Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-01-01 @ 3:43 PM
Study NCT ID:
NCT07229950
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-17
First Post:
2025-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 2 Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HRS-7085 Tablets in Patients With Inflammatory Bowel Disease
Sponsor:
Shandong Suncadia Medicine Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase 2 Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HRS-7085 Tablets in Patients With Inflammatory Bowel Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a randomized, double-blind, placebo-controlled Phase II clinical trial comprising screening period, treatment period, and follow-up period. This phase 2 study is being conducted to evaluate the efficacy, safety and pharmacokinetics of HRS-7085 in patients with moderate to severe active ulcerative colitis.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: