Clinical trial NCT05791318: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: COVID-19
Lead sponsor: Invivyd, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Novotech (Australia) Pty Limited
First posted: 2023-03-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Randomized, triple blind, placebo controlled
Primary purpose: OTHER

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of TEAEs (including AEs and SAEs)
timeFrame: Through 12 Months
Secondary outcomes:
measure: Incidence of ADAs against VYD222
timeFrame: 12 Months
measure: Assessment of PK Parameter: area under the concentration-time curve from time zero extrapolated to infinity for VYD222
timeFrame: 12 Months
measure: Assessment of PK Parameter: area under the concentration-time curve from time zero to the last measurable concentration for VYD222
timeFrame: 12 Months
measure: Assessment of PK Parameter: area under the concentration-time curve from time zero to t for VYD222
timeFrame: 12 Months
measure: Assessment of PK Parameter: Cmax (maximum serum concentration)
timeFrame: 12 Months
measure: Assessment of PK Parameter: Tmax (time to reach maximum serum concentration)
timeFrame: 12 Months
measure: Assessment of PK Parameter: Clearance of VYD222
timeFrame: 12 Months
measure: Assessment of PK Parameter: Half-life of VYD222
timeFrame: 12 Months
measure: Assessment of PK Parameter: volume of distribution at steady state of VYD222
timeFrame: 12 Months
measure: Assessment of PK Parameter: volume of distribution during terminal phase of VYD222
timeFrame: 12 Months
Other outcomes:
Locations:
city: Joondalup
country: Australia
facility: Linear Clinical Research
state: Western Australia
Study officials:
References: