A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of the Monoclonal Antibody VYD222 in Healthy Adult Participants
- Conditions
- COVID-19
- Interventions
- Drug: VYD222Other: Placebo
- Registration Number
- NCT05791318
- Lead Sponsor
- Invivyd, Inc.
- Brief Summary
A study to investigate the safety, tolerability, and pharmacokinetics of the monoclonal antibody VYD222 in healthy adult participants.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Cohort 1 VYD222 10 total participants Cohort 1. 8 participants on VYD222 2 participants on placebo Cohort 1 Placebo 10 total participants Cohort 1. 8 participants on VYD222 2 participants on placebo Cohort 2 VYD222 10 total participants Cohort 2. 8 participants on VYD222 2 participants on placebo Cohort 2 Placebo 10 total participants Cohort 2. 8 participants on VYD222 2 participants on placebo Cohort 3 VYD222 10 total participants Cohort 3. 8 participants on VYD222 2 participants on placebo Cohort 3 Placebo 10 total participants Cohort 3. 8 participants on VYD222 2 participants on placebo
- Primary Outcome Measures
Name Time Method Incidence of TEAEs (including AEs and SAEs) Through 12 Months
- Secondary Outcome Measures
Name Time Method 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: Cmax (maximum serum concentration) 12 Months Assessment of PK Parameter: Tmax (time to reach maximum serum concentration) 12 Months Assessment of PK Parameter: volume of distribution during terminal phase of 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: 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
Trial Locations
- Locations (1)
Linear Clinical Research
🇦🇺Joondalup, Western Australia, Australia