A Trial of HRS-7085 Tablets in Patients With Moderate to Severe Active Ulcerative Colitis

NCT07760831 | Not Yet Recruiting Phase 1

• 1 other identifier: HRS-7085-202
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The study is being conducted to evaluate the safety, tolerability and pharmakokinetics of HRS-7085 in adults.

Conditions

Moderate to Severe Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Adverse events (AEs)

  at Week 12

Secondary Outcomes (24)

• AUClast,

  Day 1

• Tmax,

  Day 1

• Cmax,

  Day 1

• AUC0-inf,

  Day 1

• AUCtau,

  Day 1

Study Arms (2)

Active treatment of HRS-7085 from Week 1-Week 12

EXPERIMENTAL

Drug: HRS-7085 tablets

Placebo from Week 1-Week 12

PLACEBO COMPARATOR

Drug: Placebo

Interventions

HRS-7085 tablets DRUG

HRS-7085 tablets

Active treatment of HRS-7085 from Week 1-Week 12

Placebo DRUG

HRS-7085 tablet blank preparation

Placebo from Week 1-Week 12

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years old and not more than 75 years old at the time of signing the Informed Consent Form (ICF), regardless of their sex.
• Body mass index \[BMI = weight (kg)/height2(m2)\] ≥ 18 kg/m2 at screening.
• Participants with active UC who have a modified 9-point Mayo score of 5 to 9 and an endoscopic subscore of 2 to 3 at baseline (the interval between screening endoscopy and baseline cannot exceed 14 days), with a rectal bleeding subscore of at least 1.
• At the time of first dose, the participant is diagnosed with UC for at least 90 days, and UC is confirmed by investigation during the screening visit.
• The investigator considers that the participant has an inadequate response, loss of response, or intolerance to conventional therapy (oral 5-ASA, immunomodulators, or corticosteroids), anti-tumor necrosis factor (TNF) or other biologic therapy, JAK inhibitor therapy, or is unable to receive these treatments for other reasons.
• Note: definitions of insufficient response, loss of response, or intolerance are provided in Appendix 13.5.
• If the participant is currently receiving the following UC therapy at screening, a stable dosage should be administered within the specified time:
• Oral 5-ASA (mesalazine) (with stable dosage at least 2 weeks before baseline and during the study treatment period), AND/OR
• Oral corticosteroids (prednisone or prednisolone ≤ 20 mg/day) (with stable dosage for at least 2 weeks prior to baseline and during the treatment period). All other systemic corticosteroid routes are prohibited.
• The participant voluntarily signs the Informed Consent Form (ICF) before any study-related procedures, can communicate smoothly with the investigator, understands and is willing to strictly comply with the requirements of this clinical study protocol to complete the study.
• Women of childbearing potential must agree to use highly effective contraceptive methods during the trial and within 3 months after the last dose of trial intervention. Serum or urine pregnancy tests must be negative before and during the trial. Females who are lactating are not eligible to participate in the trial (see Section 13.1 for details). Males must use highly effective contraceptive methods during the trial and within 3 months after the last dose of trial intervention during intercourse with a female of childbearing potential. Donation of sperm during this period is prohibited.

You may not qualify if:

• Any of the following medical histories or concomitant diseases:
• Participants clinically diagnosed with unclassified colitis or suggestive of Crohn's disease.
• Participants with UC, limited to proctitis (distal ≤15 cm).
• Participants diagnosed with UC who are treatment-naive (no prior treatment received).
• Participants presenting with clinical symptoms of ischemic colitis, fulminant colitis, or toxic megacolon.
• Participants who have previously undergone surgery for UC or might require surgery during the study phase.
• Screening investigation finds that the participant has a medical history of gastrointestinal dysplasia (atypical hyperplasia)/cancer or dysplasia (atypical hyperplasia)/cancer. Completely resected low-grade dysplasia will be excluded.
• Participants with a positive Clostridium difficile (C. difficile) test at screening may be enrolled only if they have:
• Completed appropriate standard-of-care treatment for C. difficile infection;
• Achieved clinical resolution of diarrheal symptoms; AND
• A documented negative repeat stool test (toxin A/B assay or NAAT/PCR) conducted after completion of treatment and within 7-14 days prior to baseline/randomization.
• Participants with evidence of other intestinal infections within 30 days of endoscopic screening, or other intestinal pathogen screening.
• The participant has or previously had:
• Clinically significant infection (e.g., requiring hospitalization or parenteral antimicrobial therapy or opportunistic infection) within 1 month before baseline.
• History of herpes zoster occurring twice or more, or herpes zoster disseminated (occurring once).

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

IMSP Republican Clinical Hospital "Timofei Mosneaga", Clinical Trial Unit ARENSIA EXPLORATORY MEDICINE

Chisinau, Chișinău Municipality, MD-2025, Moldova

Location

Central Study Contacts

ChuiFung Chong

CONTACT

+41794768792; Chuifung.chong@luzsana.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 12, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 12, 2026

Record last verified: 2026-07

Locations

MO (1)