NCT05502549

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CB03-154 in Healthy Participants in Australia

A Randomized, Double-Blind, Placebo-Controlled, Phase I Study to Evaluate the Safety, Tolerability,and Pharmacokinetics of Single and Multiple Ascending Oral Doses of CB03-154 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Shanghai Zhimeng Biopharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

CB03-154 is an investigational drug developed by Shanghai Zhimeng Biopharma Inc. for the treatment of Epilepsy.

Detailed description

The purpose of this study is to see how safe the study drug is and how well it is tolerated after dosing. The study will also test how the study drug is taken up and eliminated by the body. An additional part of the study is to look at how this could be changed by giving the study drug with food.And identify and characterize metabolite of investigational product(s).

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	CB03-154	CB03-154 tablet once daily.
DRUG	Placebo	Placebo tablet once daily.

Timeline

• Start date: 2022-11-29
• Primary completion: 2023-11-09
• Completion: 2023-12-15
• First posted: 2022-08-16
• Last updated: 2024-02-01

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study