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A Study of the Investigational Monoclonal Antibody, VYD2311, in Healthy Participants

PHASE1RECRUITING

A study to investigate the safety, tolerability, and pharmacokinetics of a SARS-CoV-2-directed monoclonal antibody in healthy participants.

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Study details:

This is a Phase I, first-in-human, randomized, double blind, placebo controlled, single escalating dose study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of VYD2311, a monoclonal antibody targeting SARS-CoV-2, in healthy volunteers. The primary objective is to evaluate the safety and tolerability of multiple dose levels of VYD2311 after a single IV or IM administration in healthy participants. The secondary objectives are to evaluate the PK of VYD2311 after IV or IM administration and the immunogenicity of VYD2311 after IV or IM administration in healthy participants.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

Is able and willing to provide written informed consent.

Is able to understand the study procedures and willing to adhere to all protocol requirements.

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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : Yes

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-08-28

Primary completion: 2025-04-01

Study completion finish: 2025-04-01

Study type

OTHER

Phase

PHASE1

Trial ID

NCT06523153

Intervention or treatment

BIOLOGICAL: VYD2311

OTHER: Placebo

Conditions

• COVID-19

Condition: COVID-19
BIOLOGICAL: VYD2311 and other drugs
Joondalup, Western Australia, Australia
Sponsor: Invivyd, Inc.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Invivyd Investigative Site

Research sites nearby

Select from list below to view details:

Invivyd Investigative Site
Joondalup, Western Australia, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: VYD2311 Injection in healthy volunteer	BIOLOGICAL: VYD2311 Monoclonal antibody
PLACEBO_COMPARATOR: Placebo Injection in healthy volunteer	OTHER: Placebo Matching Placebo

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Incidence of TEAEs (including AEs and SAEs)	Not Specified	Through Month-6 visit

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
PK parameter of VYD2311, AUC0-inf (area under the concentration-time curve from time 0 extrapolated to infinity)	Not Specified	Through Month-6 visit
PK parameter of VYD2311, AUClast (area under the concentration-time curve from time 0 to the last quantifiable concentration)	Not Specified	Through Month-6 visit
PK parameter of VYD2311, AUC0-t (area under the concentration-time curve from time 0 to t)	Not Specified	Through Month-6 visit
PK parameter of VYD2311, Cmax (maximum serum concentration)	Not Specified	Through Month-6 visit
PK parameter of VYD2311, Tmax (time to reach maximum serum concentration)	Not Specified	Through Month-6 visit
PK parameter of VYD2311, CL (clearance)	Not Specified	Through Month-6 visit
PK parameter of VYD2311, t1/2 (half-life)	Not Specified	Through Month-6 visit
PK parameter of VYD2311, Vss (apparent volume of distribution at steady state)	Not Specified	Through Month-6 visit
PK parameter of VYD2311, Vz (apparent volume of distribution during terminal phase)	Not Specified	Through Month-6 visit
Incidence of ADAs against VYD2311	Not Specified	Through Month-6 visit

Frequently Asked Questions

Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol

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You may be eligible to participate in this trial based on your search.Apply for study

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References

Clinical Trials Gov: A Study of the Investigational Monoclonal Antibody, VYD2311, in Healthy Participants