NCT06523153

A Study of the Investigational Monoclonal Antibody, VYD2311, in Healthy Participants

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of a SARS-CoV-2-directed Monoclonal Antibody in Healthy Participants

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Invivyd, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

A study to investigate the safety, tolerability, and pharmacokinetics of a SARS-CoV-2-directed monoclonal antibody in healthy participants

Detailed description

This is a Phase I, first-in-human, randomized, double blind, placebo controlled, single escalating dose study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of VYD2311, a monoclonal antibody targeting SARS-CoV-2, in healthy volunteers. The primary objective is to evaluate the safety and tolerability of multiple dose levels of VYD2311 after a single IV, IM, or SC administration in healthy participants. The secondary objectives are to evaluate the PK of VYD2311 after IV or IM administration and the immunogenicity of VYD2311 after IV, IM, or SC administration in healthy participants.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	VYD2311	Monoclonal antibody
OTHER	Placebo	Matching Placebo

Timeline

• Start date: 2024-08-28
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2024-07-26
• Last updated: 2024-11-19

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study