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

Invivyd

Status and phase: Completed; Phase 1

Conditions: COVID-19

Treatments: Drug: VYD222; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05791318

VYD222-1-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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30 participants in 3 patient groups

Cohort 1

Experimental group

Description:

10 total participants Cohort 1. 8 participants on VYD222 2 participants on placebo

Treatment:

Other: Placebo

Drug: VYD222

Cohort 2

Experimental group

Description:

10 total participants Cohort 2. 8 participants on VYD222 2 participants on placebo

Treatment:

Other: Placebo

Drug: VYD222

Cohort 3

Experimental group

Description:

10 total participants Cohort 3. 8 participants on VYD222 2 participants on placebo

Treatment:

Other: Placebo

Drug: VYD222