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NCT03524118 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, and Pharmacokinetics of Clesrovimab (MK-1654) in Infants (MK-1654-002)
A Phase 1 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 1
- Development phase
- 183
- Enrollment target
NCT03524118: Completed Phase 1 study, sponsored by Merck Sharp & Dohme.
NCT03524118 is a Phase 1 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 183 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (205% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03524118, a Phase 1 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 183 participants
- Enrollment target
Study 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.
Primary Outcome
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection site AEs were monitored from Day 1 to Day 5.
Interventions
- DRUG Placebo
- DRUG Clesrovimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 183 participants |
| Start Date | 2018-09-20 |
| Est. Completion | 2022-09-14 |
| Phase | Phase 1 |
What the finished NCT03524118 record still lists
NCT03524118 is an interventional study that assigns participants to a tested intervention. The registered 183 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (205% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03524118 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03524118 about?
NCT03524118 is a clinical study titled "Safety, Tolerability, and Pharmacokinetics of Clesrovimab (MK-1654) in Infants (MK-1654-002)". 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. Particip...
What is the current status of trial NCT03524118?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 183 participants. The study started on 2018-09-20. Estimated completion is 2022-09-14.
What interventions are being tested in trial NCT03524118?
The interventions under investigation include: Placebo (DRUG), Clesrovimab (DRUG).
Who is sponsoring clinical trial NCT03524118?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03524118's enrollment target sits among peer trials
183 297th of 2000 higher than 1,702 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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