A Phase 1 Clinical Study to Evaluate the Effects of SHR7280 on the Pharmacokinetics of Midazolam, S-warfarin, Omeprazole, Digoxin, and Rosuvastatin in Healthy Subjects

Launched by JIANGSU HENGRUI MEDICINE CO., LTD. · Apr 22, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new medication called SHR7280 and how it affects the way the body processes several common drugs, including midazolam, S-warfarin, omeprazole, digoxin, and rosuvastatin. The main goal is to understand how SHR7280 interacts with these medications in healthy male volunteers. This study is important because it will help researchers learn more about the safety and effectiveness of SHR7280, which may be relevant for conditions like endometriosis and uterine fibroids.

To be eligible for this study, participants must be healthy males aged 18 to 45 years old, weigh at least 50 kg, and have a normal body mass index (BMI) between 19 and 26. They should also be willing to follow the study procedures and use effective contraception during the trial. Participants will undergo several health checks before the study begins to ensure they are suitable. If you or someone you know fits these criteria and is interested, this could be an opportunity to contribute to important medical research while receiving careful monitoring by healthcare professionals.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Voluntarily sign the informed consent form prior to any study-related activities, understand the procedures and methods of the study, and agree to complete this study in strict accordance with the clinical study protocol.
• • 2. Males aged 18-45 years (inclusive).
• • 3. Subjects who are generally healthy as judged by the investigator based on medical history, vital signs, physical examination, laboratory tests, and electrocardiogram (ECG).
• • 4. Weight ≥ 50 kg and body mass index (BMI) : 19-26 kg/m2 (inclusive).
• • 5. Informed consent was obtained and patients did not plan to have children within 3 months after the last dose of medication, and they agreed to use highly effective contraception.
• Exclusion Criteria:
• • 1. Those with clinically significant abnormalities in physical examination, vital signs (respiration, temperature, pulse), other laboratory tests, chest imaging, abdominal ultrasound, etc.
• • 2. Hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody and syphilis antibody positive.
• • 3. Patients with any previous diseases that increase the risk of bleeding.
• • 4. Patients with previous chronic or severe medical history or existing diseases of the respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, and mental system, who were judged by the investigators to be not suitable for the trial.
• • 5. History of blood donation or blood loss ≥ 400 mL or blood transfusion within 3 month before screening.
• • 6. Subjects with other factors considered by the investigator to be ineligible for the study.