A Study to Evaluate the Safety of SHR-7590 in Chinese Healthy Participants and in Patients With Moderate-to-severe Inflammatory Bowel Disease
Phase 1 · Testing SHR-7590 · 1 site · Guangdong Hengrui Pharmaceutical Co., Ltd
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing SHR-7590 (a drug) as a possible treatment. Condition(s) listed: Moderate-to-severe Inflammatory Bowel Disease.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
Phase 1 studies are early tests in a small group of people, mainly checking safety and dosing.
Who can join
- Ages 18 to 55
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- \- Part 1
- Voluntarily signed the informed consent form
- Age from 18 to 55 years old
- Body weight ≥45 kg, body mass index (BMI) 18-26 kg/m2
- Normal or clinically insignificant vital signs, physical examination, laboratory examination and other examinations
- Adopt efficient contraceptive measures
There are also 11 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 88 participants are expected to take part.
- The study has 5 groups.
- Start date: 2026-08-21.
- Main results expected around 2027-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in China.
Groups in this study
- Dose Level：A (listed as: experimental group)
- Dose Level：B (listed as: experimental group)
- Dose Level：C (listed as: experimental group)
- Dose Level：D (listed as: experimental group)
- Dose Level：E (listed as: experimental group)
Main thing being measured
- Adverse events (From ICF signing date to Day 281)
- Serious adverse events (From ICF signing date to Day 281)
In the researchers’ words
This Phase I first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SHR-7590 via subcutaneous or intravenous administration in Chinese healthy participants and patients with moderate-to-severe inflammatory bowel disease.
Words you might see
- Placebo: a look-alike pill or injection with no active drug, used for comparison.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 1 |
| Study type | Interventional |
| Conditions | Moderate-to-severe Inflammatory Bowel Disease |
| Lead sponsor | Guangdong Hengrui Pharmaceutical Co., Ltd |
| Enrollment | 88 (estimated) |
| Start date | 2026-08-21 |
| Primary completion (est.) | 2027-01 |
| First posted | 2026-08-11 |
| Last updated | 2026-09-25 |
| Official title | A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Injection or Intravenous Infusion of SHR-7590 Injection in Healthy Chinese Participants and Participants With Moderate-to-Severe Inflammatory Bowel Disease (Ulcerative Colitis and Crohn's Disease) |
| ClinicalTrials.gov ID | NCT07758101 |
Interventions
- SHR-7590 (Drug)
SHR-7590 - Placebo (Drug)
Placebo
Full eligibility criteria (from the record)
Inclusion Criteria: \- Part 1 * Voluntarily signed the informed consent form * Age from 18 to 55 years old * Body weight ≥45 kg, body mass index (BMI) 18-26 kg/m2 * Normal or clinically insignificant vital signs, physical examination, laboratory examination and other examinations * Adopt efficient contraceptive measures Exclusion Criteria: \- Part 1 * Suspected allergy to the study drug or any component of the study drug * Any clinical disease or any other disease that could interfere with the test results * Had a history of malignant tumor * Had an opportunistic infection within 6 months before screening * Acute infection with constitutional symptoms within 4 weeks before baseline * Participants who participated in any drug or device clinical trial within 3 months before screening * Use of any drug within 1 month before the use of the investigational drug * Patients who had used immunosuppressant or anti-interleukin antibody drugs within 6 months before screening * Had major trauma or major surgery within 6 months before screening, or were scheduled to undergo surgery during the trial * History of blood donation within 1 month before screening, or severe blood loss
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| The Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou, Zhejiang | China | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.