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NCT07051252 · ClinicalTrials.gov registry record · Phase 1
A Study of HBS-201 (Pitolisant Delayed-release)
A Phase 1 study, sponsored by Harmony Biosciences Management.
- Completed
- Registry status
- Phase 1
- Development phase
- 46
- Enrollment target
NCT07051252: Completed Phase 1 study, sponsored by Harmony Biosciences Management.
NCT07051252 is a Phase 1 study that has completed, run by Harmony Biosciences Management. The registered enrollment target is 46 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07051252, a Phase 1 study, has completed, sponsored by Harmony Biosciences Management.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 46 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the tolerability of HBS-201 when starting at a therapeutic dose in adult participants with narcolepsy.
Primary Outcome
A TEAE is any adverse event (AE) reported after the first dose of study drug, or any worsening of a pre-existing condition reported after first dose of study drug.
Interventions
- DRUG HBS-201
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2025-05-21 |
| Est. Completion | 2025-10-13 |
| Phase | Phase 1 |
What the finished NCT07051252 record still lists
NCT07051252 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 1 intervention - of which HBS-201 is the first listed.
NCT07051252 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07051252 about?
NCT07051252 is a clinical study titled "A Study of HBS-201 (Pitolisant Delayed-release)". The purpose of this study is to assess the tolerability of HBS-201 when starting at a therapeutic dose in adult participants with narcolepsy.
What is the current status of trial NCT07051252?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2025-05-21. Estimated completion is 2025-10-13.
What interventions are being tested in trial NCT07051252?
The interventions under investigation include: HBS-201 (DRUG).
Who is sponsoring clinical trial NCT07051252?
This trial is sponsored by Harmony Biosciences Management, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07051252's enrollment target sits among peer trials
46 1058th of 2000 higher than 935 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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