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

NCT03524118 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 183

Last updated 2025-01-14

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
2 Weeks
Max Age
8 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-20
Primary Completion
2022-09-14
Completion
2022-09-14
FDA Drug
Yes

Countries

  • United States
  • Chile
  • Colombia
  • South Africa
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03524118 on ClinicalTrials.gov