NCT07848659 Study of Single Doses of HBS-104 in Acutely Sleep-deprived Healthy Participants
| NCT ID | NCT07848659 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Harmony Biosciences Management, Inc. |
| Condition | Sleep Deprivation |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2026-08-28 |
| Primary Completion | 2026-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2026-08-28 with a primary completion date of 2026-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
David Sneiden, MD
STUDY DIRECTOR
Harmony Biosciences Management, Inc.
Frequently Asked Questions
Who can join the NCT07848659 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Sleep Deprivation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07848659 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07848659 currently recruiting?
Yes, NCT07848659 is actively recruiting participants. Contact the research team at clinicaltrials@harmonybiosciences.com for enrollment information.
Where is the NCT07848659 trial being conducted?
This trial is being conducted at Eatontown, United States.
Who is sponsoring the NCT07848659 clinical trial?
NCT07848659 is sponsored by Harmony Biosciences Management, Inc.. The principal investigator is David Sneiden, MD at Harmony Biosciences Management, Inc.. The trial plans to enroll 12 participants.