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

Invivyd, Inc.1 site in 1 country40 target enrollmentAugust 28, 2024

ConditionsCOVID-19

InterventionsVYD2311 Placebo

DrugsVYD2311

Overview

Phase: Phase 1
Intervention: VYD2311
Conditions: COVID-19
Sponsor: Invivyd, Inc.
Enrollment: 40
Locations: 1
Primary Endpoint: Incidence of TEAEs (including AEs and SAEs)
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials Related News

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

August 28, 2024

End Date

May 2025

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Invivyd, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Is a male or female participant aged 18 to 65 years, inclusive.
•Has a body mass index 18.0 to 32.0 kg/m2, inclusive.
•Is in good health, with no clinically significant abnormalities as determined by the Investigator based on medical history, physical exam, vital signs, ECG, and laboratory values per study unit standard operating procedures.
•Tests negative for current SARS-CoV-2 infection by rapid antigen test on screening and Day -
•For participants assigned female sex at birth:
•Is not of childbearing potential (defined in protocol), OR
•Is of childbearing potential (defined in protocol) and practicing highly effective contraception (defined in protocol) for at least 28 days before dosing (Day 1) through 6 months after dosing and has negative results on pregnancy tests at Screening and on Day -
•Is able and willing to provide written informed consent.
•Is able to understand the study procedures and willing to adhere to all protocol requirements.

Exclusion Criteria

•Has a known or suspected allergy, intolerance, or hypersensitivity to any component of the study drug, including excipients and closely related compounds (eg, other mAbs).
•Intends to receive a COVID-19 vaccine/booster within 3 months of Day
•Is pregnant, breastfeeding, or seeking pregnancy while on study.
•Has any chronic or significant medical condition that, in the assessment of the Investigator, might compromise participant safety or interfere with evaluation of the study drug or interpretation of participant safety/study results, including but not limited to significant neurologic, renal, hepatic, hematologic, immune, cardiac, pulmonary, metabolic, endocrine, psychiatric, vascular, or gastrointestinal disorders.
•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 (eg, 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, as indicated by any of the following: positive antibody, antigen, or nucleic acid amplification test result for HIV; positive HBV surface antigen; positive HCV antibody with positive HCV RNA (positive antibody test with negative RNA test is not exclusionary).
•Has current alcoholism or recreational drug use, including a positive test result for marijuana, amphetamines, barbiturates, cocaine, opiates, phencyclidine and benzodiazepines, or alcohol.
•Is a current or former regular cigarette smoker (more than 5 cigarettes per day within the last year). Individuals who currently or previously smoked 5 or fewer cigarettes per day are allowed if they agree to abstain from smoking during confinement at the CRU.
•Has donated more than 500 mL of blood within 60 days before the scheduled dose of study drug.

Arms & Interventions

VYD2311

Injection in healthy volunteer

Intervention: VYD2311

Placebo

Injection in healthy volunteer

Intervention: Placebo

Outcomes

Primary Outcomes

Incidence of TEAEs (including AEs and SAEs)

Time Frame: Through Month-6 visit

Secondary Outcomes

PK parameter of VYD2311, Tmax (time to reach maximum serum concentration)(Through Month-6 visit)
PK parameter of VYD2311, AUC0-t (area under the concentration-time curve from time 0 to t)(Through Month-6 visit)
PK parameter of VYD2311, CL (clearance)(Through Month-6 visit)
PK parameter of VYD2311, Vz (apparent volume of distribution during terminal phase)(Through Month-6 visit)
Incidence of ADAs against VYD2311(Through Month-6 visit)
PK parameter of VYD2311, AUClast (area under the concentration-time curve from time 0 to the last quantifiable concentration)(Through Month-6 visit)
PK parameter of VYD2311, t1/2 (half-life)(Through Month-6 visit)
PK parameter of VYD2311, Vss (apparent volume of distribution at steady state)(Through Month-6 visit)
PK parameter of VYD2311, AUC0-inf (area under the concentration-time curve from time 0 extrapolated to infinity)(Through Month-6 visit)
PK parameter of VYD2311, Cmax (maximum serum concentration)(Through Month-6 visit)