NCT05391880

Study of Orally Administered BEBT-503 in Healthy Subjects

A Randomized, Double-Blind, Placebo-Controlled Study of Orally Administered BEBT-503 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses (SAD) and Multiple Ascending Doses (MAD) in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: BeBetter Med Inc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	BEBT-503 20mg	BEBT-503 capsule
DRUG	BEBT-503 40mg	BEBT-503 capsule
DRUG	BEBT-503 80mg	BEBT-503 capsule
DRUG	BEBT-503 120mg	BEBT-503 capsule
DRUG	BEBT-503 180mg	BEBT-503 capsule
DRUG	placebo 20mg	placebo capsule
DRUG	placebo 40mg	placebo capsule
DRUG	placebo 80mg	placebo capsule
DRUG	placebo 120mg	placebo capsule
DRUG	placebo 180mg	placebo capsule

Timeline

• Start date: 2022-08-26
• Primary completion: 2023-05-29
• Completion: 2023-07-05
• First posted: 2022-05-26
• Last updated: 2023-09-18

Locations

1 site across 1 country: Australia