Healthy volunteers needed to test safety of new drug HRS-2183
NCT ID NCT07232758
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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12 people
The number who actually took part.
- Started
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Oct 2025
- Finished
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Jan 2026
- Lead sponsor
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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
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18 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Qilu Hospital of Shandong University
Jinan, Shandong, 250100, China