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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06523153




Registration number
NCT06523153
Ethics application status
Date submitted
18/07/2024
Date registered
26/07/2024

Titles & IDs
Public title
A Study of the Investigational Monoclonal Antibody, VYD2311, in Healthy Participants
Scientific title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of a SARS-CoV-2-directed Monoclonal Antibody in Healthy Participants
Secondary ID [1] 0 0
VYD2311-1-001
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: Other - VYD2311
Other interventions - Placebo

Experimental: VYD2311 - Injection in healthy volunteer

Placebo comparator: Placebo - Injection in healthy volunteer


Treatment: Other: VYD2311
Monoclonal antibody

Other interventions: Placebo
Matching Placebo
Intervention code [1] 0 0
Treatment: Other
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 Month-6 visit
Secondary outcome [1] 0 0
PK parameter of VYD2311, AUC0-inf (area under the concentration-time curve from time 0 extrapolated to infinity)
Timepoint [1] 0 0
Through Month-6 visit
Secondary outcome [2] 0 0
PK parameter of VYD2311, AUClast (area under the concentration-time curve from time 0 to the last quantifiable concentration)
Timepoint [2] 0 0
Through Month-6 visit
Secondary outcome [3] 0 0
PK parameter of VYD2311, AUC0-t (area under the concentration-time curve from time 0 to t)
Timepoint [3] 0 0
Through Month-6 visit
Secondary outcome [4] 0 0
PK parameter of VYD2311, Cmax (maximum serum concentration)
Timepoint [4] 0 0
Through Month-6 visit
Secondary outcome [5] 0 0
PK parameter of VYD2311, Tmax (time to reach maximum serum concentration)
Timepoint [5] 0 0
Through Month-6 visit
Secondary outcome [6] 0 0
PK parameter of VYD2311, CL (clearance)
Timepoint [6] 0 0
Through Month-6 visit
Secondary outcome [7] 0 0
PK parameter of VYD2311, t1/2 (half-life)
Timepoint [7] 0 0
Through Month-6 visit
Secondary outcome [8] 0 0
PK parameter of VYD2311, Vss (apparent volume of distribution at steady state)
Timepoint [8] 0 0
Through Month-6 visit
Secondary outcome [9] 0 0
PK parameter of VYD2311, Vz (apparent volume of distribution during terminal phase)
Timepoint [9] 0 0
Through Month-6 visit
Secondary outcome [10] 0 0
Incidence of ADAs against VYD2311
Timepoint [10] 0 0
Through Month-6 visit

Eligibility
Key inclusion criteria
* Is a male or female participant aged 18 to 65 years, inclusive.
* Has a body mass index 18.0 to 32.0 kg/m2, inclusive.
* Is in good health, with no clinically significant abnormalities as determined by the Investigator based on medical history, physical exam, vital signs, ECG, and laboratory values per study unit standard operating procedures.
* Tests negative for current SARS-CoV-2 infection by rapid antigen test on screening and Day -1.
* For participants assigned female sex at birth:

* Is not of childbearing potential (defined in protocol), OR
* Is of childbearing potential (defined in protocol) and practicing highly effective contraception (defined in protocol) for at least 28 days before dosing (Day 1) through 6 months after dosing and has negative results on pregnancy tests at Screening and on Day -1.
* Is able and willing to provide written informed consent.
* Is able to understand the study procedures and willing to adhere to all protocol requirements.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Has a known or suspected allergy, intolerance, or hypersensitivity to any component of the study drug, including excipients and closely related compounds (eg, other mAbs).
* Intends to receive a COVID-19 vaccine/booster within 3 months of Day 1.
* Is pregnant, breastfeeding, or seeking pregnancy while on study.
* Has any chronic or significant medical condition that, in the assessment of the Investigator, might compromise participant safety or interfere with evaluation of the study drug or interpretation of participant safety/study results, including but not limited to significant neurologic, renal, hepatic, hematologic, immune, cardiac, pulmonary, metabolic, endocrine, psychiatric, vascular, or gastrointestinal disorders.
* 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 (eg, 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, as indicated by any of the following: positive antibody, antigen, or nucleic acid amplification test result for HIV; positive HBV surface antigen; positive HCV antibody with positive HCV RNA (positive antibody test with negative RNA test is not exclusionary).
* Has current alcoholism or recreational drug use, including a positive test result for marijuana, amphetamines, barbiturates, cocaine, opiates, phencyclidine and benzodiazepines, or alcohol.
* Is a current or former regular cigarette smoker (more than 5 cigarettes per day within the last year). Individuals who currently or previously smoked 5 or fewer cigarettes per day are allowed if they agree to abstain from smoking during confinement at the CRU.
* 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 has 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 or previously received pemivibart (VYD222) at any time.
* Has taken prescription or OTC medications or supplements within 5 half-lives of the specific substance (or, if half-life is not known, within 48 hours) before the scheduled administration of study drug, with the following exceptions:

* Influenza or COVID-19 vaccination more than 14 days prior to dosing, or any other vaccine more than 4 weeks prior to dosing
* Hormonal contraceptives
* Standard of care use of acetaminophen/paracetamol
* Vitamins and other nutritional supplements that are not newly introduced (ie, have been taken for at least 30 days prior to enrollment)
* Other OTC medications that, in the judgement of the Investigator or medically qualified designee, will not impact the safety of the participant or data integrity of the study.
* Screening or predose systolic blood pressure that repeatedly measures below approximately 100 mm Hg. If systolic blood pressure measures below 100 mm Hg, the measurement may be repeated twice. If the average of all three measurements is greater than or equal to 100 mm Hg, the participant may be considered eligible as determined by the Investigator or medically qualified designee.
* In the opinion of the Investigator, is unable to comply with the study protocol.

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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/08/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2025
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Invivyd Investigative Site - Joondalup
Recruitment postcode(s) [1] 0 0
- 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
Study Inquiry
Address 0 0
Country 0 0
Phone 0 0
+1 781-819-0080
Fax 0 0
Email 0 0
ClinicalTrials@invivyd.com
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/NCT06523153