At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-1654 in Pre-Term and Full-Term Infants
In Brief
A Phase 2 clinical trial evaluating Clesrovimab and Placebo for Respiratory Tract Infection and Respiratory Syncytial Virus. Completed, enrolled 183 participants across 34 sites in 6 countries.
Detailed Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and incidence of anti-drug antibodies (ADAs) of single ascending doses of clesrovimab in healthy pre-term (born at 29 to 35 weeks gestational age) and full-term (born at \>35 weeks gestational age) infants. Participants will be randomized into 1 of 4 dose escalation panels (Panels A to D); an additional panel (Panel E) of full-term infants will receive the same dose as Panel D. Key safety and tolerability variables will be reviewed after each dose panel prior to administering the next-highest dose.
Study Details
Timeline
Interventions
Single ascending doses of clesrovimab will be administered via IM injection.
Placebo (0.9% sodium chloride \[NaCl\]) will be administered via IM injection.