drugset / Trial / NCT05391880

Study of Orally Administered BEBT-503 in Healthy Subjects

NCT05391880 ↗

Phase 1 Completed 57 enrolled BeBetter Med Inc
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

EvaluationDrugModalityDoseRoute
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.