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

Trial ID or NCT#

NCT05791318

Status

not recruiting iconNOT RECRUITING

Purpose

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

Official Title

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

Eligibility Criteria

Ages Eligible for Study: 18 to 65
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
  1. * 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
    1. Exclusion Criteria:
  2. * 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
Exclusion Criteria:
  1. apply
    1. Exclusion Criteria:
      1. * 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
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Investigator(s)

Peter Schmidt
Peter Schmidt
Anesthesiologist, Pain management specialist
Clinical Assistant Professor, Anesthesiology, Perioperative and Pain Medicine

View on ClinicalTrials.gov