A Trial of SHR7280 in Healthy Subjects

NCT06969664 | Completed Phase 1

• 1 other identifier: SHR7280-107
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis; Uterine Fibroids; Assisted Reproduction

Outcome Measures

Primary Outcomes (3)

• Peak concentration (Cmax)

  Day 1 to Day 8.

• Area under the plasma concentration-time curve from time 0 to the last quantifiable timepoint (AUC0-t)

  Day 1 to Day 8.

• Area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞)

  Day 1 to Day 8.

Secondary Outcomes (3)

• Time to peak concentration (Tmax)

  Day 1 to Day 8.

• Elimination half-life (t1/2)

  Day 1 to Day 8.

• Adverse events (AEs)

  Day 1 to Day 15.

Study Arms (2)

Treatment group A

EXPERIMENTAL

Drug: SHR7280 Tablet; Drug: SHR7280 Placebo Tablet

Treatment group B

EXPERIMENTAL

Drug: SHR7280 Tablet; Drug: SHR7280 Placebo Tablet

Interventions

SHR7280 Tablet DRUG

Oral SHR7280 tablet.

Treatment group A; Treatment group B

SHR7280 Placebo Tablet DRUG

Oral SHR7280 placebo tablet.

Treatment group A; Treatment group B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Be aged between 18 and 45 years inclusive (determined at the time of signing the informed consent form).
• 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.
• 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.

You may not qualify if:

• 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.
• Females who are pregnant, breastfeeding, or with a positive serum pregnancy test during the screening or baseline period.
• 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.
• History of drug abuse, positive urine drug abuse screen at the screening period.
• Receipt of live (attenuated) vaccines within 1 month prior to screening or planned administration during the trial (excluding influenza vaccines).
• 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.
• Inability to comply with standardized dietary requirements, intolerance to high-fat meals, or presence of dysphagia.
• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510300, China

Location

MeSH Terms

Conditions

Endometriosis; Leiomyoma

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 14, 2025
• Study Start: May 19, 2025
• Primary Completion: July 5, 2025
• Study Completion: July 5, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

CN (1)