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

NCT07632573 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2026-06-08

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

BDHK-2009 Tablets

Administration: Oral

DRUG

Placebo

Administration: Oral

Sponsors & Collaborators

  • Benethera (Shaoxing) Biotechnology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jinliang Chen · Zhejiang Xiaoshan hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-18
Primary Completion
2026-12-31
Completion
2027-02-28

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07632573 on ClinicalTrials.gov