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

NCT06523153 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: VYD2311-1-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Incidence of TEAEs (including AEs and SAEs)

  Through Month-6 visit

Secondary Outcomes (10)

• 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, AUClast (area under the concentration-time curve from time 0 to the last quantifiable 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, Cmax (maximum serum concentration)

  Through Month-6 visit

• PK parameter of VYD2311, Tmax (time to reach maximum serum concentration)

  Through Month-6 visit

Study Arms (2)

VYD2311

EXPERIMENTAL

Injection in healthy volunteer

Biological: VYD2311

Placebo

PLACEBO COMPARATOR

Injection in healthy volunteer

Other: Placebo

Interventions

VYD2311 BIOLOGICAL

Monoclonal antibody

VYD2311

Placebo OTHER

Matching Placebo

Also known as: 0.9% sodium chloride

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -1.
• 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 -1.
• Is able and willing to provide written informed consent.
• Is able to understand the study procedures and willing to adhere to all protocol requirements.

You may not qualify if:

• 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 1.
• 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 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.
• Had major surgery within 30 days prior to study drug dosing or has 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 or previously received pemivibart (VYD222) at any time.
• Has taken prescription or OTC medications or supplements within 5 half-lives of the specific substance (or, if half-life is not known, within 48 hours) before the scheduled administration of study drug, with the following exceptions:
• Influenza or COVID-19 vaccination more than 14 days prior to dosing, or any other vaccine more than 4 weeks prior to dosing

Sponsors & Collaborators

• Invivyd, Inc.: lead
• Novotech (Australia) Pty Limited: collaborator

Study Sites (1)

Invivyd Investigative Site

Joondalup, WA 6027, Australia

Location

MeSH Terms

Conditions

COVID-19

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double blind, placebo controlled

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 26, 2024
• Study Start: August 28, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)