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This is a first-in-human (FIH), randomized, placebo-controlled, double-blind, single ascending dose (SAD) study to assess the safety and tolerability of VIS954, a monoclonal antibody, in healthy adult male and female participants.
The study will be conducted in 6 sequential cohorts. Each cohort will enroll 9 participants, randomized to VIS954 or placebo at a ratio of 7:2.
On Day 1, a single dose of VIS954 or placebo will be administered SC. Sentinel participants will be utilized in each cohort. After 14 days, the safety data will be evaluated and a decision to admit and dose the next cohort will be made.
The total duration of the clinical study per participant will be up to 102 days (approximately 4 months).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VIS954 Dose 1 | Experimental | A single VIS954 Dose 1 will be administered subcutaneously on Day 1 |
|
| VIS954 Dose 2 | Experimental | A single VIS954 Dose 2 will be administered subcutaneously on Day 1 |
|
| VIS954 Dose 3 | Experimental | A single VIS954 Dose 3 will be administered subcutaneously on Day 1 |
|
| VIS954 Dose 4 | Experimental | A single VIS954 Dose 4 will be administered subcutaneously on Day 1 |
|
| VIS954 Dose 5 | Experimental | A single VIS954 Dose 5 will be administered subcutaneously on Day 1 |
|
| VIS954 Dose 6 | Experimental | A single VIS954 Dose 6 will be administered subcutaneously on Day 1 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIS954 | Biological | A humanized IgG4 monoclonal antibody. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) was any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via an authorized medicinal product or was an important medical event that jeopardized the participant or required medical or surgical intervention to prevent 1 of the other outcomes listed above. TEAEs were AEs that first occurred or worsened in severity after the study intervention administration, and up to Day 71 (including the follow-up period) after the study intervention administration. | From study intervention administration (Day 1) up to end of follow-up (Day 71) |
| Wong-Baker FACES Pain Rating Scale | The Wong-Baker FACES Pain Rating Scale was a subjective self-report that was used to record each participant's perception of pain associated with their injection. The scale ranged from 0 to 10 and showed a series of faces ranging from a happy face at 0 which represented "no hurt" to a crying face at 10 which represented "hurts worst." Based on the faces and descriptions, the participant recorded their level of pain. Higher scores indicated more severe pain. | Day 1 (1 and 4 hours post-dose), Day 2 (24 hours post-dose), and on Days 3 and 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Serum Concentration (Cmax) of VIS954 | Blood samples were collected for measurement of serum concentrations of VIS954 at the specified time points from Day 1 (within 2 hours pre-dose) to Day 71. The pharmacokinetic (PK) parameters of VIS954 were derived using noncompartmental analysis method. | Day 1 (within 2 hours pre-dose) and at multiple timepoints post-dose up to Day 71 |
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Inclusion Criteria:
Exclusion Criteria:
Participant has a history or current evidence of a serious and/or unstable cardiovascular, respiratory, gastrointestinal, hematologic, autoimmune, blood dyscrasias or other medical disorder, including psychiatric disorders, cirrhosis, or malignancy. History of minor skin cancers (not including melanoma) or surgically treated, limited cervical carcinomas (ie, carcinoma in situ) are not exclusionary.
Participant is participating in another clinical study of any investigational drug, device, or intervention or has received any investigational medication during the last 30 days or 5 half-lives, whichever is longer, before baseline (Day -1).
Previous receipt of antibody or biologic therapy.
History of a previous hypersensitivity or severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis to any of the ingredients of the VIS954 SC injection formulation.
Blood pressure > 160/100 mmHg or < 90/50 mmHg (may be repeated once if abnormal), at the screening visit or Day -1.
History of any infection requiring hospitalization or treatment with antivirals, antibiotics, or systemic antifungals within 3 months prior to screening.
Received a vaccination, other than COVID-19 vaccination, during the 30 days prior to administration of the first dose of study intervention. A COVID-19 vaccination cannot be received within 7 days prior to the first dose of study intervention and until 14 days after the last dose.
Has received any prescription or nonprescription (over-the-counter) medication during the last 30 days or 5 half-lives, whichever is longer, preceding baseline (Day -1), with the exception of acetaminophen, ibuprofen, naproxen (or other over-the-counter nonsteroidal anti-inflammatory drugs [NSAID]), hormonal contraceptives, topical medications, vitamins, and dietary or herbal remedies.
Any participant who has a recent history of alcohol or drug/chemical abuse, at the discretion of the investigator, will be excluded.
Enrolled participants must abstain from consumption of nicotine containing products from Day -1 through discharge.
Enrolled participants must abstain from consumption of cannabinoids from Day-1 through end of study.
For the duration of the study, enrolled male participants should not consume more than 15 standard drinks per week (7 days) and female participants should not consume more than 10 standard drinks per week (7 days). A standard drink equals 10 g of alcohol. Enrolled participants must abstain from consuming alcohol 48 hours prior to check-in on Day -1 through discharge.
Participant with a positive urine drug or alcohol breath screen test result at screening or Day -1. The urine drug screen and alcohol breath screen may be repeated once at the discretion of the investigator. The urine drug screen also screens for methylenedioxymethamphetamine and propoxyphene. If a participant tests positive on these tests, inclusion of that participant into the study will be based on the principal investigator's judgment with consultation, as needed, with the medical monitor and the sponsor.
Any chronic infectious disease (eg, chronic urinary tract infection, chronic sinusitis, bronchiectasis, active pulmonary or systemic tuberculosis [TB], chronic viral hepatitis such as hepatitis C or hepatitis B, or human immunodeficiency virus [HIV] infection).
Participant who has donated > 500 mL of blood within 60 days prior to start of the screening visit or the participant has donated any plasma within 7 days prior to baseline (Day -1).
Coronavirus disease 2019:
Is an employee of the clinical research team (any sponsor or research site employee), or has a family member who is an employee of these organizations.
Participant is judged by the investigator or the medical monitor to be inappropriate for the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Visterra Clinical Site | Anaheim | California | 92801 | United States |
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| Label | URL |
|---|---|
| Otsuka Clinical Trial Website | View source |
| Otsuka Clinical Trial Transparency | View source |
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The study was conducted in 6 sequential cohorts. In each cohort, participants were randomized in a 7:2 ratio to receive VIS954 or matching placebo. The study consisted of a screening period (up to 28 days before dosing), dosing on Day 1, a post-dose period (Days 5 to 57) and a final follow-up visit on Day 71. A total of 54 participants were enrolled in the study.
This Phase 1, double-blind, single ascending dose, first-in-human study was conducted in healthy participants at a single investigational site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: VIS954 Dose 1 | Participants received a single dose of VIS954 at Dose 1 via subcutaneous (SC) injection on Day 1. |
| FG001 | Cohort 2: VIS954 Dose 2 | Participants received a single dose of VIS954 at Dose 2 via SC injection on Day 1. |
| FG002 | Cohort 3: VIS954 Dose 3 | Participants received a single dose of VIS954 at Dose 3 via SC injection on Day 1. |
| FG003 | Cohort 4: VIS954 Dose 4 | Participants received a single dose of VIS954 at Dose 4 via SC injection on Day 1. |
| FG004 | Cohort 5: VIS954 Dose 5 | Participants received a single dose of VIS954 at Dose 5 via SC injection on Day 1. |
| FG005 | Cohort 6: VIS954 Dose 6 | Participants received a single dose of VIS954 at Dose 6 via SC injection on Day 1. |
| FG006 | Cohort 1 to 6: Pooled Placebo | Participants received a single dose of placebo matched to VIS954 via SC injection on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The safety analysis set included all participants who received trial intervention (active or placebo).
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: VIS954 Dose 1 | Participants received a single dose of VIS954 at Dose 1 via SC injection on Day 1. |
| BG001 | Cohort 2: VIS954 Dose 2 | Participants received a single dose of VIS954 at Dose 2 via SC injection on Day 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) was any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via an authorized medicinal product or was an important medical event that jeopardized the participant or required medical or surgical intervention to prevent 1 of the other outcomes listed above. TEAEs were AEs that first occurred or worsened in severity after the study intervention administration, and up to Day 71 (including the follow-up period) after the study intervention administration. | The safety analysis set included all participants who received trial intervention (active or placebo). | Posted | Count of Participants | Participants | No | From study intervention administration (Day 1) up to end of follow-up (Day 71) |
From study intervention administration (Day 1) up to end of follow-up (Day 71)
The safety analysis set included all participants who received trial intervention (active or placebo).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: VIS954 Dose 1 | Participants received a single dose of VIS954 at Dose 1 via SC injection on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood loss anaemia | Blood and lymphatic system disorders | MedDRA (27.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mohit Mathur, MD | Visterra, Inc. | +1-617-498-1070 | mmathur@visterrainc.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 20, 2023 | May 14, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 23, 2024 | May 14, 2025 | SAP_001.pdf |
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Phase 1, randomized, placebo-controlled, double-blind, single ascending dose study
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|
| Placebo | Placebo Comparator | A single Placebo dose will be administered subcutaneously on Day 1 for 2 participants in each cohort. |
|
| Placebo | Other | VIS954 Placebo |
|
| Time of Maximum Serum Concentration (Tmax) of VIS954 | Blood samples were collected for measurement of serum concentrations of VIS954 at the specified time points from Day 1 (within 2 hours pre-dose) to Day 71. The PK parameters of VIS954 were derived using noncompartmental analysis method. | Day 1 (within 2 hours pre-dose) and at multiple timepoints post-dose up to Day 71 |
| Area Under the Concentration-Time Curve From Pre-dose Extrapolated to Infinite Time (AUC0-inf) of VIS954 | Blood samples were collected for measurement of serum concentrations of VIS954 at the specified time points from Day 1 (within 2 hours pre-dose) to Day 71. The PK parameters of VIS954 were derived using noncompartmental analysis method. | Day 1 (within 2 hours pre-dose) and at multiple timepoints post-dose up to Day 71 |
| Area Under the Concentration-Time Curve From Pre-dose to the Last Quantifiable Concentration (AUC0-last) of VIS954 | Blood samples were collected for measurement of serum concentrations of VIS954 at the specified time points from Day 1 (within 2 hours pre-dose) to Day 71. The PK parameters of VIS954 were derived using noncompartmental analysis method. | Day 1 (within 2 hours pre-dose) and at multiple timepoints post-dose up to Day 71 |
| Apparent Terminal Elimination Half-Life (t1/2) of VIS954 | Blood samples were collected for measurement of serum concentrations of VIS954 at the specified time points from Day 1 (within 2 hours pre-dose) to Day 71. The PK parameters of VIS954 were derived using noncompartmental analysis method. | Day 1 (within 2 hours pre-dose) and at multiple timepoints post-dose up to Day 71 |
| Apparent Volume of Distribution (Vd/F) of VIS954 | Blood samples were collected for measurement of serum concentrations of VIS954 at the specified time points from Day 1 (within 2 hours pre-dose) to Day 71. The PK parameters of VIS954 were derived using noncompartmental analysis method. | Day 1 (within 2 hours pre-dose) and at multiple timepoints post-dose up to Day 71 |
| Apparent Clearance After Extravascular Dosing (CL/F) of VIS954 | Blood samples were collected for measurement of serum concentrations of VIS954 at the specified time points from Day 1 (within 2 hours pre-dose) to Day 71. The PK parameters of VIS954 were derived using noncompartmental analysis method. | Day 1 (within 2 hours pre-dose) and at multiple timepoints post-dose up to Day 71 |
| Time Spent Above 40 Percentage Receptor Occupancy (RO) for Neutrophils | Blood samples were collected at the specified time points to characterize the effect of VIS954 binding. The time spent above 40% RO was defined as duration in hours from date and time of dosing until the date and time of pharmacodynamic (PD) collection when %RO >40%. Baseline was defined as the last non-missing measurement taken prior to reference start date (including unscheduled assessments). | Baseline (Day -1) up to Day 71 |
| BG002 | Cohort 3: VIS954 Dose 3 | Participants received a single dose of VIS954 at Dose 3 via SC injection on Day 1. |
| BG003 | Cohort 4: VIS954 Dose 4 | Participants received a single dose of VIS954 at Dose 4 via SC injection on Day 1. |
| BG004 | Cohort 5: VIS954 Dose 5 | Participants received a single dose of VIS954 at Dose 5 via SC injection on Day 1. |
| BG005 | Cohort 6: VIS954 Dose 6 | Participants received a single dose of VIS954 at Dose 6 via SC injection on Day 1. |
| BG006 | Cohort 1 to 6: Pooled Placebo | Participants received a single dose of placebo matched to VIS954 via SC injection on Day 1. |
| BG007 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Cohort 1: VIS954 Dose 1 | Participants received a single dose of VIS954 at Dose 1 via SC injection on Day 1. |
| OG001 | Cohort 2: VIS954 Dose 2 | Participants received a single dose of VIS954 at Dose 2 via SC injection on Day 1. |
| OG002 | Cohort 3: VIS954 Dose 3 | Participants received a single dose of VIS954 at Dose 3 via SC injection on Day 1. |
| OG003 | Cohort 4: VIS954 Dose 4 | Participants received a single dose of VIS954 at Dose 4 via SC injection on Day 1. |
| OG004 | Cohort 5: VIS954 Dose 5 | Participants received a single dose of VIS954 at Dose 5 via SC injection on Day 1. |
| OG005 | Cohort 6: VIS954 Dose 6 | Participants received a single dose of VIS954 at Dose 6 via SC injection on Day 1. |
| OG006 | Cohort 1 to 6: Pooled Placebo | Participants received a single dose of placebo matched to VIS954 via SC injection on Day 1. |
|
|
| Primary | Wong-Baker FACES Pain Rating Scale | The Wong-Baker FACES Pain Rating Scale was a subjective self-report that was used to record each participant's perception of pain associated with their injection. The scale ranged from 0 to 10 and showed a series of faces ranging from a happy face at 0 which represented "no hurt" to a crying face at 10 which represented "hurts worst." Based on the faces and descriptions, the participant recorded their level of pain. Higher scores indicated more severe pain. | The safety analysis set included all participants who received trial intervention (active or placebo). | Posted | Mean | Standard Deviation | units on a scale | Day 1 (1 and 4 hours post-dose), Day 2 (24 hours post-dose), and on Days 3 and 29 |
|
|
|
| Secondary | Maximum Serum Concentration (Cmax) of VIS954 | Blood samples were collected for measurement of serum concentrations of VIS954 at the specified time points from Day 1 (within 2 hours pre-dose) to Day 71. The pharmacokinetic (PK) parameters of VIS954 were derived using noncompartmental analysis method. | PK analysis set: participants who received VIS954 and had at least 1 measured post-dose VIS954 serum concentration at scheduled PK time after start of dosing for at least 1 PK analyte without protocol deviations/events with potential to affect evaluation of PK data. As pre-specified in SAP, 13 participants (7 and 6 in Cohorts 1 and 2) were excluded from PK analysis as PK profiles were below limit of quantitation (BLQ). Only participants with data collected at specified timepoints are reported. | Posted | Mean | Standard Deviation | micrograms per milliliter (mcg/mL) | Day 1 (within 2 hours pre-dose) and at multiple timepoints post-dose up to Day 71 |
|
|
|
| Secondary | Time of Maximum Serum Concentration (Tmax) of VIS954 | Blood samples were collected for measurement of serum concentrations of VIS954 at the specified time points from Day 1 (within 2 hours pre-dose) to Day 71. The PK parameters of VIS954 were derived using noncompartmental analysis method. | The PK analysis set included all participants who received VIS954 and had at least 1 measured post-dose VIS954 serum concentration at scheduled PK time after start of dosing for at least 1 PK analyte without protocol deviations or events with potential to affect the evaluation of the PK data. As pre-specified in SAP, 13 participants (7 and 6 in Cohorts 1 and 2) were excluded from PK analysis as PK profiles were BLQ. Only participants with data collected at specified timepoints are reported. | Posted | Median | Full Range | hour | Day 1 (within 2 hours pre-dose) and at multiple timepoints post-dose up to Day 71 |
|
|
|
| Secondary | Area Under the Concentration-Time Curve From Pre-dose Extrapolated to Infinite Time (AUC0-inf) of VIS954 | Blood samples were collected for measurement of serum concentrations of VIS954 at the specified time points from Day 1 (within 2 hours pre-dose) to Day 71. The PK parameters of VIS954 were derived using noncompartmental analysis method. | The PK analysis set included all participants who received VIS954 and had at least 1 measured post-dose VIS954 serum concentration at scheduled PK time after start of dosing for at least 1 PK analyte without protocol deviations or events with potential to affect the evaluation of the PK data. As pre-specified in SAP, 13 participants (7 and 6 in Cohorts 1 and 2) were excluded from PK analysis as PK profiles were BLQ. Only participants with data collected at specified timepoints are reported. | Posted | Mean | Standard Deviation | hour*mcg/mL | Day 1 (within 2 hours pre-dose) and at multiple timepoints post-dose up to Day 71 |
|
|
|
| Secondary | Area Under the Concentration-Time Curve From Pre-dose to the Last Quantifiable Concentration (AUC0-last) of VIS954 | Blood samples were collected for measurement of serum concentrations of VIS954 at the specified time points from Day 1 (within 2 hours pre-dose) to Day 71. The PK parameters of VIS954 were derived using noncompartmental analysis method. | The PK analysis set included all participants who received VIS954 and had at least 1 measured post-dose VIS954 serum concentration at scheduled PK time after start of dosing for at least 1 PK analyte without protocol deviations or events with potential to affect the evaluation of the PK data. As pre-specified in SAP, 13 participants (7 and 6 in Cohorts 1 and 2) were excluded from PK analysis as PK profiles were BLQ. Only participants with data collected at specified timepoints are reported. | Posted | Mean | Standard Deviation | hour*mcg/mL | Day 1 (within 2 hours pre-dose) and at multiple timepoints post-dose up to Day 71 |
|
|
|
| Secondary | Apparent Terminal Elimination Half-Life (t1/2) of VIS954 | Blood samples were collected for measurement of serum concentrations of VIS954 at the specified time points from Day 1 (within 2 hours pre-dose) to Day 71. The PK parameters of VIS954 were derived using noncompartmental analysis method. | The PK analysis set included all participants who received VIS954 and had at least 1 measured post-dose VIS954 serum concentration at scheduled PK time after start of dosing for at least 1 PK analyte without protocol deviations or events with potential to affect the evaluation of the PK data. As pre-specified in SAP, 13 participants (7 and 6 in Cohorts 1 and 2) were excluded from PK analysis as PK profiles were BLQ. Only participants with data collected at specified timepoints are reported. | Posted | Median | Full Range | hour | Day 1 (within 2 hours pre-dose) and at multiple timepoints post-dose up to Day 71 |
|
|
|
| Secondary | Apparent Volume of Distribution (Vd/F) of VIS954 | Blood samples were collected for measurement of serum concentrations of VIS954 at the specified time points from Day 1 (within 2 hours pre-dose) to Day 71. The PK parameters of VIS954 were derived using noncompartmental analysis method. | The PK analysis set included all participants who received VIS954 and had at least 1 measured post-dose VIS954 serum concentration at scheduled PK time after start of dosing for at least 1 PK analyte without protocol deviations or events with potential to affect the evaluation of the PK data. As pre-specified in SAP, 13 participants (7 and 6 in Cohorts 1 and 2) were excluded from PK analysis as PK profiles were BLQ. Only participants with data collected at specified timepoints are reported. | Posted | Mean | Standard Deviation | liter | Day 1 (within 2 hours pre-dose) and at multiple timepoints post-dose up to Day 71 |
|
|
|
| Secondary | Apparent Clearance After Extravascular Dosing (CL/F) of VIS954 | Blood samples were collected for measurement of serum concentrations of VIS954 at the specified time points from Day 1 (within 2 hours pre-dose) to Day 71. The PK parameters of VIS954 were derived using noncompartmental analysis method. | The PK analysis set included all participants who received VIS954 and had at least 1 measured post-dose VIS954 serum concentration at scheduled PK time after start of dosing for at least 1 PK analyte without protocol deviations or events with potential to affect the evaluation of the PK data. As pre-specified in SAP, 13 participants (7 and 6 in Cohorts 1 and 2) were excluded from PK analysis as PK profiles were BLQ. Only participants with data collected at specified timepoints are reported. | Posted | Mean | Standard Deviation | liter per hour | Day 1 (within 2 hours pre-dose) and at multiple timepoints post-dose up to Day 71 |
|
|
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| Secondary | Time Spent Above 40 Percentage Receptor Occupancy (RO) for Neutrophils | Blood samples were collected at the specified time points to characterize the effect of VIS954 binding. The time spent above 40% RO was defined as duration in hours from date and time of dosing until the date and time of pharmacodynamic (PD) collection when %RO >40%. Baseline was defined as the last non-missing measurement taken prior to reference start date (including unscheduled assessments). | The PD analysis set included all participants who received trial intervention (active or placebo) and had at least 1 measured PD value at a scheduled time point after start of dosing. | Posted | Median | Full Range | hour | Baseline (Day -1) up to Day 71 |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 2 |
| 7 |
| EG001 | Cohort 2: VIS954 Dose 2 | Participants received a single dose of VIS954 at Dose 2 via SC injection on Day 1. | 0 | 7 | 0 | 7 | 1 | 7 |
| EG002 | Cohort 3: VIS954 Dose 3 | Participants received a single dose of VIS954 at Dose 3 via SC injection on Day 1. | 0 | 7 | 0 | 7 | 1 | 7 |
| EG003 | Cohort 4: VIS954 Dose 4 | Participants received a single dose of VIS954 at Dose 4 via SC injection on Day 1. | 0 | 7 | 0 | 7 | 1 | 7 |
| EG004 | Cohort 5: VIS954 Dose 5 | Participants received a single dose of VIS954 at Dose 5 via SC injection on Day 1. | 0 | 7 | 0 | 7 | 3 | 7 |
| EG005 | Cohort 6: VIS954 Dose 6 | Participants received a single dose of VIS954 at Dose 6 via SC injection on Day 1. | 0 | 7 | 0 | 7 | 2 | 7 |
| EG006 | Cohort 1 to 6: Pooled Placebo | Participants received a single dose of placebo matched to VIS954 via SC injection on Day 1. | 0 | 12 | 0 | 12 | 4 | 12 |
| Diarrhoea | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA (27.0) | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA (27.0) | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA (27.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
|
Not provided
Not provided
| Day 1: 4 hours post-dose |
|
| Day 2: 24 hours post-dose |
|
| Day 3 |
|
| Day 29 |
|