NCT05791318

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 covid19

Timeline
Completed

Started Mar 2023

Typical duration for phase_1 covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

March 28, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 30, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2024

Completed
Last Updated

May 31, 2024

Status Verified

May 1, 2024

Enrollment Period

1.1 years

First QC Date

March 16, 2023

Last Update Submit

May 30, 2024

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

  • Incidence of TEAEs (including AEs and SAEs)

    Through 12 Months

Secondary Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (3)

Cohort 1

EXPERIMENTAL

10 total participants Cohort 1. 8 participants on VYD222 2 participants on placebo

Drug: VYD222Other: Placebo

Cohort 2

EXPERIMENTAL

10 total participants Cohort 2. 8 participants on VYD222 2 participants on placebo

Drug: VYD222Other: Placebo

Cohort 3

EXPERIMENTAL

10 total participants Cohort 3. 8 participants on VYD222 2 participants on placebo

Drug: VYD222Other: Placebo

Interventions

VYD222DRUG

Monoclonal antibody

Cohort 1Cohort 2Cohort 3
PlaceboOTHER

Matching Placebo

Also known as: 0.9% sodium chloride
Cohort 1Cohort 2Cohort 3

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linear Clinical Research

Joondalup, Western Australia, 6027, Australia

Location

MeSH Terms

Conditions

COVID-19

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium 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
Model Details: Randomized, triple blind, placebo controlled
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2023

First Posted

March 30, 2023

Study Start

March 28, 2023

Primary Completion

May 8, 2024

Study Completion

May 8, 2024

Last Updated

May 31, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)