A Trial of HRS-7085 Tablets in Patients With Moderate to Severe Active Ulcerative Colitis
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJiangsu HengRui Medicine Co., Ltd.
About this trial
The study is being conducted to evaluate the safety, tolerability and pharmakokinetics of HRS-7085 in adults.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- HRS-7085 tablets
- Placebo
Treatment groups
8 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov