RecruitingPhase 1NCT07632573

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

A Phase I Clinical Study to Evaluate the Safety/Tolerability, Pharmacokinetics/Pharmacodynamics of BDHK-2009 Tablets in Healthy Adult Participants: a Randomized, Double-blind, Placebo-controlled, Single-dose/Multiple-dose Escalation Study.

Sponsor

Benethera (Shaoxing) Biotechnology Co., Ltd.

Enrollment

68 participants

Start Date

May 18, 2026

Study Type

INTERVENTIONAL

Conditions

IBD (Inflammatory Bowel Disease)Ulcerative Colitis (UC)CD - Crohn's Disease Ulcerative Colitis (Disorder)Ulcerative Colitis Acute

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.

Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called BDHK-2009 Tablets and a drug called Placebo for people with cd - crohn's disease, ibd (inflammatory bowel disease), and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 55 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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