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The purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of multiple doses of VIS954 compared with placebo in healthy adult participants.
The study will be conducted in 3 sequential cohorts. Each cohort will enroll 8 participants, randomized to VIS954 or placebo at a ratio of 6:2.
In each cohort, participants will be administered 6 doses of VIS954 or placebo with a dosing frequency of once every 2 weeks (Q2W). A Safety Monitoring Committee (SMC) will review the data and approve escalation to the next planned dose level.
The total duration of the clinical trial for each participant will be up to approximately 7 months, including the screening period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VIS954 - Low Dose | Experimental | VIS954 Low Dose will be administered subcutaneously on Days 1, 15, 29, 43, 57, and 71 |
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| VIS954 - Medium Dose | Experimental | VIS954 Medium Dose will be administered subcutaneously on Days 1, 15, 29, 43, 57, and 71 |
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| VIS954 - High Dose | Experimental | VIS954 High Dose will be administered subcutaneously on Days 1, 15, 29, 43, 57, and 71 |
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| Placebo | Placebo Comparator | Placebo will be administered subcutaneously on Days 1, 15, 29, 43, 57, and 71 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIS954 | Drug | A humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb) |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) | Number and Percentage of Adverse Events (AEs) that first occurred or worsened in severity after the study intervention administration. | 169 days |
| Maximum serum concentration after administration of VIS954 over time | Blood samples will be collected for measurement of serum concentrations of VIS954 at specified time points to assess maximum serum concentration over time | 169 days |
| Area under the concentration-time curve from time zero extrapolated to time t | Blood samples will be collected for measurement of serum concentrations of VIS954 at specified time points to assess area under the concentration-time curve from time zero extrapolated to time t (AUC 0-t) | 169 days |
| Measure | Description | Time Frame |
|---|---|---|
| VIS954 Percentage Receptor Occupancy | Pharmacodynamic parameter to characterize and evaluate VIS954 binding to target receptor | 169 days |
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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 treated, limited cervical carcinomas (ie, carcinoma in situ) are not exclusionary.
Participant is participating in another clinical trial 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.
Receipt of blood products within 6 months prior to screening.
History of a previous hypersensitivity or severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis to any of the ingredients of the VIS954 subcutaneous (SC) injection formulation.
Previous exposure to VIS954.
Blood pressure > 140/90 mmHg or < 90/60 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 Coronavirus Disease 2019 (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.
For the duration of the trial, 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 each administration of study intervention.
Enrolled participants must abstain from consumption of nicotine containing products from Day-1 through discharge from the trial site clinic (Day 3).
Enrolled participants must abstain from consumption of cannabinoids from Day-1 through end of trial.
Participant with a positive urine drug and alcohol screen test result at screening or baseline. The urine drug and alcohol screen may be repeated once at the discretion of the investigator. The urine drug screen includes screening for cannabinoids, methylenedioxymethamphetamine, and propoxyphene. If a participant tests positive on these tests, inclusion of that participant into the trial 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 (COVID-19):
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 trial.
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| Name | Affiliation | Role |
|---|---|---|
| Peter J Winkle, MD | Anaheim Clinical Trials | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials, LLC | Anaheim | California | 92801 | United States |
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| Placebo | Drug | VIS954 Placebo |
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