Assessment of KAN-101 in Celiac Disease (ACeD) | NCT04248855 | Trialant
NCT04248855
Sponsor
Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA
Status
Completed
Last Update Posted
Aug 6, 2024Actual
Enrollment
41Actual
Phase
Phase 1
Conditions
Celiac Disease
Interventions
KAN-101
Placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT04248855
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
KAN-101-01
Secondary IDs
Not provided
Brief Title
Assessment of KAN-101 in Celiac Disease (ACeD)
Official Title
A Phase 1 Study of the Safety and Tolerability of Single and Multiple Doses of KAN-101 in Patients With Celiac Disease (ACeD)
Acronym
Not provided
Organization
Anokion SAINDUSTRY
Status Module
Record Verification Date
Aug 2024
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
Jan 21, 2020Actual
Primary Completion Date
Oct 8, 2021Actual
Completion Date
Oct 8, 2021Actual
First Submitted Date
Jan 28, 2020
First Submission Date that Met QC Criteria
Jan 29, 2020
First Posted Date
Jan 30, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Oct 4, 2022
Results First Submitted that Met QC Criteria
Sep 14, 2023
Results First Posted Date
Mar 21, 2024Actual
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
Aug 2, 2024
Last Update Posted Date
Aug 6, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SAINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
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
A safety study of KAN-101 in patients with celiac disease. The study has two parts:
Part A - first in human study in which patients receive a single dose of KAN-101
Part B - patients will receive three doses of either KAN-101 or placebo
Detailed Description
Study KAN-101-01 is a Phase 1, FIH study designed to evaluate the safety and tolerability of KAN-101 in patients with celiac disease on a gluten free diet (GFD).
An overview of the two parts and proposed dose groups is given below:
Part A (SAD): Patients will receive a single dose of KAN-101.
Part B (MAD): Patients will receive three doses of either KAN-101 or placebo.
Conditions Module
Conditions
Celiac Disease
Keywords
Phase 1
Double blind
Multicenter
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
41Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
SAD Cohort 1
Experimental
All enrolled patients will receive one dose of KAN-101 Dose A
Drug: KAN-101
SAD Cohort 2
Experimental
All enrolled patients will receive one dose of KAN-101 Dose B
Drug: KAN-101
SAD Cohort 3
Experimental
All enrolled patients will receive one dose of KAN-101 Dose C
Drug: KAN-101
SAD Cohort 4
Experimental
All enrolled patients will receive one dose of KAN-101 Dose D
Drug: KAN-101
MAD Cohort 5
Experimental
All randomized patients will receive 3 doses of either KAN-101 Dose A or placebo
Drug: KAN-101
Drug: Placebo
MAD Cohort 6
Experimental
All randomized patients will receive 3 doses of either KAN-101 Dose B or placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
KAN-101
Drug
Intravenous (IV) infusion
MAD Cohort 5
MAD Cohort 6
MAD Cohort 7
SAD Cohort 1
SAD Cohort 2
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Incidence and Severity of Treatment-emergent Adverse Events (TEAEs)
Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or higher
Up to 28 Days
Secondary Outcomes
Measure
Description
Time Frame
Cmax
Geometric mean of maximum drug concentration (Cmax)
0, 7, 15, 30, 60, 120, 180, 240, 300, 360 minutes post dose on Days 1 and and 7
AUC Last
Area under the plasma concentration-time curve from time 0 to the last measurable time point (AUC last)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Adults aged 18 to 70 years inclusive
Diagnosed with celiac disease based on positive serology (eg, tissue transglutaminase IgA antibody and/or deamidated gliadin peptide IgG) and intestinal histology consistent with ≥ Marsh Type II or with evidence of villous atrophy
Has HLA-DQ2.5 genotype (HLA-DQA1*05 and HLA-DQB1*02) (homozygotes or heterozygotes)
Has followed a GFD for > 12 months immediately prior to study entry
Negative or weak positive for tTG-IgA and negative or weak positive for DGP-IgA/IgG during screening
Male or female. Females of childbearing potential must use at least 2 acceptable birth control methods
Capable of understanding and complying with protocol requirements
Patient understands and has signed the informed consent form
Key Exclusion Criteria:
Refractory celiac disease
Selective IgA deficiency
Positive for HLA-DQ8 (DQA1*03, DQB1*0302)
Previous treatment with tolerance-inducing therapies for celiac disease
Known wheat allergy
Part B only: History of hyperacute or prolonged symptoms following gluten exposure
Uncontrolled or significant medical conditions (including active infections or chronic hepatitis) which, in the opinion of the Investigator, preclude participation
Murray JA, Wassaf D, Dunn K, Arora S, Winkle P, Stacey H, Cooper S, Goldstein KE, Manchanda R, Kontos S, Grebe KM. Safety and tolerability of KAN-101, a liver-targeted immune tolerance therapy, in patients with coeliac disease (ACeD): a phase 1 trial. Lancet Gastroenterol Hepatol. 2023 Aug;8(8):735-747. doi: 10.1016/S2468-1253(23)00107-3. Epub 2023 Jun 14.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
SAD 0.15mg/kg
All enrolled patients received one dose of 0.15mg/kg KAN-101
KAN-101: Intravenous (IV) infusion
FG001
SAD 0.3mg/kg
All enrolled patients received one dose of 0.3mg/kg KAN-101
KAN-101: Intravenous (IV) infusion
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Mar 29, 2021
Oct 4, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Drug: KAN-101
Drug: Placebo
MAD Cohort 7
Experimental
All randomized patients will receive 3 doses of either KAN-101 Dose C or placebo
Drug: KAN-101
Drug: Placebo
SAD Cohort 3
SAD Cohort 4
Placebo
Drug
Intravenous (IV) infusion
MAD Cohort 5
MAD Cohort 6
MAD Cohort 7
0, 7, 15, 30, 60, 120, 180, 240, 300, 360 minutes post dose on Days 1 and and 7
Walnut Creek
California
94598
United States
Innovative Medical Research of South Florida
Aventura
Florida
33180
United States
GCP Research
St. Petersburg
Florida
33705
United States
Tandem Clinical Research
Marrero
Louisiana
70072
United States
Parexel International- EPCU Baltimore
Baltimore
Maryland
21225
United States
West Michigan Clinical Research Center
Wyoming
Michigan
49519
United States
Mayo Clinic
Rochester
Minnesota
55905
United States
Celiac Disease Center at Columbia University
New York
New York
10032
United States
North Carolina Clinical Research
Raleigh
North Carolina
27607
United States
Aventiv Research
Columbus
Ohio
43213
United States
WR-ClinSearch, LLC
Chattanooga
Tennessee
37421
United States
Advanced Clinical Research
West Jordan
Utah
84088
United States
FG002
SAD 0.6mg/kg
All enrolled patients received one dose of 0.6mg/kg KAN-101
KAN-101: Intravenous (IV) infusion
FG003
SAD 1.2mg/kg
All enrolled patients received one dose of 1.2mg/kg KAN-101
KAN-101: Intravenous (IV) infusion
FG004
SAD 1.5mg/kg
All enrolled patients received one dose of 1.5mg/kg KAN-101
KAN-101: Intravenous (IV) infusion
FG005
MAD 0.15mg/kg
All randomized patients received 3 doses of 0.15mg/kg KAN-101
KAN-101: Intravenous (IV) infusion
FG006
MAD 0.3mg/kg
All randomized patients received 3 doses of 0.3mg/kg KAN-101
KAN-101: Intravenous (IV) infusion
FG007
MAD 0.6mg/kg
All randomized patients received 3 doses of 0.6mg/kg KAN-101
KAN-101: Intravenous (IV) infusion
FG008
MAD Placebo
All randomized patients received 3 doses of placebo
Placebo: Intravenous (IV) infusion
FG0004 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG0041 subjects
FG0056 subjects
FG0067 subjects
FG0078 subjects
FG0086 subjects
COMPLETED
FG0004 subjects
FG0013 subjects
FG0023 subjects
FG0033 subjects
FG0041 subjects
FG0056 subjects
FG0066 subjects
FG0077 subjects
FG0086 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0071 subjects
FG0080 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
SAD 0.15mg/kg
All enrolled patients will receive one dose of 0.15mg/kg KAN-101
KAN-101: Intravenous (IV) infusion
BG001
SAD 0.3mg/kg
All enrolled patients will receive one dose of 0.3mg/kg KAN-101
KAN-101: Intravenous (IV) infusion
BG002
SAD 0.6mg/kg
All enrolled patients will receive one dose of 0.6mg/kg KAN-101
KAN-101: Intravenous (IV) infusion
BG003
SAD 1.2mg/kg
All enrolled patients will receive one dose of 1.2mg/kg KAN-101
KAN-101: Intravenous (IV) infusion
BG004
SAD 1.5mg/kg
All enrolled patients will receive one dose of 1.5mg/kg KAN-101
KAN-101: Intravenous (IV) infusion
BG005
MAD 0.15mg/kg
All randomized patients will receive 3 doses of 0.15mg/kg KAN-101
KAN-101: Intravenous (IV) infusion
BG006
MAD 0.3mg/kg
All randomized patients will receive 3 doses of 0.3mg/kg KAN-101
KAN-101: Intravenous (IV) infusion
BG007
MAD 0.6mg/kg
All randomized patients will receive 3 doses of 0.6mg/kg KAN-101
KAN-101: Intravenous (IV) infusion
BG008
MAD Placebo
All randomized patients will receive 3 doses of placebo
Placebo: Intravenous (IV) infusion
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0004
BG0013
BG0023
BG0033
BG0041
BG0056
BG0067
BG0078
BG0086
BG00941
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00047.8± 19.05
BG00130.3± 15.72
BG00235.3± 9.29
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0004
BG0013
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG0004
BG0013
BG002
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
Incidence and Severity of Treatment-emergent Adverse Events (TEAEs)
Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or higher
All patients who received any amount of study drug with treatment group based on the dose level received.
Posted
Count of Participants
Participants
Up to 28 Days
ID
Title
Description
OG000
SAD 0.15mg/kg
All enrolled patients received one dose of 0.15mg/kg KAN-101
KAN-101: Intravenous (IV) infusion
OG001
SAD 0.3mg/kg
All enrolled patients received one dose of 0.3mg/kg KAN-101
KAN-101: Intravenous (IV) infusion
OG002
SAD 0.6mg/kg
All enrolled patients received one dose of 0.6mg/kg KAN-101
KAN-101: Intravenous (IV) infusion
OG003
SAD 1.2mg/kg
All enrolled patients received one dose of 1.2mg/kg KAN-101
KAN-101: Intravenous (IV) infusion
OG004
SAD 1.5mg/kg
All enrolled patients will receive one dose of 1.5mg/kg KAN-101
KAN-101: Intravenous (IV) infusion
OG005
MAD 0.15mg/kg
All randomized patients received 3 doses of 0.15mg/kg KAN-101
KAN-101: Intravenous (IV) infusion
OG006
MAD 0.3mg/kg
All randomized patients received 3 doses of 0.3mg/kg KAN-101
KAN-101: Intravenous (IV) infusion
OG007
MAD 0.6mg/kg
All randomized patients received 3 doses of 0.6mg/kg KAN-101
KAN-101: Intravenous (IV) infusion
OG008
MAD Placebo
All randomized patients received 3 doses of placebo
Placebo: Intravenous (IV) infusion
Units
Counts
Participants
OG0004
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
TEAE
OG0004
OG0013
OG0022
OG003
Secondary
Cmax
Geometric mean of maximum drug concentration (Cmax)
All patients who received at least 1 dose of KAN-101 and have at least 1 drug concentration value. A patient may have been excluded from summary statistics due to insufficient data or failure to meet acceptability criteria
Posted
Geometric Mean
Standard Deviation
ng/mL
0, 7, 15, 30, 60, 120, 180, 240, 300, 360 minutes post dose on Days 1 and and 7
ID
Title
Description
OG000
SAD 0.15mg/kg
All enrolled patients received one dose of 0.15mg/kg KAN-101
KAN-101: Intravenous (IV) infusion
OG001
SAD 0.3mg/kg
All enrolled patients received one dose of 0.3mg/kg KAN-101
KAN-101: Intravenous (IV) infusion
OG002
SAD 0.6mg/kg
All enrolled patients received one dose of 0.6mg/kg KAN-101
KAN-101: Intravenous (IV) infusion
OG003
SAD 1.2mg/kg
All enrolled patients received one dose of 1.2mg/kg KAN-101
KAN-101: Intravenous (IV) infusion
Secondary
AUC Last
Area under the plasma concentration-time curve from time 0 to the last measurable time point (AUC last)
All patients who received at least 1 dose of KAN-101 and have at least 1 drug concentration value. A patient may have been excluded from summary statistics due to insufficient data or failure to meet acceptability criteria
Posted
Geometric Mean
Standard Deviation
h*ng/mL
0, 7, 15, 30, 60, 120, 180, 240, 300, 360 minutes post dose on Days 1 and and 7
ID
Title
Description
OG000
SAD 0.15mg/kg
All enrolled patients received one dose of 0.15mg/kg KAN-101
KAN-101: Intravenous (IV) infusion
OG001
SAD 0.3mg/kg
All enrolled patients received one dose of 0.3mg/kg KAN-101
KAN-101: Intravenous (IV) infusion
OG002
SAD 0.6mg/kg
All enrolled patients received one dose of 0.6mg/kg KAN-101
KAN-101: Intravenous (IV) infusion
OG003
SAD 1.2mg/kg
All enrolled patients received one dose of 1.2mg/kg KAN-101
KAN-101: Intravenous (IV) infusion
Time Frame
Up to 28 Days
Description
Not provided
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
SAD 0.15mg/kg
All enrolled patients received one dose of 0.15mg/kg KAN-101
KAN-101: Intravenous (IV) infusion
0
4
0
4
4
4
EG001
SAD 0.3mg/kg
All enrolled patients received one dose of 0.3mg/kg KAN-101
KAN-101: Intravenous (IV) infusion
0
3
0
3
3
3
EG002
SAD 0.6mg/kg
All enrolled patients received one dose of 0.6mg/kg KAN-101
KAN-101: Intravenous (IV) infusion
0
3
0
3
2
3
EG003
SAD 1.2mg/kg
All enrolled patients received one dose of 1.2mg/kg KAN-101
KAN-101: Intravenous (IV) infusion
0
3
0
3
3
3
EG004
SAD 1.5mg/kg
All enrolled patients received one dose of 1.5mg/kg KAN-101
KAN-101: Intravenous (IV) infusion
0
1
0
1
1
1
EG005
MAD 0.15mg/kg
All randomized patients received 3 doses of 0.15mg/kg KAN-101
KAN-101: Intravenous (IV) infusion
0
6
0
6
6
6
EG006
MAD 0.3mg/kg
All randomized patients received 3 doses of 0.3mg/kg KAN-101
KAN-101: Intravenous (IV) infusion
0
7
0
7
5
7
EG007
MAD 0.6mg/kg
All randomized patients received 3 doses of 0.6mg/kg KAN-101
KAN-101: Intravenous (IV) infusion
0
8
0
8
7
8
EG008
MAD Placebo
All randomized patients received 3 doses of placebo
Placebo: Intravenous (IV) infusion
0
6
0
6
4
6
Serious Adverse Events
Not provided
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nausea
Gastrointestinal disorders
MedDRA (24)
Systematic Assessment
Treatment-Emergent Adverse Events Related to Investigational Medicinal
EG0002 events2 affected4 at risk
EG0011 events1 affected3 at risk
EG0022 events2 affected3 at risk
EG0032 events2 affected3 at risk
Diarrhea
Gastrointestinal disorders
MedDRA (24)
Systematic Assessment
Treatment-Emergent Adverse Events Related to Investigational Medicinal
EG0002 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (24)
Systematic Assessment
Treatment-Emergent Adverse Events Related to Investigational Medicinal
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal Distension
Gastrointestinal disorders
MedDRA (24)
Systematic Assessment
Treatment-Emergent Adverse Events Related to Investigational Medicinal
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA (24)
Systematic Assessment
Treatment-Emergent Adverse Events Related to Investigational Medicinal
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0022 events2 affected3 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDRA (24)
Systematic Assessment
Treatment-Emergent Adverse Events Related to Investigational Medicinal
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA (24)
Systematic Assessment
Treatment-Emergent Adverse Events Related to Investigational Medicinal
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (24)
Systematic Assessment
Treatment-Emergent Adverse Events Related to Investigational Medicinal
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG003
Eructation
Gastrointestinal disorders
MedDRA (24)
Systematic Assessment
Treatment-Emergent Adverse Events Related to Investigational Medicinal
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Retching
Gastrointestinal disorders
MedDRA (24)
Systematic Assessment
Treatment-Emergent Adverse Events Related to Investigational Medicinal
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA (24)
Systematic Assessment
Treatment-Emergent Adverse Events Related to Investigational Medicinal
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (24)
Systematic Assessment
Treatment-Emergent Adverse Events Related to Investigational Medicinal
EG0002 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Fatigue
General disorders
MedDRA (24)
Systematic Assessment
Treatment-Emergent Adverse Events Related to Investigational Medicinal
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Asthenia
General disorders
MedDRA (24)
Systematic Assessment
Treatment-Emergent Adverse Events Related to Investigational Medicinal
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Chills
General disorders
MedDRA (24)
Systematic Assessment
Treatment-Emergent Adverse Events Related to Investigational Medicinal
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Feeling Cold
General disorders
MedDRA (24)
Systematic Assessment
Treatment-Emergent Adverse Events Related to Investigational Medicinal
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pain
General disorders
MedDRA (24)
Systematic Assessment
Treatment-Emergent Adverse Events Related to Investigational Medicinal
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA (24)
Systematic Assessment
Treatment-Emergent Adverse Events Related to Investigational Medicinal
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (24)
Systematic Assessment
Treatment-Emergent Adverse Events Related to Investigational Medicinal
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Cold Sweat
Skin and subcutaneous tissue disorders
MedDRA (24)
Systematic Assessment
Treatment-Emergent Adverse Events Related to Investigational Medicinal
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Flushing
Vascular disorders
MedDRA (24)
Systematic Assessment
Treatment-Emergent Adverse Events Related to Investigational Medicinal
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA (24)
Systematic Assessment
Treatment-Emergent Adverse Events Related to Investigational Medicinal
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal Tenderness
Gastrointestinal disorders
MedDRA (24)
Systematic Assessment
Treatment-Emergent Adverse Events Related to Investigational Medicinal
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Aphthous Ulcer
Gastrointestinal disorders
MedDRA (24)
Systematic Assessment
Treatment-Emergent Adverse Events Related to Investigational Medicinal
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Frequent Bowel Movements
Gastrointestinal disorders
MedDRA (24)
Systematic Assessment
Treatment-Emergent Adverse Events Related to Investigational Medicinal
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Steatorrhea
Gastrointestinal disorders
MedDRA (24)
Systematic Assessment
Treatment-Emergent Adverse Events Related to Investigational Medicinal
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Feeling Hot
General disorders
MedDRA (24)
Systematic Assessment
Treatment-Emergent Adverse Events Related to Investigational Medicinal
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Peripheral Swelling
General disorders
MedDRA (24)
Systematic Assessment
Treatment-Emergent Adverse Events Related to Investigational Medicinal
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Eye Pain
Eye disorders
MedDRA (24)
Systematic Assessment
Treatment-Emergent Adverse Events Related to Investigational Medicinal
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Not provided
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Medical Director
Kanyos Bio (A wholly owned subsidiary of Anokion SA)