Safety, Tolerability, and Pharmacokinetics of Clesrovimab (MK-1654) in Infants (MK-1654-002)
Public ClinicalTrials.gov record NCT03524118. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT03524118
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 183 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 2 Weeks to 8 Months
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 20, 2018 (Actual)
- Primary completion
- Sep 14, 2022 (Actual)
- Completion
- Sep 14, 2022 (Actual)
- Last update posted
- Jan 14, 2025
2018 – 2022
United States locations
- U.S. sites
- 17
- U.S. states
- 13
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital - Colorado ( Site 0067) | Aurora | Colorado | 80045 | — |
| Next Phase Research Alliance, LLC ( Site 0075) | Homestead | Florida | 33030 | — |
| Acevedo Clinical Research Associates ( Site 0025) | Miami | Florida | 33142 | — |
| Kapiolani Medical Center for Women and Children ( Site 0027) | Honolulu | Hawaii | 96826 | — |
| Cotton-O'Neil Clinical Research Center PediatricCare ( Site 0081) | Topeka | Kansas | 66604 | — |
| Children's Mercy Hospital ( Site 0037) | Kansas City | Missouri | 64108 | — |
| Dartmouth-Hitchcock Medical Center ( Site 0032) | Lebanon | New Hampshire | 03766 | — |
| SUNY Upstate Medical University Hospital ( Site 0029) | Syracuse | New York | 13210 | — |
| WakeMed Health and Hospitals ( Site 0033) | Raleigh | North Carolina | 27610 | — |
| Cincinnati Children's Hospital Medical Center ( Site 0031) | Cincinnati | Ohio | 45229 | — |
| Ohio Pediatric Research Association ( Site 0066) | Dayton | Ohio | 45414 | — |
| Coastal Pediatric Research ( Site 0028) | Charleston | South Carolina | 29414 | — |
| Tribe Clinical Research, LLC ( Site 0082) | Greenville | South Carolina | 29607 | — |
| University of Texas Medical Branch at Galveston ( Site 0039) | Galveston | Texas | 77555 | — |
| Tekton Research, Inc. ( Site 0026) | San Antonio | Texas | 78240 | — |
| Multicare Institute For Research And Innovation ( Site 0035) | Tacoma | Washington | 98405 | — |
| University of Wisconsin American Family Children's Hospital ( Site 0068) | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 17 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03524118, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 14, 2025 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03524118 live on ClinicalTrials.gov.