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

Conditions

COVID-19

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.

Kathryn Mahoney, Deepali Gupta, Yong Li, Natalia Betancourt, Aanika Das et al. (7 authors)

Open Forum Infectious Diseases2023-11-272 citations

10.1093/ofid/ofad500.1200

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Michael G. Ison, Debra F. Weinstein, Marta Dobryanska, Anna Holmes, Anne-Marie Phelan et al. (16 authors)

Open Forum Infectious Diseases2023-06-1320 citations

10.1093/ofid/ofad314

Efficacy and Safety of Adintrevimab (ADG20) for the Treatment of High-Risk Ambulatory Patients With Mild or Moderate COVID-19: Results From a Phase 2/3, Randomized, Placebo-Controlled Trial (STAMP) Conducted During Delta Predominance and Early Emergence of Omicron

Michael G. Ison, Myra W. Popejoy, Nikolay Evgeniev, M. Tzekova, Kathryn Mahoney et al. (61 authors)

Open Forum Infectious Diseases2023-05-2412 citations

10.1093/ofid/ofad279

Interventions

DRUGVYD222

Monoclonal antibody

OTHERPlacebo

Matching Placebo

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

OTHER

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Randomized, triple blind, placebo controlled

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

Australia

Outcome results

None listed