Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Could a new injection tame ulcerative colitis?

NCT ID NCT07758101

Disease control Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This early-stage trial is testing an experimental drug called SHR-7590 to see if it is safe and tolerable when given by injection under the skin or into a vein. It involves healthy volunteers and people with moderate-to-severe ulcerative colitis, a condition that causes inflammation and sores in the colon. The study will also look at how the drug moves through the body and how it affects the disease. The goal is to gather initial information that could support further development of SHR-7590 as a potential treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SHR-7590, an experimental drug given by injection under the skin or into a vein
What this could lead to
If safe and effective, SHR-7590 could become a new treatment option to control inflammation and reduce symptoms in people with ulcerative colitis.
What could go wrong
This is an early, first-in-human study with a small number of participants, so safety and effectiveness are not yet established. The drug may cause side effects or fail to show benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 64 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Moderate to severe ulcerative colitis are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Moderate to severe ulcerative colitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.