NCT03524118

Safety, Tolerability, and Pharmacokinetics of Clesrovimab (MK-1654) in Infants (MK-1654-002)

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 183 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 2 Weeks – 8 Months
• Healthy volunteers: Accepted

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.

Detailed description

Participants in Dose Panels A, B, C, D1, and E1 will be followed for up to 365 days. After protocol Amendment 4 (AM4), participants in Dose Panels D2 and E2 will be followed for up to 545 days.

Conditions

• Respiratory Tract Infection
• Respiratory Syncytial Virus

Interventions

Type	Name	Description
DRUG	Clesrovimab	Single ascending doses of clesrovimab will be administered via IM injection.
DRUG	Placebo	Placebo (0.9% sodium chloride \[NaCl\]) will be administered via IM injection.

Timeline

• Start date: 2018-09-20
• Primary completion: 2022-09-14
• Completion: 2022-09-14
• First posted: 2018-05-14
• Last updated: 2025-01-14
• Results posted: 2023-11-29

Locations

34 sites across 6 countries: United States, Chile, Colombia, South Africa, South Korea, Spain

Regulatory

• FDA-regulated drug study