Safety, Tolerability, and Pharmacokinetics of MK-1654 in Infants (MK-1654-002)
Status:
Active, not recruiting
Trial end date:
2022-09-13
Target enrollment:
Participant gender:
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 MK-1654 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.