Moderate-to-severe Inflammatory Bowel DiseasePhase 1NCT07758101
A Study to Evaluate the Safety of SHR-7590 in Chinese Healthy Participants and in Patients With Moderate-to-severe Inflammatory Bowel Disease
A Phase 1 study testing SHR-7590 in people with Moderate-to-severe Inflammatory Bowel Disease, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Moderate-to-severe Inflammatory Bowel Disease
- What is being tested?
- SHR-7590
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 21 Aug 2026to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Bo Jiang
About this study
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)
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.
- Being tested
- SHR-7590, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-7590Drug
SHR-7590
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Dose Level：A | Experimental | Subject will receive SHR-7590 at dose level A. Subject will receive placebo at dose level A. Receives: Drug: SHR-7590; Drug: Placebo |
| Dose Level：B | Experimental | Subject will receive SHR-7590 at dose level B. Subject will receive placebo at dose level B. Receives: Drug: SHR-7590; Drug: Placebo |
| Dose Level：C | Experimental | Subject will receive SHR-7590 at dose level C. Subject will receive placebo at dose level C. Receives: Drug: SHR-7590; Drug: Placebo |
| Dose Level：D | Experimental | Subject will receive SHR-7590 at dose level D. Subject will receive placebo at dose level D. Receives: Drug: SHR-7590; Drug: Placebo |
| Dose Level：E | Experimental | Subject will receive SHR-7590 at dose level E. Subject will receive placebo at dose level E. Receives: Drug: SHR-7590; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: From ICF signing date to Day 281
Serious adverse events
Measured: From ICF signing date to Day 281
Secondary outcomes (8)
Maximum observed concentration of SHR-7590 (Cmax)
Measured: From 0 hour date to Day 281
Time to maximum observed concentration (Tmax) of SHR-7590
Measured: 0 hour to Day 281
Area under the drug-time curve from 0 to the last quantifiable time point (AUC0-last) of SHR-7590
Measured: 0 hour to Day 281
Area under the drug-time curve from time 0 to infinity of SHR-7590（AUC0-inf）
Measured: 0 hour to Day 281
Half-life (T1/2) of SHR-7590
Measured: 0 hour to Day 281
Clearance (CL) of SHR-7590
Measured: 0 hour to Day 281
Apparent clearance（CL/F）of SHR-7590
Measured: 0 hour to Day 281
Volume of distribution （Vd）or apparent volume of distribution （Vd/F）of SHR-7590
Measured: 0 hour to Day 281
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start21 Aug 2026
- Primary completionJan 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate-to-severe Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07758101
- Sponsor's protocol ID
- SHR-7590-101
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- SHR-7590-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 21 Aug 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dose Level：A | Experimental | Drug: SHR-7590, Drug: PlaceboSubject will receive SHR-7590 at dose level A. Subject will receive placebo at dose level A. |
| Dose Level：B | Experimental | Drug: SHR-7590, Drug: PlaceboSubject will receive SHR-7590 at dose level B. Subject will receive placebo at dose level B. |
| Dose Level：C | Experimental | Drug: SHR-7590, Drug: PlaceboSubject will receive SHR-7590 at dose level C. Subject will receive placebo at dose level C. |
| Dose Level：D | Experimental | Drug: SHR-7590, Drug: PlaceboSubject will receive SHR-7590 at dose level D. Subject will receive placebo at dose level D. |
| Dose Level：E | Experimental | Drug: SHR-7590, Drug: PlaceboSubject will receive SHR-7590 at dose level E. Subject will receive placebo at dose level E. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-7590SHR-7590 | Drug | Dose Level：A, Dose Level：B, Dose Level：C, Dose Level：D, Dose Level：E |
| PlaceboPlacebo | Drug | Dose Level：A, Dose Level：B, Dose Level：C, Dose Level：D, Dose Level：E |
Primary outcome
Adverse events
Time frame: From ICF signing date to Day 281
Serious adverse events
Time frame: From ICF signing date to Day 281
8 secondary outcomes
Maximum observed concentration of SHR-7590 (Cmax)
Time frame: From 0 hour date to Day 281
Time to maximum observed concentration (Tmax) of SHR-7590
Time frame: 0 hour to Day 281
Area under the drug-time curve from 0 to the last quantifiable time point (AUC0-last) of SHR-7590
Time frame: 0 hour to Day 281
Area under the drug-time curve from time 0 to infinity of SHR-7590（AUC0-inf）
Time frame: 0 hour to Day 281
Half-life (T1/2) of SHR-7590
Time frame: 0 hour to Day 281
Clearance (CL) of SHR-7590
Time frame: 0 hour to Day 281
Apparent clearance（CL/F）of SHR-7590
Time frame: 0 hour to Day 281
Volume of distribution （Vd）or apparent volume of distribution （Vd/F）of SHR-7590
Time frame: 0 hour to Day 281
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR-7590 in people with Moderate-to-severe Inflammatory Bowel Disease, run by Guangdong Hengrui Pharmaceutical Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Si Chen (0518-82342973, si.chen@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: From ICF signing date to Day 281). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.