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

A Phase 1, Randomized, Triple-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of the Monoclonal Antibody VYD222 in Healthy Adult Participants

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

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19
• Intervention / Treatment: Other: Placebo; Drug: VYD222

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Study Inquiry; Phone Number: +1 781-819-0080; Email: ClinicalTrials@invivyd.com

Study Locations

• Australia
  • Western Australia
    • Joondalup, Western Australia, Australia, 6027
      • Linear Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; 10 total participants Cohort 1. 8 participants on VYD222 2 participants on placebo	Other: Placebo; Matching Placebo; Other Names: 0.9% sodium chloride; Drug: VYD222; Monoclonal antibody
Experimental: Cohort 2; 10 total participants Cohort 2. 8 participants on VYD222 2 participants on placebo	Other: Placebo; Matching Placebo; Other Names: 0.9% sodium chloride; Drug: VYD222; Monoclonal antibody
Experimental: Cohort 3; 10 total participants Cohort 3. 8 participants on VYD222 2 participants on placebo	Other: Placebo; Matching Placebo; Other Names: 0.9% sodium chloride; Drug: VYD222; Monoclonal antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of TEAEs (including AEs and SAEs)	Through 12 Months

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of ADAs against VYD222	12 Months
Assessment of PK Parameter: area under the concentration-time curve from time zero extrapolated to infinity for VYD222	12 Months
Assessment of PK Parameter: area under the concentration-time curve from time zero to the last measurable concentration for VYD222	12 Months
Assessment of PK Parameter: area under the concentration-time curve from time zero to t for VYD222	12 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: Clearance of VYD222	12 Months
Assessment of PK Parameter: Half-life of VYD222	12 Months
Assessment of PK Parameter: volume of distribution at steady state of VYD222	12 Months
Assessment of PK Parameter: volume of distribution during terminal phase of VYD222	12 Months

Collaborators and Investigators

• Sponsor: Invivyd, Inc.
• Collaborators: Novotech (Australia) Pty Limited

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: March 16, 2023
• First Submitted That Met QC Criteria: March 28, 2023
• First Posted (Actual): March 30, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 20, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: VYD222-1-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No