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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Invivyd, Inc.
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Incidence of TEAEs (including AEs and SAEs)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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 -
- •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
- •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
Arms & Interventions
Cohort 1
10 total participants Cohort 1. 8 participants on VYD222 2 participants on placebo
Intervention: VYD222 (Drug)
Cohort 1
10 total participants Cohort 1. 8 participants on VYD222 2 participants on placebo
Intervention: Placebo (Other)
Cohort 2
10 total participants Cohort 2. 8 participants on VYD222 2 participants on placebo
Intervention: VYD222 (Drug)
Cohort 2
10 total participants Cohort 2. 8 participants on VYD222 2 participants on placebo
Intervention: Placebo (Other)
Cohort 3
10 total participants Cohort 3. 8 participants on VYD222 2 participants on placebo
Intervention: VYD222 (Drug)
Cohort 3
10 total participants Cohort 3. 8 participants on VYD222 2 participants on placebo
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Incidence of TEAEs (including AEs and SAEs)
Time Frame: Through 12 Months
Secondary Outcomes
- 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)