Ignite Creation Date:
2024-05-06 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 12:45 PM
Study NCT ID:
NCT03524118
Status:
COMPLETED
Last Update Posted:
2023-11-29
First Post:
2018-05-11
Brief Title:
Safety Tolerability and Pharmacokinetics of Clesrovimab MK-1654 in Infants MK-1654-002
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-005062-21 | EUDRACT_NUMBER | Merck Protocol Number | None |
| MK-1654-002 | OTHER | None | None |