Clinical Trial

A Phase I Study to Evaluate the Safety/Tolerability of BDHK-2009 Tablets in Healthy Adult

Name: A Phase I Study to Evaluate the Safety/Tolerability of BDHK-2009 Tablets in Healthy Adult — clinical trial record (NCT07632573)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Recruiting Phase 1

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Summary

A Phase 1, 2-part, randomised, double-blind, placebo-controlled, FIH study to determine the safety, tolerability, and PK of single, ascending oral doses (SAD) of BDHK-2009 (Part 1) and multiple oral doses (Part 2) of BDHK-200 in healthy adult participants.

Trial Details

NCT Number	NCT07632573
Lead Sponsor	Benethera (Shaoxing) Biotechnology Co., Ltd.
Conditions	Ulcerative Colitis (UC), Ulcerative Colitis (Disorder), Ulcerative Colitis Acute, IBD (Inflammatory Bowel Disease), CD - Crohn's Disease
Enrollment	68 participants
Start Date	2026-05-18
Primary Completion	2026-12-31 (estimated)
Study Completion	2027-02-28 (estimated)
Updated on ClinicalTrials.gov	2026-06-08