CompletedNCT05791318Updated May 31, 2024

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

A Phase 1 interventional study of VYD222 and Placebo in COVID-19, sponsored by Invivyd, Inc.. Completed at 1 site in Australia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-31.

Sponsored by Invivyd, Inc. · Phase 1, Interventional, and Other

From the registry’s dates

Primary completion was May 2024, 2 years 5 months ago, and no results have been posted to the registry.

Phase: Phase 1
Study type: Interventional
Enrollment: 30
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

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

Read the 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.

Conditions studied

COVID-19

In context

Lead sponsor

Invivyd, Inc. is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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 design

Phase: Phase 1
Primary purpose: Other
Allocation: Randomized
Intervention model: Sequential assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 30 participants (actual)

Study arms

Experimental
Cohort 1
10 total participants Cohort 1. 8 participants on VYD222 2 participants on placebo
Drug: VYD222 · Other: Placebo
Experimental
Cohort 2
10 total participants Cohort 2. 8 participants on VYD222 2 participants on placebo
Drug: VYD222 · Other: Placebo
Experimental
Cohort 3
10 total participants Cohort 3. 8 participants on VYD222 2 participants on placebo
Drug: VYD222 · Other: Placebo

Interventions

DrugVYD222
Monoclonal antibody
OtherPlacebo
Matching Placebo
Also known as: 0.9% sodium chloride

What researchers measure

Primary outcomes

Incidence of TEAEs (including AEs and SAEs)
Time frame: Through 12 Months

Secondary outcomes

Incidence of ADAs against VYD222
Time frame: 12 Months
Assessment of PK Parameter: area under the concentration-time curve from time zero extrapolated to infinity for VYD222
Time frame: 12 Months
Assessment of PK Parameter: area under the concentration-time curve from time zero to the last measurable concentration for VYD222
Time frame: 12 Months
Assessment of PK Parameter: area under the concentration-time curve from time zero to t for VYD222
Time frame: 12 Months
Assessment of PK Parameter: Cmax (maximum serum concentration)
Time frame: 12 Months
Assessment of PK Parameter: Tmax (time to reach maximum serum concentration)
Time frame: 12 Months
Assessment of PK Parameter: Clearance of VYD222
Time frame: 12 Months
Assessment of PK Parameter: Half-life of VYD222
Time frame: 12 Months
Assessment of PK Parameter: volume of distribution at steady state of VYD222
Time frame: 12 Months
Assessment of PK Parameter: volume of distribution during terminal phase of VYD222
Time frame: 12 Months

Study locations

1 site

Linear Clinical Research
Joondalup, Western Australia 6027, Australia

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05791318
Lead sponsor: Invivyd, Inc.
Collaborators: Novotech (Australia) Pty Limited
Responsible party: Sponsor
First posted: Mar 30, 2023
Start date: Mar 28, 2023
Primary completion: May 8, 2024
Completion: May 8, 2024
Last update: May 31, 2024

Oversight

FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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