A Phase 1 interventional study of SHR-7590 and Placebo in Moderate-to-severe Inflammatory Bowel Disease, sponsored by Guangdong Hengrui Pharmaceutical Co., Ltd. Recruiting at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Guangdong Hengrui Pharmaceutical Co., Ltd (part of Jiangsu HengRui Medicine Co., Ltd.) · Phase 1, Interventional, and Treatment
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.
Guangdong Hengrui Pharmaceutical Co., Ltd is the lead sponsor of 59 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
- Part 1
Exclusion Criteria:
- Part 1
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subject will receive SHR-7590 at dose level A. Subject will receive placebo at dose level A.
Drug: SHR-7590 · Drug: Placebo
Subject will receive SHR-7590 at dose level B. Subject will receive placebo at dose level B.
Drug: SHR-7590 · Drug: Placebo
Subject will receive SHR-7590 at dose level C. Subject will receive placebo at dose level C.
Drug: SHR-7590 · Drug: Placebo
Subject will receive SHR-7590 at dose level D. Subject will receive placebo at dose level D.
Drug: SHR-7590 · Drug: Placebo
Subject will receive SHR-7590 at dose level E. Subject will receive placebo at dose level E.
Drug: SHR-7590 · Drug: Placebo
SHR-7590
Placebo
Adverse events
Time frame: From ICF signing date to Day 281
Serious adverse events
Time frame: From ICF signing date to Day 281
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
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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