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Healthy volunteers needed to test safety of new drug HRS-2183

NCT ID NCT07232758

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 2 times

Summary

This early-stage study tests the safety and tolerability of a new injectable drug called HRS-2183 in 42 healthy Chinese adults aged 18-45. Participants receive either a single dose or multiple doses to see how the drug moves through the body and if it causes any side effects. This study does not aim to treat any disease.

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

12 people

The number who actually took part.

Started

Oct 2025

Finished

Jan 2026

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 45 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: 1. Healthy male and female subjects, aged 18 to 45 years. 2. Body weight and Body Mass Index (BMI) within a specified range (e.g., BMI 19.0-26.0 kg/m²). 3. Agreement to use highly effective contraception during the study period and for a specified duration after the last dose. No plans for pregnancy, sperm/egg donation. 4. Voluntarily provides written informed consent to participate in the study. Exclusion Criteria: 1. History of significant allergies to any food or drug, especially to the investigational product, its components, or drugs of a similar class. 2. History or current presence of any clinically significant disease in major organ systems (e.g., cardiovascular, hepatic, renal, neurological, etc.). 3. Any clinically significant abnormalities found during screening assessments (including physical examination, vital signs, and laboratory tests). 4. Clinically significant abnormalities on 12-lead electrocardiogram (ECG) at screening. 5. Evidence of impaired renal function based on laboratory tests (e.g., eGFR, serum creatinine). 6. Positive screening for specified infectious diseases (e.g., HIV, HBV, HCV, Syphilis). 7. Use of any medication (including prescription, OTC, and herbal) within a specified period before the study. 8. Excessive consumption of certain beverages (e.g., caffeine, grapefruit juice) or inability to adhere to dietary restrictions. 9. History of major surgery within the past 3 months or planned surgery during the study period. 10. Participation in another clinical trial within the past 3 months. 11. Significant blood loss, blood donation, or transfusion within the past 3 months. 12. History of excessive alcohol consumption or unwillingness to abstain during the study. 13. History of heavy smoking or unwillingness to abstain during the study. 14. History of drug abuse or positive drug screening test. 15. Inability to tolerate venous access or history of fainting during blood draws. 16. Inability to comply with the standardized diet provided during the study. 17. Any other reason that, in the opinion of the investigator, makes the subject unsuitable for the study.

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As listed by the trial registrant

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

Contacts and locations

Locations

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250100, China