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

Sponsor
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Study ID
NCT06754891
Phase
PHASE1
Status
Recruiting
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Conditions

  • Inflammatory Bowel Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 24mg bid TQH3906 capsule — DRUG
    TQH3906 is an allosteric inhibitor targeting kinase developed by Chia Tai Tianqing Pharmaceutical Co., Ltd.
  • 32mg TQH3906 capsule — DRUG
    TQH3906 is an allosteric inhibitor targeting kinase developed by Chia Tai Tianqing Pharmaceutical Co., Ltd.
  • TQH3906 placebo — DRUG
    TQH3906 is an allosteric inhibitor targeting kinase developed by Chia Tai Tianqing Pharmaceutical Co., Ltd.

Study Details

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 period, a 12-week treatment period, and a 4-week post-treatment follow-up period, enrolling a total of 105 subjects. Among these, subjects who failed conventional therapy and those who failed biologic therapy each constitute 35% of the cohort. week treatment period, and a 4-week post-treatment follow-up period. A total of 105 subjects will be enrolled, with 50% comprising subjects who failed conventional therapy and 50% comprising subjects who failed biologic therapy. Dose Group Design: Group A: Placebo Group B: 32mg dose group Group C: 24mg bid dose group The specific dose will be determined based on the 48mg dose group's medication experience from Phase I and adjusted as necessary.

Key Dates

First listed
Jan 1, 2025
Start date
Jan 28, 2025
Status verified
May 2026
Primary completion
Jul 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
135 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 24mg bid TQH3906 capsule treatment group
    24mg TQH3906 capsules for 12 weeks
  • Experimental: 32mg TQH3906 capsule treatment group
    32mg TQH3906 capsules for 12 weeks
  • Experimental: TQH3906 placebo treatment group
    Placebo Comparator

Primary Outcome Measure

Adverse event rate [ Time Frame: Baseline up to week 16 ]

Central Contacts

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