A Trial of SHR7280 in Healthy Subjects

Launched by JIANGSU HENGRUI MEDICINE CO., LTD. · May 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a drug called SHR7280 to understand how it behaves in the body, especially after eating a high-fat meal. Researchers want to see how the drug affects heart rhythm at different doses in healthy volunteers. The trial is not yet recruiting participants, but when it does, it will be looking for healthy individuals aged between 18 and 45. To participate, you need to weigh at least 50 kg for men and 45 kg for women, and have a body mass index (BMI) that falls between 18 and 26. Importantly, participants should not be planning for pregnancy or sperm/egg donation during the study.

If you join the trial, you'll first sign a consent form to show you understand the study and agree to follow its rules. The study will require you to stick to certain dietary guidelines, including eating high-fat meals, and you’ll be monitored closely for your health throughout the process. However, there are some health conditions and lifestyle factors, like recent surgeries, serious illnesses, or tobacco use, that may prevent you from participating. Overall, this study aims to gather important information that could help in treating conditions like endometriosis and uterine fibroids in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Voluntarily sign the informed consent form prior to any activities in the trail, demonstrate comprehension of the trial procedures and methodology, and agree to strictly adhere to the protocol throughout the study period.
• • 2. Be aged between 18 and 45 years inclusive (determined at the time of signing the informed consent form).
• • 3. Have a body weight of ≥50 kg for males and ≥45 kg for females, with a Body Mass Index (BMI) between 18 and 26 kg/m² inclusive.
• • 4. Have no plans for pregnancy or sperm/egg donation from the time of signing the inform consent form until 1 week after the last administration of the investigational product, and agree to use highly effective contraceptive measures.
• Exclusion Criteria:
• • 1. Individuals with a history of chronic or serious diseases, or current conditions affecting the respiratory, circulatory, digestive, urinary, hematological, endocrine, immune, nervous, or psychiatric systems, and deemed ineligible to participate in this trial by the investigator.
• • 2. Females who are pregnant, breastfeeding, or with a positive serum pregnancy test during the screening or baseline period.
• • 3. History of smoking (average daily cigarette consumption \>5 cigarettes) within 3 months prior to randomization, or any use of tobacco products during the study period.
• • 4. History of drug abuse, positive urine drug abuse screen at the screening period.
• • 5. Receipt of live (attenuated) vaccines within 1 month prior to screening or planned administration during the trial (excluding influenza vaccines).
• • 6. Undergoing any surgical procedure within 3 months prior to randomization, incomplete recovery from surgery, or anticipated need for surgery or hospitalization during the trial period.
• • 7. Inability to comply with standardized dietary requirements, intolerance to high-fat meals, or presence of dysphagia.
• • 8. Any condition judged by the investigator to potentially affect drug absorption, distribution, metabolism, or excretion, reduce compliance, or pose other risks that make participation in the study inappropriate.