drugset / Trial / NCT05848453
Safety, Tolerability, and Pharmacokinetics of BAP5191 in Healthy Adults Following Topical Application of Repeat Doses
Phase 1
Completed
24 enrolled
Bacoba AG
Swiss TPH, Basel, Switzerland · collabUniversity Hospital, Basel, Switzerland · collab
RandomizedSequentialDouble-blindScreening
Summary
All enrolled participants will be randomized to 3 cohorts with 8 participants each and will receive BAP5191 and placebo topically on a square of 121 cm2 each in the left and right scapula region daily for 28 days, with a 28-d safety follow-up. The squares will be covered with a semi-occlusive patch. The doses will escalate from Cohort 1 to Cohort 2 to Cohort 3.
Timeline
- Start
- 2023-03-28
- Primary completion
- 2024-03-07
- Completion
- 2024-03-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BAP5191 | Unknown | 1 mg/ml | Topical |
| Subject | BAP5191 | Unknown | 5 mg/ml | Topical |
| Subject | BAP5191 | Unknown | 10 mg/ml | Topical |
Indications
No indication recorded.