HBS-104 single doses in acutely sleep-deprived healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1, randomized, double-blind crossover trial will compare low, medium, and high oral doses of HBS-104 to placebo in healthy adults who are acutely sleep-deprived. Participants receive a single dose during each of four treatment periods (Days -1 to 3) with 7–12 days between periods to wash out the drug. The study assesses pharmacodynamic effects, safety, tolerability, and pharmacokinetics after dosing under sleep-deprived conditions. A single-site sponsor clinical location in Eatontown, New Jersey conducts all procedures.

Why it matters

Who can join: the full rules

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

Where it's running

• Sponsor Clinical Site - New Jersey
  Eatontown, New Jersey, United States Recruiting

Study contacts

• Study coordinator: Clinical Trials Administrator
• Email: clinicaltrials@harmonybiosciences.com
• Phone: see email

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.