drugset / Trial / NCT05391880
Study of Orally Administered BEBT-503 in Healthy Subjects
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a Phase I, randomized, double-blind, placebo-controlled, first-in-human study in which the safety, tolerability, and pharmacokinetic of orally administered BEBT-503 will be assessed in healthy adult subjects. The study will consist of 2 parts: a SAD phase (Part A) enrolling a total of 5 cohorts of healthy subjects; a MAD phase (Part B) enrolling 2 cohorts of healthy subjects; One cohort of Part A will receive BEBT-503 under both fasted and fed conditions to investigate the effect of food
Timeline
- Start
- 2022-08-26
- Primary completion
- 2023-05-29
- Completion
- 2023-07-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BEBT-503 | Unknown | 20 mg | — |
| Subject | BEBT-503 | Unknown | 40 mg | — |
| Subject | BEBT-503 | Unknown | 80 mg | — |
| Subject | BEBT-503 | Unknown | 120 mg | — |
| Subject | BEBT-503 | Unknown | 180 mg | — |
Indications
No indication recorded.