Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HBS-104 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Crossover: HBS-104 Low Dose | EXPERIMENTAL | Participants will receive a single oral low dose of HBS-104. |
| Crossover: HBS-104 Medium Dose | EXPERIMENTAL | Participants will receive a single oral medium dose of HBS-104. |
| Crossover: HBS-104 High Dose | EXPERIMENTAL | Participants will receive a single oral high dose of HBS-104. |
| Crossover: Placebo | ACTIVE_COMPARATOR | Participants will receive a single oral dose of placebo. |
| Name | Type | Description |
|---|---|---|
| HBS-104 | DRUG | Immediate-release tablets for oral use |
| Placebo | DRUG | Matching placebo tablet |
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 ...
HBS-104 is an investigational small molecule being developed by Harmony Biosciences Holdings, Inc. for sleep deprivation. It is in Phase 1 clinical development and is not approved for any use. The program is being studied in healthy adult volunteers who are acutely sleep deprived.
HBS-104 is being studied for sleep deprivation. The only clinical trial of HBS-104 to date enrolls acutely sleep-deprived healthy participants, and the drug remains investigational. No approved indication exists for HBS-104, and its use is currently limited to clinical research.
HBS-104 is being developed by Harmony Biosciences Holdings, Inc., which trades on the Nasdaq under the ticker HRMY. Harmony Biosciences is the sponsor of the HBS-104 clinical program, including the ongoing Phase 1 study in acutely sleep-deprived healthy participants.
HBS-104 is in Phase 1 clinical development. One Phase 1 trial has been initiated and is currently recruiting; no Phase 1 trial of HBS-104 has been completed. HBS-104 is investigational and has not been approved by the FDA for any indication.
HBS-104 is being evaluated in a single Phase 1 trial, NCT07848659, titled "Study of Single Doses of HBS-104 in Acutely Sleep-deprived Healthy Participants." The trial is recruiting in the United States, plans to enroll 12 healthy adult volunteers, and uses a randomized, double-blind, active-controlled design.