A Clinical Study Evaluating the Relative Bioavailability of SHR7280 Dry Suspension and Tablets

NCT05868057 | Completed Phase 1

• 1 other identifier: SHR7280-105
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the relative bioavailability of SHR7280 dry suspension and tablets in healthy subjects. To assess the safety and tolerability of a single dose of SHR7280 dry suspension and tablets.

Conditions

Endometriosis, Uterine Fibroids, Male Hormone-sensitive Prostate Cancer, Assisted Reproduction

Outcome Measures

Primary Outcomes (4)

• SHR7280 and its main Pk parameter AUC0-t

  Day 1 to Day 5

• SHR7280 and its main Pk parameter AUC0-∞

  Day 1 to Day 5

• SHR7280 and its main Pk parameter Cmax

  Day 1 to Day 5

• Relative bioavailability (F%) value between SHR7280 dry suspension and SHR7280 tablet: F% = AUC0-t (dry suspension) / AUC0-t (tablet) ×100%

  Day 1 to Day 5

Secondary Outcomes (5)

• SHR7280 and its main Pk parameter Tmax (SHR7280 only)

  Day 1 to Day 5

• SHR7280 and its main Pk parameter t1/2 (SHR7280 only)

  Day 1 to Day 5

• SHR7280 and its main Pk parameter CL/F (SHR7280 only)

  Day 1 to Day 5

• SHR7280 and its main Pk parameter Vz/F (SHR7280 only)

  Day 1 to Day 5

• Adverse events

  Day 1 to Day 10

Study Arms (2)

Treatment group ARM 1

EXPERIMENTAL

SHR7280 dry suspension then SHR7280 tablets

Drug: SHR7280 tablets; Drug: SHR7280 dry suspension

Treatment group ARM 2

EXPERIMENTAL

SHR7280 tablets, then SHR7280 dry suspension

Drug: SHR7280 tablets; Drug: SHR7280 dry suspension

Interventions

SHR7280 tablets DRUG

SHR7280 tablets 1 time

Treatment group ARM 1; Treatment group ARM 2

SHR7280 dry suspension DRUG

SHR7280 dry suspension 1 time

Treatment group ARM 1; Treatment group ARM 2

Eligibility Criteria

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

You may qualify if:

• Voluntarily sign the informed consent form before the start of the activities related to the trial, and be able to understand the procedures and methods of the trial, and be willing to strictly abide by the clinical trial protocol to complete the trial;
• Age 18\~45 years old (including both end values, subject to the signing of informed consent);
• Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 18\~30 kg/m2 (including both end values);
• Those who have no birth plan and no sperm or egg donation plan within 1 week after signing the informed consent form and the last dose, and agree to use highly effective contraceptive measures;
• Women have regular menstruation in the last 3 days before the screening visit, with a menstrual cycle of 24\~35 days and a menstrual period of 3\~7 days.

You may not qualify if:

• Female screening period or baseline period (D-1) urine pregnancy test or serum pregnancy test (serum β-HCG test) results are positive;
• The female had any form of pregnancy (including spontaneous abortion, childbirth, ectopic pregnancy, etc.) within 3 months before randomization, or was breastfeeding at the time of the screening visit;
• Women found ovarian cysts or masses with a diameter of ≥ 4 cm during the screening period;
• Women use the following contraceptive methods during screening visits: drug sustained-release IUD, sustained-release contraceptives (subcutaneous implants, vaginal rings, microspheres and microcapsule contraceptive injections); Use of long-acting contraceptive injections before screening (contraindicated 3 months before screening for medroxyprogesterone acetate and 1 month before screening for other injections), oral contraceptives 2 months before screening, and contraceptives 1 month before screening; Special circumstances are judged by the investigator;
• Those with a history of tobacco addiction in the previous 3 months (an average daily smoking \> 5);
• Average daily alcohol intake of more than 25 g (e.g., 750 mL of beer, 250 mL of wine, or 50 mL of liquor) in the 3 months prior to randomization;
• Consumed any drink or food containing grapefruit within 7 days prior to randomization; or eat any beverage or food containing methylxanthines, such as coffee, tea, cola, chocolate, etc., within 2 days before randomization;
• Allergic constitution, or suspected allergy to any ingredient in SHR7280 preparation;
• Drug abusers, or positive urine drug abuse screening at screening, including: morphine, meth (methamphetamine), ketamine, cocaine, ecstasy (methylenedioxyamphetamine), marijuana (tetrahydrocannabinolic acid);
• Have a history of any clinically serious disease or disease or condition that the investigator believes may affect the test results, including but not limited to a history of circulatory, endocrine, nervous system, digestive system, urinary system or blood, immune, psychiatric and metabolic diseases;
• QTcF \> 450 ms at screening or baseline 12-lead ECG (maximum retest 2 times allowed, average value can be taken), or there are other abnormalities judged by the investigator to be clinically significant;
• Vital signs, physical examination, laboratory tests, abdominal ultrasound or chest imaging at screening, etc., suggest that there are abnormalities that are judged to be clinically significant by the investigator;
• Within 4 weeks before randomization, positive hepatitis B surface antigen (HBsAg), or positive anti-hepatitis C virus (HCV) antibody, or positive human immunodeficiency virus (HIV) antibody, or positive syphilis antibody;
• Use of any prescription drug, over-the-counter drug, Chinese herbal medicine or dietary supplement within 2 weeks prior to randomization;
• Those who have participated in clinical trials of any other drug or medical device within 3 months before randomization or within 5 half-lives of the drug (subject to whether to administer or use the device);

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 511447, China

Location

Related Publications (1)

• Liu X, Qin R, Shu C, Shen K, Li X, Ma L, Li X, Li L, Peng J, Huang D, Chen S, Xie Z, Ye L, Duan L. Relative Bioavailability of Single-Dose Oral Administration of Two SHR7280 Formulations (Dry Suspension and Tablets) in Healthy Chinese Volunteers. Clin Drug Investig. 2025 Sep;45(9):643-650. doi: 10.1007/s40261-025-01470-7. Epub 2025 Aug 8.

  PMID: 40779283 DERIVED

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: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: May 22, 2023
• Study Start: May 23, 2023
• Primary Completion: June 9, 2023
• Study Completion: October 20, 2023
• Last Updated: December 8, 2023

Record last verified: 2023-12

Locations

CN (1)