MedPath

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

Phase 1
Completed
Conditions
COVID-19
Interventions
Drug: VYD222
Other: 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
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
Read More
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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Arm && Interventions
GroupInterventionDescription
Cohort 1VYD22210 total participants Cohort 1. 8 participants on VYD222 2 participants on placebo
Cohort 1Placebo10 total participants Cohort 1. 8 participants on VYD222 2 participants on placebo
Cohort 2VYD22210 total participants Cohort 2. 8 participants on VYD222 2 participants on placebo
Cohort 2Placebo10 total participants Cohort 2. 8 participants on VYD222 2 participants on placebo
Cohort 3VYD22210 total participants Cohort 3. 8 participants on VYD222 2 participants on placebo
Cohort 3Placebo10 total participants Cohort 3. 8 participants on VYD222 2 participants on placebo
Primary Outcome Measures
NameTimeMethod
Incidence of TEAEs (including AEs and SAEs)Through 12 Months
Secondary Outcome Measures
NameTimeMethod
Incidence of ADAs against VYD22212 Months
Assessment of PK Parameter: area under the concentration-time curve from time zero extrapolated to infinity for VYD22212 Months
Assessment of PK Parameter: area under the concentration-time curve from time zero to the last measurable concentration for VYD22212 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 VYD22212 Months
Assessment of PK Parameter: area under the concentration-time curve from time zero to t for VYD22212 Months
Assessment of PK Parameter: Clearance of VYD22212 Months
Assessment of PK Parameter: Half-life of VYD22212 Months
Assessment of PK Parameter: volume of distribution at steady state of VYD22212 Months

Trial Locations

Locations (1)

Linear Clinical Research

🇦🇺

Joondalup, Western Australia, Australia

© Copyright 2025. All Rights Reserved by MedPath