Clinical trial NCT06969664: A Trial of SHR7280 in Healthy Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Endometriosis
Uterine Fibroids
Assisted Reproduction
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-05-14
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Peak concentration (Cmax)
timeFrame: Day 1 to Day 8.
measure: Area under the plasma concentration-time curve from time 0 to the last quantifiable timepoint (AUC0-t)
timeFrame: Day 1 to Day 8.
measure: Area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞)
timeFrame: Day 1 to Day 8.
Secondary outcomes:
measure: Time to peak concentration (Tmax)
timeFrame: Day 1 to Day 8.
measure: Elimination half-life (t1/2)
timeFrame: Day 1 to Day 8.
measure: Adverse events (AEs)
timeFrame: Day 1 to Day 15.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
References: