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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 is a Phase 1 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 183 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03524118
The ClinicalTrials.gov registry entry for NCT03524118 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 183 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03524118 reports 0 study locations.
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.
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