A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of the Monoclonal Antibody VYD222 in Healthy Adult Participants

Study Overview
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Brief Summary
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A study to investigate the safety, tolerability, and pharmacokinetics of the monoclonal antibody VYD222 in healthy adult participants.

Detailed Description
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This is a Phase I, first-in-human, randomized, triple blind, single escalating dose study to evaluate the safety and tolerability of VYD222, a monoclonal antibody targeting SARS-CoV-2, in healthy adult volunteers. The primary objective is to evaluate the safety and tolerability of multiple dose levels of VYD222 after a single administration in healthy participants. The secondary objective is to evaluate the plasma pharmacokinetics and immunogenicity of VYD222 after administration in healthy participants.

Official Title
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A Phase 1, Randomized, Triple-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of the Monoclonal Antibody VYD222 in Healthy Adult Participants

Conditions
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COVID-19

Intervention / Treatment
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* Drug: VYD222
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has a body mass index 18.5 to 32.0 kg/m2, inclusive. Negative for current SARS-CoV-2 infection by rapid antigen test on Day -1. Is seropositive to N and/or S SARS-CoV-2 antigens at Screening. For participants assigned female sex at birth: Is not of childbearing potential OR is of childbearing potential and practicing highly effective contraception. Is able and willing to provide written informed consent. NOTE: Other protocol defined inclusion/exclusion criteria apply Exclusion Criteria: Intends to receive a COVID-19 vaccine/booster within 3 months of Day 1. Is pregnant, breastfeeding, or seeking pregnancy while on study. Has a history of a malignancy (or active malignancy), except for participants with basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the cervix who have been treated and cured. Has had any symptoms of acute respiratory illness (e.g., cough, shortness of breath, sore throat, fatigue, loss of smell, fever), or other febrile illness within 2 weeks prior to dosing. Has evidence of active infection with HIV, HBV, or HCV. Has donated more than 500 mL of blood within 60 days before the scheduled dose of study drug. Had major surgery within 30 days prior to study drug dosing or planned surgeries within 12 months after planned study drug dosing. Received any investigational drug or biologic within 30 days or 5 half-lives (whichever is longer) prior to Screening or planned administration of any investigational drug or biologic during the study period. Received immunoglobulin or blood products within 6 months prior to Screening. Previously received a mAb within 6 months or 5 half-lives (whichever is longer) prior to Screening. NOTE: Other protocol defined inclusion/exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Randomized, triple blind, placebo controlled
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>10 total participants Cohort 1. 8 participants on VYD222 2 participants on placebo | Drug: VYD222<br>* Monoclonal antibody<br>Other: Placebo<br>* Matching Placebo<br>* Other names: 0.9% sodium chloride;|
| Experimental: Cohort 2<br>10 total participants Cohort 2. 8 participants on VYD222 2 participants on placebo | Drug: VYD222<br>* Monoclonal antibody<br>Other: Placebo<br>* Matching Placebo<br>* Other names: 0.9% sodium chloride;|
| Experimental: Cohort 3<br>10 total participants Cohort 3. 8 participants on VYD222 2 participants on placebo | Drug: VYD222<br>* Monoclonal antibody<br>Other: Placebo<br>* Matching Placebo<br>* Other names: 0.9% sodium chloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of TEAEs (including AEs and SAEs) |  | Through 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of ADAs against VYD222 |  | 12 Months | 
| Assessment of PK Parameter: area under the concentration-time curve from time zero extrapolated to infinity for VYD222 |  | 12 Months | 
| Assessment of PK Parameter: area under the concentration-time curve from time zero to the last measurable concentration for VYD222 |  | 12 Months | 
| Assessment of PK Parameter: area under the concentration-time curve from time zero to t for VYD222 |  | 12 Months | 
| Assessment of PK Parameter: Cmax (maximum serum concentration) |  | 12 Months | 
| Assessment of PK Parameter: Tmax (time to reach maximum serum concentration) |  | 12 Months | 
| Assessment of PK Parameter: Clearance of VYD222 |  | 12 Months | 
| Assessment of PK Parameter: Half-life of VYD222 |  | 12 Months | 
| Assessment of PK Parameter: volume of distribution at steady state of VYD222 |  | 12 Months | 
| Assessment of PK Parameter: volume of distribution during terminal phase of VYD222 |  | 12 Months |