This is a study to evaluate the pharmacodynamic effects, safety, tolerability, and pharmacokinetics of HBS-104 in acutely sleep-deprived healthy adult participants.
Eligibility
Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
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
Primary outcome measure(s)
Mean Sleep Latency as Assessed by Maintenance of Wakefulness Test (MWT) — Day 2 of each treatment period (each treatment period is 4 days in duration [Days -1 to 3]).
Karolinska Sleepiness Scale (KSS) Score — Days 1 and 2 of each treatment period (each treatment period is 4 days in duration [Days -1 to 3]).
Psychomotor Vigilance Test (PVT) Score — Days 1 and 2 of each treatment period (each treatment period is 4 days in duration [Days -1 to 3]).
Trial sites (1)
Facility
City
Region
Status
Sponsor Clinical Site - New Jersey
Eatontown
New Jersey
Recruiting
More Harmony Biosciences Management, Inc. trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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