the urine sample. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Data for worst-case post-Baseline relative to Baseline is presented.
The analysis was performed on the Safety Set that included all randomized participants who received at least one injection of study intervention.
Posted
Count of Participants
Participants
Baseline and Day 169
ID
Title
Description
OG000
GSK3858279 Caucasian
Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.
OG001
GSK3858279 Chinese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.
OG002
GSK3858279 Japanese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.
OG003
Caucasian Placebo
Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.
OG004
Chinese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.
OG005
Japanese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Units
Counts
Participants
OG0006
OG0017
OG0027
OG003
Title
Denominators
Categories
Bilirubin, Any Increase
Title
Measurements
OG0001
OG0011
OG0021
OG003
Primary
Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
The vital sign followed in this analysis was both systolic and diastolic blood pressure, expressed as millimetre of mercury. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
The analysis was performed on the Safety Set that included all randomized participants who received at least one injection of study intervention. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for specified time points.
Posted
Mean
Standard Deviation
Millimetre of Mercury (mmHg)
Baseline and Day 169
ID
Title
Description
OG000
GSK3858279 Caucasian
Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.
OG001
GSK3858279 Chinese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.
OG002
GSK3858279 Japanese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.
OG003
Caucasian Placebo
Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.
OG004
Chinese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.
OG005
Japanese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Units
Counts
Participants
OG0006
OG0014
OG0026
OG003
Title
Denominators
Categories
Systolic Blood Pressure
Title
Measurements
OG0005.3± 13.00
OG0010.8± 7.37
OG0020.8± 6.18
OG003
Primary
Change From Baseline in Vital Signs: Pulse Rate
The vital signs followed in this analysis was pulse rate, expressed as beats per minute. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
The analysis was performed on the Safety Set that included all randomized participants who received at least one injection of study intervention.
Posted
Mean
Standard Deviation
Beats per minute (bpm)
Baseline and Day 169
ID
Title
Description
OG000
GSK3858279 Caucasian
Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.
OG001
GSK3858279 Chinese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.
OG002
GSK3858279 Japanese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.
OG003
Caucasian Placebo
Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.
OG004
Chinese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.
OG005
Japanese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Units
Counts
Participants
OG0006
OG0017
OG0027
OG003
Title
Denominators
Categories
Title
Measurements
OG0006.5± 11.74
OG00116.0± 18.17
OG0026.8± 11.58
OG003
Primary
Change From Baseline in Vital Signs: Body Temperature
The vital sign followed in this analysis was body temperature, expressed as degree Celsius. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
The analysis was performed on the Safety Set that included all randomized participants who received at least one injection of study intervention.
Posted
Mean
Standard Deviation
Degree Celsius
Baseline and Day 169
ID
Title
Description
OG000
GSK3858279 Caucasian
Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.
OG001
GSK3858279 Chinese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.
OG002
GSK3858279 Japanese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.
OG003
Caucasian Placebo
Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.
OG004
Chinese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.
OG005
Japanese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Units
Counts
Participants
OG0006
OG0017
OG0027
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.07± 0.468
OG001-0.03± 0.330
OG0020.48± 0.436
OG003
Primary
Change From Baseline in Vital Signs: Respiratory Rate
The vital signs followed in this analysis was respiratory rate, expressed as Breaths per minute. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Change from Baseline was defined as value at the indicated time point minus Baseline value.
The analysis was performed on the Safety Set that included all randomized participants who received at least one injection of study intervention.
Posted
Mean
Standard Deviation
Breaths per minute
Baseline and Day 169
ID
Title
Description
OG000
GSK3858279 Caucasian
Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.
OG001
GSK3858279 Chinese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.
OG002
GSK3858279 Japanese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.
OG003
Caucasian Placebo
Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.
OG004
Chinese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.
OG005
Japanese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Units
Counts
Participants
OG0006
OG0017
OG0027
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.5± 1.76
OG001-0.8± 0.96
OG002-1.0± 1.67
OG003
Primary
Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF) Interval
Twelve-lead ECG were obtained to measure PR Interval, QRS Duration, QT Interval, QTcF Interval and QTcB Interval. Twelve-lead ECGs were performed with the participant in a supine or semi-supine position after a rest of at least 10 minutes. The final follow-up visit was on Day 169 for participants in the Caucasian cohort and on Day 113 for Chinese and Japanese participants respectively (NB: Japanese and Chinese participants had an option to remain in the study until Day 169). Baseline was defined as the average of the triplicate pre-dose assessments on Day 1 of Period 2. Change from Baseline was calculated by subtracting the post-dose visit value from the Baseline value.
The analysis was performed on the Safety Set that included all randomized participants who received at least one injection of study intervention. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for specified time points.
Posted
Mean
Standard Deviation
milliseconds (msec)
Baseline and Day 169
ID
Title
Description
OG000
GSK3858279 Caucasian
Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.
OG001
GSK3858279 Chinese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.
OG002
GSK3858279 Japanese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.
OG003
Caucasian Placebo
Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.
OG004
Chinese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.
OG005
Japanese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Units
Counts
Participants
OG0006
OG0014
OG0026
OG003
Title
Denominators
Categories
PR Interval
Title
Measurements
OG000-5.000± 6.4601
OG001-4.000± 7.4486
OG002-7.889± 21.1152
OG003
Primary
Area Under the Plasma Concentration-Time Curve From Time Zero to 56 Days AUC (0-56)] of GSK3858279
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate pharmacokinetic (PK) parameters. PK parameter population consist of all participants in the PK Population, for whom valid and evaluable PK parameters were derived. This population was used in the assessment and characterization of PK parameters.
All participants in the safety population who received an active dose of study treatment and had at least one reportable Pharmacokinetic (PK) assessment.
Posted
Geometric Mean
Geometric Coefficient of Variation
day* nanograms per milliliter (ng/mL)
Predose, 6 Hour (h), 12 h, 24 h, 36 h, 48 h (post dose till Day 3), Day 8, 15, 22, 29, 43 and 57
ID
Title
Description
OG000
GSK3858279 Caucasian
Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.
OG001
GSK3858279 Chinese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.
OG002
GSK3858279 Japanese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.
Units
Counts
Participants
OG0006
OG0017
OG0027
Title
Denominators
Categories
Title
Measurements
OG00087592.7± 15.8
OG00186412.2± 28.2
OG00277742.0± 22.5
Primary
AUC From Time Zero to the Last Measurable Concentration (0-t) Post-Dose of GSK3858279
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate pharmacokinetic (PK) parameters. PK parameter population consist of all participants in the PK Population, for whom valid and evaluable PK parameters were derived. This population was used in the assessment and characterization of PK parameters.
All participants in the safety population who received an active dose of study treatment and had at least one reportable PK assessment.
Posted
Geometric Mean
Geometric Coefficient of Variation
day*nanograms per milliliter (day*ng/mL)
Predose, 6 Hour (h), 12 h, 24 h, 36 h, 48 h (post dose till Day 3), Day 8, 15, 22, 29, 43, 57, 85, 113, 141, 155 and 169 Days
ID
Title
Description
OG000
GSK3858279 Caucasian
Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.
OG001
GSK3858279 Chinese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.
OG002
GSK3858279 Japanese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.
Units
Counts
Participants
OG0006
OG0017
OG0027
Title
Denominators
Categories
Title
Measurements
OG00088679.6± 17.6
OG00187201.8± 29.1
OG00277009.4± 21.0
Primary
Time of Occurrence of Last Quantifiable Concentration (Tlast) of GSK3858279
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.
All participants in the safety population who received an active dose of study treatment and had at least one reportable PK assessment.
Posted
Median
Full Range
day
Predose, 6 Hour (h), 12 h, 24 h, 36 h, 48 h (post dose till Day 3), Day 8, 15, 22, 29, 43, 57, 85, 113, 141, 155 and 169 Days
ID
Title
Description
OG000
GSK3858279 Caucasian
Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.
OG001
GSK3858279 Chinese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.
OG002
GSK3858279 Japanese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.
Units
Counts
Participants
OG0006
OG0017
OG0027
Title
Denominators
Categories
Title
Measurements
OG00056.115(41.83 to 84.92)
OG00156.062(54.93 to 84.06)
OG00255.964(14.01 to 58.01)
Primary
Maximum Observed Concentration (Cmax) of GSK3858279
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.
All participants in the safety population who received an active dose of study treatment and had at least one reportable PK assessment.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms per milliliter (ng/mL)
Predose, 6 Hour (h), 12 h, 24 h, 36 h, 48 h (post dose till Day 3), Day 8, 15, 22, 29, 43, 57, 85, 113, 141, 155 and 169 Days
ID
Title
Description
OG000
GSK3858279 Caucasian
Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.
OG001
GSK3858279 Chinese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.
OG002
GSK3858279 Japanese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.
Units
Counts
Participants
OG0006
OG0017
OG0027
Title
Denominators
Categories
Title
Measurements
OG0009135.3± 42.0
OG0016851.4± 41.4
OG0028295.4± 39.8
Primary
Time of Occurrence of Cmax (Tmax) of GSK3858279
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.
All participants in the safety population who received an active dose of study treatment and had at least one reportable PK assessment.
Posted
Median
Full Range
day
Predose, 6 Hour (h), 12 h, 24 h, 36 h, 48 h (post dose till Day 3), Day 8, 15, 22, 29, 43, 57, 85, 113, 141, 155 and 169 Days
ID
Title
Description
OG000
GSK3858279 Caucasian
Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.
OG001
GSK3858279 Chinese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.
OG002
GSK3858279 Japanese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.
Units
Counts
Participants
OG0006
OG0017
OG0027
Title
Denominators
Categories
Title
Measurements
OG0002.004(1.50 to 7.03)
OG0013.919(1.50 to 7.18)
OG0023.217(1.00 to 4.15)
Secondary
Percentage Change From Baseline in Free CCL17
Blood samples were collected from participants at time points after the administration of study treatment to investigate PK parameters. The study intervention dose was administered on Study Day 1(baseline), where 7 days post-dose totals to Study Day 1+7days = Study Day 8. Following results of Day 8, Day 15, Day 29 and Day 57 corelates to timepoints Day 7, Day 14, Day 28 and Day 56 post dose values and same are presented here.
All participants in the safety population who had at least one reportable Target Engagement (TE) assessment.
Posted
Geometric Mean
95% Confidence Interval
Percent change (%)
Baseline (Day 1) and at Days 7, 14, 28 and 56 Post dose
ID
Title
Description
OG000
GSK3858279 Caucasian
Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.
OG001
GSK3858279 Chinese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.
OG002
GSK3858279 Japanese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.
OG003
Caucasian Placebo
Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.
OG004
Chinese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.
OG005
Japanese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Units
Counts
Participants
OG0006
OG0017
OG0027
OG003
Title
Denominators
Categories
Day 8, Percent change
ParticipantsOG0006
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG003
Secondary
Cmax of Total CCL17 in Serum Following GSK3858279
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.
All participants in the safety population who had at least one reportable TE assessment.
Posted
Geometric Mean
Geometric Coefficient of Variation
Picogram per milliliter (pg/mL)
Baseline (Day 1) and at Days 7, 14, 28 and 56 Post dose
ID
Title
Description
OG000
GSK3858279 Caucasian
Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.
OG001
GSK3858279 Chinese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.
OG002
GSK3858279 Japanese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.
OG003
Caucasian Placebo
Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.
OG004
Chinese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.
OG005
Japanese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Units
Counts
Participants
OG0006
OG0017
OG0027
OG003
Title
Denominators
Categories
Title
Measurements
OG00068969.794± 30.025
OG00162648.760± 29.529
OG00255177.740± 20.370
OG003
Secondary
Tmax of Total CCL17 in Serum Following GSK3858279
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters. The study intervention dose was administered on Study Day 1(baseline), where 7 days post-dose totals to Study Day 1+7days = Study Day 8. Following results of Day 8, Day 15, Day 29 and Day 57 corelates to timepoints Day 7, Day 14, Day 28 and Day 56 post dose values and same are presented here.
All participants in the safety population who had at least one reportable TE assessment.
Posted
Mean
Standard Deviation
day
Baseline (Day 1) and at Days 7, 14, 28 and 56 Post dose
ID
Title
Description
OG000
GSK3858279 Caucasian
Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.
OG001
GSK3858279 Chinese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.
OG002
GSK3858279 Japanese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.
OG003
Caucasian Placebo
Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.
OG004
Chinese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.
OG005
Japanese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Units
Counts
Participants
OG0006
OG0017
OG0027
OG003
Title
Denominators
Categories
Title
Measurements
OG0009.333± 5.7155
OG00114.000± 4.0415
OG0028.571± 3.8668
OG003
Secondary
Maximum Fold Change in Total CCL17 in Serum Following GSK3858279 Administration
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters.
All participants in the safety population who had at least one reportable TE assessment.
Posted
Geometric Mean
Geometric Coefficient of Variation
Fold Change
Baseline (Day 1) and Days 56 Post dose
ID
Title
Description
OG000
GSK3858279 Caucasian
Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.
OG001
GSK3858279 Chinese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.
OG002
GSK3858279 Japanese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.
OG003
Caucasian Placebo
Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.
OG004
Chinese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.
OG005
Japanese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Units
Counts
Participants
OG0006
OG0017
OG0027
OG003
Title
Denominators
Categories
Title
Measurements
OG00077.479± 4.674
OG001113.436± 34.212
OG00273.474± 58.664
OG003
Secondary
Fold Increase in Total CCL17 in Serum Following GSK3858279 Administration
Blood samples were collected from participants at indicated time points after the administration of study treatment to investigate PK parameters. The study intervention dose was administered on Study Day 1(baseline), where 7 days post-dose totals to Study Day 1+7days = Study Day 8. Following results of Day 8, Day 15, Day 29 and Day 57 corelates to timepoints Day 7, Day 14, Day 28 and Day 56 post dose values and same are presented here.
All participants in the safety population who had at least one reportable TE assessment.
Posted
Geometric Mean
95% Confidence Interval
Fold Change
Baseline (Day 1) and at Days 7, 14, 28 and 56 Post dose
ID
Title
Description
OG000
GSK3858279 Caucasian
Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.
OG001
GSK3858279 Chinese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.
OG002
GSK3858279 Japanese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.
OG003
Caucasian Placebo
Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.
OG004
Chinese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.
OG005
Japanese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Units
Counts
Participants
OG0006
OG0017
OG0027
OG003
Title
Denominators
Categories
Day 8
Title
Measurements
OG00076.489(70.870 to 82.552)
OG00193.537(76.813 to 113.903)
OG00270.025(42.278 to 115.981)
Secondary
Number of Participants With Pre-existing Anti-drug Antibodies (ADA's)
Serum samples were collected for the determination of anti- GSK3858279 antibodies (ADA). The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample. Additionally, confirmed positive ADA samples were also tested in a validated neutralizing antibody assay to determine the potential neutralizing activity of the ADA.
All participants in the safety population who had at least one reportable TE assessment.
Posted
Count of Participants
Participants
Day 169
ID
Title
Description
OG000
GSK3858279 Caucasian
Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.
OG001
GSK3858279 Chinese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.
OG002
GSK3858279 Japanese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.
OG003
Caucasian Placebo
Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.
OG004
Chinese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.
OG005
Japanese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Units
Counts
Participants
OG0006
OG0017
OG0027
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Number of Participants With Treatment-Emergent ADA's Over Time
Serum samples were collected for the determination of anti- GSK3858279 antibodies (ADA).The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample. Additionally, confirmed positive ADA samples were also tested in a validated neutralizing antibody assay to determine the potential neutralizing activity of the ADA.
All participants in the safety population who had at least one reportable TE assessment.
Posted
Count of Participants
Participants
Day 169
ID
Title
Description
OG000
GSK3858279 Caucasian
Participants received 240 mg of GSK3858279 administered as separate subcutaneous (SC) injection to healthy Caucasian participants.
OG001
GSK3858279 Chinese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.
OG002
GSK3858279 Japanese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.
OG003
Caucasian Placebo
Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.
OG004
Chinese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.
OG005
Japanese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
Units
Counts
Participants
OG0006
OG0017
OG0027
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
0
6
0
6
5
6
EG001
GSK3858279 Chinese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Chinese participants.
0
7
0
7
6
7
EG002
GSK3858279 Japanese
Participants received 240 mg of GSK3858279 administered as separate SC injection to healthy Japanese participants.
0
7
0
7
2
7
EG003
Caucasian Placebo
Participants received single dose of Placebo administered as separate SC injection to healthy Caucasian participants.
0
4
0
4
4
4
EG004
Chinese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Chinese participants.
0
3
0
3
1
3
EG005
Japanese Placebo
Participants received Single dose of Placebo administered as separate SC injection to healthy Japanese participants.
0
4
0
4
2
4
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected4 at risk
Dental caries
Gastrointestinal disorders
v25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
Diarrhoea
Gastrointestinal disorders
v25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0031 events1 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
Injection site bruising
General disorders
v25.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
Injection site pain
General disorders
v25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected4 at risk
COVID-19
Infections and infestations
v25.0
Systematic Assessment
EG0003 events3 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
Gastroenteritis
Infections and infestations
v25.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
Skin candida
Infections and infestations
v25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0031 events1 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
Upper respiratory tract infection
Infections and infestations
v25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected7 at risk
EG0032 events2 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
Viral upper respiratory tract infection
Infections and infestations
v25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
Eyelid injury
Injury, poisoning and procedural complications
v25.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
Limb injury
Injury, poisoning and procedural complications
v25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0051 events1 affected4 at risk
Alanine aminotransferase increased
Investigations
v25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
Aspartate aminotransferase increased
Investigations
v25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
Back pain
Musculoskeletal and connective tissue disorders
v25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
Costochondritis
Musculoskeletal and connective tissue disorders
v25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0031 events1 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
Muscle spasms
Musculoskeletal and connective tissue disorders
v25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0031 events1 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
Tendonitis
Musculoskeletal and connective tissue disorders
v25.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
Dizziness
Nervous system disorders
v25.0
Systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
Sedation
Nervous system disorders
v25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
Insomnia
Psychiatric disorders
v25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
Nephrolithiasis
Renal and urinary disorders
v25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected4 at risk
Skin irritation
Skin and subcutaneous tissue disorders
v25.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected4 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected4 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
3
BG0054
BG00630
4
BG0040
BG0050
BG00610
0
OG0040
OG0050
0
OG0040
OG0050
4
OG0043
OG0054
7.0
± 15.59
OG00416.0± 39.60
OG005-12.3± 6.51
4
OG0043
OG0054
-5.3
± 7.37
OG004-10.5± 16.26
OG005-3.0± 3.61
4
OG0043
OG0054
-0.027
± 0.0321
OG004-0.035± 0.0495
OG005-0.013± 0.0208
3
OG0042
OG0053
1
ParticipantsOG0042
ParticipantsOG0053
Title
Measurements
OG0000.01± 0.020
OG0010.00± 0.000
OG0020.00± 0.000
OG0030.00± 0.00
OG004-0.03± 0.035
OG0050.00± 0.000
Eosinophils
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0025
ParticipantsOG0033
ParticipantsOG0042
ParticipantsOG0053
Title
Measurements
OG0000.00± 0.084
OG001-0.03± 0.035
OG0020.02± 0.135
OG003
Lymphocytes
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0025
ParticipantsOG0033
ParticipantsOG0042
ParticipantsOG0053
Title
Measurements
OG0000.02± 0.172
OG0010.10± 0.141
OG0020.04± 0.261
OG003
Monocytes
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0025
ParticipantsOG0033
ParticipantsOG0042
ParticipantsOG0053
Title
Measurements
OG0000.00± 0.063
OG0010.05± 0.071
OG0020.10± 0.122
OG003
Neutrophils
ParticipantsOG0006
ParticipantsOG0012
ParticipantsOG0025
ParticipantsOG0033
ParticipantsOG0042
ParticipantsOG0053
Title
Measurements
OG000-0.12± 0.791
OG001-0.25± 0.212
OG0020.54± 1.001
OG003
3
OG0042
OG0053
0.0
± 7.94
OG004-3.0± 8.49
OG005-4.3± 11.06
Alanine Aminotransferase (ALT)
Title
Measurements
OG0003.2± 9.70
OG0019.3± 17.25
OG0024.0± 4.15
OG00317.3± 5.13
OG004-3.0± 5.66
OG005-2.0± 11.79
Aspartate Aminotransferase (AST)
Title
Measurements
OG0002.3± 5.72
OG00112.0± 19.37
OG0020.8± 6.74
OG00311.0± 3.61
OG0041.0± 4.24
OG005-1.3± 3.06
4
OG0043
OG0054
0.3
± 2.52
OG004-0.5± 4.95
OG0053.3± 1.53
4
OG0043
OG0054
-4.7
± 1.53
OG0040.5± 2.12
OG0051.3± 6.03
3
OG0042
OG0053
-1.7
± 0.58
OG0040.0± 1.41
OG0051.3± 3.51
Creatinine
Title
Measurements
OG0001.8± 8.86
OG001-1.8± 8.85
OG0023.0± 4.94
OG0035.7± 10.69
OG00414.5± 7.78
OG0050.0± 3.61
3
OG0042
OG0053
0.23
± 0.651
OG0041.10± 1.980
OG0050.27± 0.208
Potassium
Title
Measurements
OG0000.00± 0.400
OG001-0.08± 0.189
OG002-0.15± 0.302
OG0030.33± 0.115
OG004-0.45± 0.212
OG0050.03± 0.058
Sodium
Title
Measurements
OG0001.8± 0.98
OG001-1.8± 3.40
OG0020.5± 3.02
OG0030.7± 1.53
OG0040.0± 1.41
OG0051.0± 0.00
Urea
Title
Measurements
OG0001.43± 0.907
OG0010.38± 1.715
OG0020.87± 1.718
OG0031.03± 0.862
OG0041.45± 0.495
OG0051.13± 0.723
4
OG0043
OG0054
4
OG0043
OG0054
Increase to 1.019
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
Increase to 1.02
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
Increase to 1.021
Title
Measurements
OG0001
OG0010
OG0020
OG0031
OG0040
OG0050
Increase to 1.024
Title
Measurements
OG0000
OG0010
OG0022
OG0030
OG0040
OG0050
Increase to 1.025
Title
Measurements
OG0001
OG0011
OG0020
OG0031
OG0040
OG0050
Increase to 1.026
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0050
Increase to 1.027
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
Increase to 1.028
Title
Measurements
OG0000
OG0011
OG0020
OG0031
OG0040
OG0050
Increase to 1.029
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0051
Increase to 1.03
Title
Measurements
OG0000
OG0013
OG0020
OG0030
OG0041
OG0050
Increase to 1.031
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
Increase to 1.032
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0041
OG0052
Increase to 1.033
Title
Measurements
OG0000
OG0011
OG0021
OG0030
OG0040
OG0051
Increase to 1.034
Title
Measurements
OG0001
OG0010
OG0021
OG0030
OG0040
OG0050
Increase to 1.036
Title
Measurements
OG0001
OG0011
OG0020
OG0030
OG0040
OG0050
4
OG0043
OG0054
2
OG0042
OG0053
Increase to 6.5
Title
Measurements
OG0001
OG0012
OG0020
OG0030
OG0040
OG0050
Increase to 7.0
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0051
Increase to 7.5
Title
Measurements
OG0001
OG0012
OG0022
OG0030
OG0042
OG0052
Increase to 8.0
Title
Measurements
OG0001
OG0012
OG0022
OG0032
OG0040
OG0050
Increase to 8.5
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
4
OG0043
OG0054
0
OG0040
OG0050
Bilirubin, Increase to TRACE
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Bilirubin, Increase to 1+
Title
Measurements
OG0001
OG0011
OG0021
OG0030
OG0040
OG0050
Bilirubin, Increase to 2+
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Bilirubin, Increase to 3+
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Bilirubin, Increase to 4+
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Glucose, Any Increase
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Glucose, Increase to TRACE
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Glucose, Increase to 1+
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Glucose, Increase to 2+
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Glucose, Increase to 3+
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Glucose, Increase to 4+
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Ketones, Any Increase
Title
Measurements
OG0003
OG0015
OG0024
OG0032
OG0043
OG0051
Ketones, Increase to TRACE
Title
Measurements
OG0003
OG0015
OG0023
OG0032
OG0043
OG0051
Ketones, Increase to 1+
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Ketones, Increase to 2+
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
Ketones, Increase to 3+
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Ketones, Increase to 4+
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Leukocyte Esterase, Any Increase
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0051
Leukocyte Esterase, Increase to TRACE
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Leukocyte Esterase, Increase to 1+
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0051
Leukocyte Esterase, Increase to 2+
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Leukocyte Esterase, Increase to 3+
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Leukocyte Esterase, Increase to 4+
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Nitrite, Any Increase
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Nitrite, Increase to POSITIVE
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Occult Blood, Any Increase
Title
Measurements
OG0001
OG0011
OG0021
OG0031
OG0040
OG0050
Occult Blood, Increase to TRACE
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0050
Occult Blood, Increase to 1+
Title
Measurements
OG0001
OG0010
OG0021
OG0030
OG0040
OG0050
Occult Blood, Increase to 2+
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0050
Occult Blood, Increase to 3+
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Occult Blood, Increase to 4+
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Protein, Any Increase
Title
Measurements
OG0002
OG0012
OG0022
OG0031
OG0040
OG0052
Protein, Increase to TRACE
Title
Measurements
OG0002
OG0011
OG0022
OG0031
OG0040
OG0052
Protein, Increase to 1+
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0050
Protein, Increase to 2+
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Protein, Increase to 3+
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Protein, Increase to 4+
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Urobilinogen, Any Increase
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
Urobilinogen, Increase to TRACE
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Urobilinogen, Increase to 1+
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Urobilinogen, Increase to 2+
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Urobilinogen, Increase to 3+
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
Urobilinogen, Increase to 4+
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
3
OG0042
OG0053
-1.0
± 7.21
OG0045.0± 5.66
OG0050.0± 5.00
Diastolic Blood Pressure
Title
Measurements
OG0005.2± 10.26
OG0014.0± 2.00
OG0023.5± 8.24
OG0031.3± 4.73
OG0048.5± 12.02
OG005-1.0± 3.61
4
OG0043
OG0054
6.7
± 6.03
OG00410.0± 1.41
OG0054.3± 9.02
4
OG0043
OG0054
-0.10
± 0.500
OG0040.00± 0.141
OG005-0.03± 0.115
4
OG0043
OG0054
-2.0
± 2.00
OG004-0.5± 2.12
OG005-0.7± 2.31
3
OG0042
OG0053
-15.778
± 7.5817
OG004-8.167± 4.4783
OG0056.111± 12.6242
QRS Duration
Title
Measurements
OG000-2.833± 7.9631
OG001-2.083± 4.7561
OG002-0.444± 8.8410
OG0031.667± 6.2272
OG0043.167± 3.5355
OG005-3.667± 4.5092
QT Interval
Title
Measurements
OG000-16.278± 26.0431
OG001-7.083± 15.8052
OG002-18.056± 33.7859
OG003-15.222± 16.4057
OG004-21.333± 26.8701
OG005-7.111± 14.6148
QTcB Interval
Title
Measurements
OG0004.333± 12.5131
OG0015.917± 8.7575
OG0027.333± 8.8292
OG00313.667± 9.5975
OG00421.500± 17.2063
OG005-2.444± 7.1518
QTcF Interval
Title
Measurements
OG000-2.333± 13.5859
OG0011.583± 4.9319
OG002-2.611± 15.3122
OG0033.778± 11.4956
OG0046.667± 20.2704
OG005-4.111± 9.7144
4
OG0043
OG0054
4
ParticipantsOG0043
ParticipantsOG0054
Title
Measurements
OG00089.715(87.619 to 91.490)
OG00185.825(81.308 to 89.393)
OG00288.461(83.293 to 92.181)
OG00322.353(7.695 to 49.851)
OG0040.452(NA to NA)Free CCL17 values below the Lower limit of quantification (LLQ) are imputed to be (1/2) \*LLQ = 0.1. If more than 30% of values have been imputed at any timepoint for a treatment group, then CI has not been calculated due to the high proportion of non-quantifiable (NQ) values that have been imputed which may affect the CI values.
OG0050.863(NA to NA)Free CCL17 values below the Lower limit of quantification (LLQ) are imputed to be (1/2) \*LLQ = 0.1. If more than 30% of values have been imputed at any timepoint for a treatment group, then CI has not been calculated due to the high proportion of non-quantifiable (NQ) values that have been imputed which may affect the CI values.
Day 15, Percent change
ParticipantsOG0005
ParticipantsOG0017
ParticipantsOG0027
ParticipantsOG0034
ParticipantsOG0043
ParticipantsOG0054
Title
Measurements
OG00060.524(46.235 to 73.216)
OG00150.249(34.215 to 66.232)
OG00259.183(44.561 to 72.343)
OG003
Day 29, Percent change
ParticipantsOG0006
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0054
Title
Measurements
OG0000.529(NA to NA)Free CCL17 values below the Lower limit of quantification (LLQ) are imputed to be (1/2) \*LLQ = 0.1. If more than 30% of values have been imputed at any timepoint for a treatment group, then CI has not been calculated due to the high proportion of non-quantifiable (NQ) values that have been imputed which may affect the CI values.
OG0010.165(NA to NA)Free CCL17 values below the Lower limit of quantification (LLQ) are imputed to be (1/2) \*LLQ = 0.1. If more than 30% of values have been imputed at any timepoint for a treatment group, then CI has not been calculated due to the high proportion of non-quantifiable (NQ) values that have been imputed which may affect the CI values.
OG002
Day 57, Percent change
ParticipantsOG0006
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG0034
ParticipantsOG0043
ParticipantsOG0054
Title
Measurements
OG0001.380(NA to NA)Free CCL17 values below the Lower limit of quantification (LLQ) are imputed to be (1/2) \*LLQ = 0.1. If more than 30% of values have been imputed at any timepoint for a treatment group, then CI has not been calculated due to the high proportion of non-quantifiable (NQ) values that have been imputed which may affect the CI values.
OG0010.100(NA to NA)Free CCL17 values below the Lower limit of quantification (LLQ) are imputed to be (1/2) \*LLQ = 0.1. If more than 30% of values have been imputed at any timepoint for a treatment group, then CI has not been calculated due to the high proportion of non-quantifiable (NQ) values that have been imputed which may affect the CI values.
OG002
4
OG0043
OG0054
1661.847
± 31.284
OG004733.904± 4.084
OG005621.421± 61.396
4
OG0043
OG0054
57.000
± 75.7276
OG0041.083± 0.7217
OG00526.313± 38.8659
4
OG0043
OG0054
1.155
± 14.377
OG0041.270± 3.027
OG0051.383± 29.136
4
OG0043
OG0054
OG003
0.866
(0.689 to 1.089)
OG0040.975(0.750 to 1.268)
OG0051.025(0.730 to 1.439)
Day 15
Title
Measurements
OG00061.874(51.206 to 74.765)
OG001110.634(81.785 to 149.659)
OG00256.857(27.424 to 117.878)
OG0030.977(0.678 to 1.409)
OG0041.000(0.798 to 1.254)
OG0051.072(0.819 to 1.403)
Day 29
Title
Measurements
OG00026.405(22.124 to 31.515)
OG00161.250(46.002 to 81.552)
OG00221.448(9.707 to 47.388)
OG0030.971(0.495 to 1.904)
OG0040.960(0.881 to 1.046)
OG0051.145(0.858 to 1.528)
Day 57
Title
Measurements
OG0007.049(4.323 to 11.495)
OG00116.002(11.436 to 22.391)
OG0025.056(2.583 to 9.894)
OG0030.942(0.682 to 1.301)
OG0040.867(0.745 to 1.009)
OG0051.082(0.798 to 1.468)
4
OG0043
OG0054
0
OG0040
OG0050
4
OG0043
OG0054
0
OG0040
OG0050
-0.07
± 0.115
OG0040.03± 0.035
OG0050.68± 1.098
0.03
± 0.306
OG0040.15± 0.212
OG005-0.20± 0.361
-0.10
± 0.265
OG0040.05± 0.071
OG0050.10± 0.100
-0.97
± 1.079
OG0041.15± 1.061
OG0050.07± 0.462
7.528
(0.067 to 90.873)
OG0040.528(NA to NA)Free CCL17 values below the Lower limit of quantification (LLQ) are imputed to be (1/2) \*LLQ = 0.1. If more than 30% of values have been imputed at any timepoint for a treatment group, then CI has not been calculated due to the high proportion of non-quantifiable (NQ) values that have been imputed which may affect the CI values.
OG0050.787(NA to NA)Free CCL17 values below the Lower limit of quantification (LLQ) are imputed to be (1/2) \*LLQ = 0.1. If more than 30% of values have been imputed at any timepoint for a treatment group, then CI has not been calculated due to the high proportion of non-quantifiable (NQ) values that have been imputed which may affect the CI values.
0.606
(NA to NA)
Free CCL17 values below the Lower limit of quantification (LLQ) are imputed to be (1/2) \*LLQ = 0.1. If more than 30% of values have been imputed at any timepoint for a treatment group, then CI has not been calculated due to the high proportion of non-quantifiable (NQ) values that have been imputed which may affect the CI values.
OG0033.665(NA to NA)Free CCL17 values below the Lower limit of quantification (LLQ) are imputed to be (1/2) \*LLQ = 0.1. If more than 30% of values have been imputed at any timepoint for a treatment group, then CI has not been calculated due to the high proportion of non-quantifiable (NQ) values that have been imputed which may affect the CI values.
OG0040.316(NA to NA)Free CCL17 values below the Lower limit of quantification (LLQ) are imputed to be (1/2) \*LLQ = 0.1. If more than 30% of values have been imputed at any timepoint for a treatment group, then CI has not been calculated due to the high proportion of non-quantifiable (NQ) values that have been imputed which may affect the CI values.
OG0050.558(NA to NA)Free CCL17 values below the Lower limit of quantification (LLQ) are imputed to be (1/2) \*LLQ = 0.1. If more than 30% of values have been imputed at any timepoint for a treatment group, then CI has not been calculated due to the high proportion of non-quantifiable (NQ) values that have been imputed which may affect the CI values.
0.527
(NA to NA)
Free CCL17 values below the Lower limit of quantification (LLQ) are imputed to be (1/2) \*LLQ = 0.1. If more than 30% of values have been imputed at any timepoint for a treatment group, then CI has not been calculated due to the high proportion of non-quantifiable (NQ) values that have been imputed which may affect the CI values.
OG00314.136(1.811 to 59.507)
OG0041.416(NA to NA)Free CCL17 values below the Lower limit of quantification (LLQ) are imputed to be (1/2) \*LLQ = 0.1. If more than 30% of values have been imputed at any timepoint for a treatment group, then CI has not been calculated due to the high proportion of non-quantifiable (NQ) values that have been imputed which may affect the CI values.