The main purposes of this research study are to measure the safety (whether it causes any side effects), tolerability (if it does cause any side effects, how well your body is able to handle them), and reactions, both local at the injection site and systemic, that may occur in the body after receiving VYD2311, or a COVID-19 vaccine, or a combination of VYD2311 and a COVID-19 vaccine in healthy participants. This research study will measure the amount of serum virus neutralizing antibodies produced in the blood (antibodies that block a virus from infecting cells) and pharmacokinetics of VYD2311 compared to a COVID-19 vaccine, when each is administered alone or concurrently. Pharmacokinetics is the study of how a drug moves through the body, including how it is absorbed (taken into the body), distributed (spread throughout the body), metabolized (broken down in the body), and eliminated (removed from the body), and how the body affects the drug.
Is a healthy adult male or female aged 18 to 49 years, inclusive, weighing at least 40 kg at the time of Screening
Has a body mass index (BMI) 18.0 to 32.0 mg/kg2, inclusive.
Is in good health, with no clinically significant abnormalities as determined by the Investigator based on medical history, physical exam, vital signs, and ECG per study site standard operating procedures.
Prior receipt of VYD2311 or pemivibart (VYD222).
Prior receipt of a COVID-19 vaccine within 6 months before Day 0 and prior receipt of a non-COVID-19 vaccine within 28 days before Day 0.
Prior receipt of convalescent plasma, a mAb to SARS-CoV-2 (other than VYD2311 or pemivibart), or IVIG within 6 months before Day 0.
Prior known or suspected SARS-CoV-2 infection within 6 months before Day 0.
Parallel
COVID-19 mRNA vaccine
DrugA one-time dose of COVID-19 mRNA vaccine will be administered by intramuscular injection.
VYD2311
DrugA one-time dose of VYD2311 250mg will be administered by intramuscular injection.
Placebo (Normal Saline)
DrugA one-time dose of normal saline (placebo) administered by intramuscular injection.
Assessment of safety based on treatment emergent adverse events, injection site reactions, and hypersensitivity reactions through day 6
Assessment of systemic reactions solicited via e-diary through day 6
To compare the systemic reaction of VYD2311 (study drug) with a COVID-19 vaccine when administered alone or concurrently in healthy adults. E-diaries will solicit participant reported systemic reactions including vomiting, fever, diarrhea, headache, fatigue, chills, myalgia, and arthralgia.
Assessment of safety based on treatment emergent adverse events, injection site reactions, and hypersensitivity reactions through day 56
sVNA titers (VYD2311 serum concentration/variant IC50) against relevant SARS-CoV-2 variants through Day 56
Serum concentrations of VYD2311 through Day 56
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