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Recruiting
NCT07848659
Study of Single Doses of HBS-104 in Acutely Sleep-deprived Healthy Participants
Conditions: Sleep Deprivation
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 12
Sponsor: Harmony Biosciences Management, Inc.
Location: Sponsor Clinical Site - New Jersey Eatontown New Jersey
Summary
This is a study to evaluate the pharmacodynamic effects, safety, tolerability, and pharmacokinetics of HBS-104 in acutely sleep-deprived healthy adult participants.
Eligibility Criteria
Inclusion Criteria:
* Provide written informed consent before any study-related procedures are performed.
* Be healthy as determined by assessments at the Screening Visit.
Exclusion Criteria:
* Female with a positive pregnancy test at Screening Visit or upon check-in for Period 1.
* Is currently breastfeeding or planning to breastfeed over the course of the study. Lactating women must agree not to breastfeed for the duration of the study and for 7 days after their final dose of study drug.
Note: Additional inclusion/exclusion criteria may apply, per protocol
Source: ClinicalTrials.gov (NCT07848659). StuddyBuddy aggregates publicly available trial information.
