Recruiting
Phase 1

HBS-104

Sponsor:

Harmony Biosciences Management, Inc.

Code:

NCT07848659

Conditions

Sleep Deprivation

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

HBS-104

Placebo

Study Details

Brief summary:

This is a study to evaluate the pharmacodynamic effects, safety, tolerability, and pharmacokinetics of HBS-104 in acutely sleep-deprived healthy adult participants.

Conditions

Sleep Deprivation

Study ID

NCT07848659

Start date

Aug 28, 2026

Status verified date

Sep, 2026

Completion date

Feb 18, 2027

Anticipated

Primary completion date

Oct 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

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

Study Design

Enrollment

12 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Crossover: HBS-104 Low Dose

Participants will receive a single oral low dose of HBS-104.

experimental: Crossover: HBS-104 Medium Dose

Participants will receive a single oral medium dose of HBS-104.

experimental: Crossover: HBS-104 High Dose

Participants will receive a single oral high dose of HBS-104.

active comparator: Crossover: Placebo

Participants will receive a single oral dose of placebo.

Interventions

HBS-104

Immediate-release tablets for oral use

Placebo

Matching placebo tablet

Primary outcome measure

  • Mean Sleep Latency as Assessed by Maintenance of Wakefulness Test (MWT) [ Time Frame: Day 2 of each treatment period (each treatment period is 4 days in duration [Days -1 to 3]). ]
  • Karolinska Sleepiness Scale (KSS) Score [ Time Frame: 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 [ Time Frame: Days 1 and 2 of each treatment period (each treatment period is 4 days in duration [Days -1 to 3]). ]

Central Contacts and Locations

Central contacts

Clinical Trials Administrator

see emailclinicaltrials@harmonybiosciences.com

Locations

Sponsor Clinical Site - New Jersey

Recruiting

Eatontown, New Jersey, United States, 07724

More Information

Sponsor

Harmony Biosciences Management, Inc.

Last update posted

Sep 30, 2026

Last verified

Sep, 2026

Keywords

  • Healthy Participants
  • Acute Sleep Deprivation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-01. This information was provided to ClinicalTrials.gov by Harmony Biosciences Management, Inc. on 2026-09-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.