A Trial of SHR7280 in Healthy Subjects

Hengrui Medicine

Status and phase: Completed; Phase 1

Conditions: Assisted Reproduction; Uterine Fibroids; Endometriosis

Treatments: Drug: SHR7280 Tablet; Drug: SHR7280 Placebo Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT06969664

SHR7280-107

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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16 participants in 2 patient groups

Treatment group A

Experimental group

Treatment:

Drug: SHR7280 Placebo Tablet

Drug: SHR7280 Tablet

Treatment group B

Experimental group

Treatment:

Drug: SHR7280 Placebo Tablet

Drug: SHR7280 Tablet