Share
Save
A Study of the Investigational Monoclonal Antibody, VYD2311, in Healthy Participants
A study to investigate the safety, tolerability, and pharmacokinetics of a SARS-CoV-2-directed monoclonal antibody in healthy participants.
Study details:
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 or IM 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 or IM administration in healthy participants.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : Yes
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-08-28
Primary completion: 2025-04-01
Study completion finish: 2025-04-01
Study type
OTHER
Phase
PHASE1
Trial ID
NCT06523153
Intervention or treatment
BIOLOGICAL: VYD2311
OTHER: Placebo
Conditions
- • COVID-19
Find a site
Closest Location:
Invivyd Investigative Site
Research sites nearby
Select from list below to view details:
Invivyd Investigative Site
Joondalup, Western Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: VYD2311
| BIOLOGICAL: VYD2311
|
PLACEBO_COMPARATOR: Placebo
| OTHER: Placebo
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Incidence of TEAEs (including AEs and SAEs) | Not Specified | Through Month-6 visit |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
PK parameter of VYD2311, AUC0-inf (area under the concentration-time curve from time 0 extrapolated to infinity) | Not Specified | Through Month-6 visit |
PK parameter of VYD2311, AUClast (area under the concentration-time curve from time 0 to the last quantifiable concentration) | Not Specified | Through Month-6 visit |
PK parameter of VYD2311, AUC0-t (area under the concentration-time curve from time 0 to t) | Not Specified | Through Month-6 visit |
PK parameter of VYD2311, Cmax (maximum serum concentration) | Not Specified | Through Month-6 visit |
PK parameter of VYD2311, Tmax (time to reach maximum serum concentration) | Not Specified | Through Month-6 visit |
PK parameter of VYD2311, CL (clearance) | Not Specified | Through Month-6 visit |
PK parameter of VYD2311, t1/2 (half-life) | Not Specified | Through Month-6 visit |
PK parameter of VYD2311, Vss (apparent volume of distribution at steady state) | Not Specified | Through Month-6 visit |
PK parameter of VYD2311, Vz (apparent volume of distribution during terminal phase) | Not Specified | Through Month-6 visit |
Incidence of ADAs against VYD2311 | Not Specified | Through Month-6 visit |
Frequently Asked Questions
Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol
No questions submitted. Be the first to ask a question!