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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-28

Study Completion Date

2024-05-08

Brief Summary

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

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Detailed Description

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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.

Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Randomized, triple blind, placebo controlled

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cohort 1

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

Group Type EXPERIMENTAL

VYD222

Intervention Type DRUG

Monoclonal antibody

Placebo

Intervention Type OTHER

Matching Placebo

Cohort 2

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

Group Type EXPERIMENTAL

VYD222

Intervention Type DRUG

Monoclonal antibody

Placebo

Intervention Type OTHER

Matching Placebo

Cohort 3

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

Group Type EXPERIMENTAL

VYD222

Intervention Type DRUG

Monoclonal antibody

Placebo

Intervention Type OTHER

Matching Placebo

Interventions

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VYD222

Monoclonal antibody

Intervention Type DRUG

Placebo

Matching Placebo

Intervention Type OTHER

Other Intervention Names

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0.9% sodium chloride

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes