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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05791318




Registration number
NCT05791318
Ethics application status
Date submitted
16/03/2023
Date registered
30/03/2023

Titles & IDs
Public title
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of the Monoclonal Antibody VYD222 in Healthy Adult Participants
Scientific 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
Secondary ID [1] 0 0
VYD222-1-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - VYD222
Other interventions - Placebo

Experimental: Cohort 1 - 10 total participants Cohort 1. 8 participants on VYD222 2 participants on placebo

Experimental: Cohort 2 - 10 total participants Cohort 2. 8 participants on VYD222 2 participants on placebo

Experimental: Cohort 3 - 10 total participants Cohort 3. 8 participants on VYD222 2 participants on placebo


Treatment: Drugs: VYD222
Monoclonal antibody

Other interventions: Placebo
Matching Placebo
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of TEAEs (including AEs and SAEs)
Timepoint [1] 0 0
Through 12 Months
Secondary outcome [1] 0 0
Incidence of ADAs against VYD222
Timepoint [1] 0 0
12 Months
Secondary outcome [2] 0 0
Assessment of PK Parameter: area under the concentration-time curve from time zero extrapolated to infinity for VYD222
Timepoint [2] 0 0
12 Months
Secondary outcome [3] 0 0
Assessment of PK Parameter: area under the concentration-time curve from time zero to the last measurable concentration for VYD222
Timepoint [3] 0 0
12 Months
Secondary outcome [4] 0 0
Assessment of PK Parameter: area under the concentration-time curve from time zero to t for VYD222
Timepoint [4] 0 0
12 Months
Secondary outcome [5] 0 0
Assessment of PK Parameter: Cmax (maximum serum concentration)
Timepoint [5] 0 0
12 Months
Secondary outcome [6] 0 0
Assessment of PK Parameter: Tmax (time to reach maximum serum concentration)
Timepoint [6] 0 0
12 Months
Secondary outcome [7] 0 0
Assessment of PK Parameter: Clearance of VYD222
Timepoint [7] 0 0
12 Months
Secondary outcome [8] 0 0
Assessment of PK Parameter: Half-life of VYD222
Timepoint [8] 0 0
12 Months
Secondary outcome [9] 0 0
Assessment of PK Parameter: volume of distribution at steady state of VYD222
Timepoint [9] 0 0
12 Months
Secondary outcome [10] 0 0
Assessment of PK Parameter: volume of distribution during terminal phase of VYD222
Timepoint [10] 0 0
12 Months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/05/2024
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Linear Clinical Research - Joondalup
Recruitment postcode(s) [1] 0 0
6027 - Joondalup

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Invivyd, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Novotech (Australia) Pty Limited
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05791318