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COMPLETEDPHASE1

A Trial of SHR7280 in Healthy Subjects

A Phase I Clinical Study to Evaluate Effect of High-Fat Diet on Pharmacokinetics of a Single Oral Dose of SHR7280 Tablets and to Assess the Effect of SHR7280 on QT Interval in Healthy Subjects

NCT06969664•Jiangsu HengRui Medicine Co., Ltd.

View on ClinicalTrials.gov

Summary

The study is being conducted to evaluate the effect of high-fat meal on pharmacokinetics of SHR7280 after oral administration and the effect of SHR7280 on QT interval at low and high doses in healthy Chinese volunteers.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

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.

Locations (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Key Dates

Start Date

May 19, 2025

Primary Completion Date

July 5, 2025

Completion Date

July 5, 2025

Last Updated

August 19, 2025

Enrollment

ACTUAL participants

Conditions

EndometriosisUterine FibroidsAssisted Reproduction

Interventions

SHR7280 Tablet

DRUG

SHR7280 Placebo Tablet

DRUG

The Developmental Origins of Endometriosis

NCT05951452

Endometriosis

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RECRUITINGPHASE2

Glycemic Regulation as Endometriosis Adjunct Treatment

NCT06611501

Pelvic PainEndometriosis

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RECRUITINGPHASE3

The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy (INCyst Trial)

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Trial of SHR7280 in Healthy Subjects

Inclusion Criteria

Exclusion Criteria

The Developmental Origins of Endometriosis

Glycemic Regulation as Endometriosis Adjunct Treatment

The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy (INCyst Trial)

Effect of Tele-Yoga on Pain, Fatigue, and Quality of Life in Endometriosis

Comparison of Proton or Intensity Modulated Radiation Therapy After Surgery for Endometrial or Cervical Cancer

Selective Removal of Endometriotic Lesions Using CUSA Clarity in Ovarian Endometriomas