A study to investigate the safety, tolerability, and pharmacokinetics of aSARS-CoV-2-directed monoclonal antibody in healthy participants
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, IM, or SC 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, IM, or SC administration in healthy participants.
Biological: VYD2311
Monoclonal antibody
Other: Placebo
Matching Placebo
Other Name: 0.9% sodium chloride
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.
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.
Invivyd Investigative Site
Joondalup, Western Australia, Australia
Not Provided