Clinical Trial of TQH3906 Capsules for the Treatment of Adult Patients With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease

Recruiting Phase 1 Interventional Study
Inflammatory Bowel Diseases
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
135 (estimated)
Sponsor
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Industry
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About This Trial
This phase will commence following dose escalation in the 24mg bid group during Phase I. Employing a 1:1:1 randomized, double-blind, placebo-controlled study design, it will evaluate the efficacy, safety, and Pharmacokinetics/Pharmacodynamics (PK/PD) characteristics of TQH3906 capsules in subjects with moderate-to-severe active ulcerative colitis. The study will include a maximum 4-week screening …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Age between 18-75 years (inclusive of both 18 and 75), regardless of gender. * Diagnosed with ulcerative colitis or Crohn's disease for ≥3 months, as assessed by histological or endoscopic examination prior to screening. * Active moderate to severe UC or CD. * Subjects must ha…
Contacts

Xiaowei Liu, Postdoctoral researcher

13548762632

liuxw@csu.edu.cn

CONTACT