AzTrials
AzTrials

Endometriosis, Uterine Fibroids, Male Hormone-sensitive Prostate Cancer, Assisted ReproductionPhase 1NCT05868057

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

A Phase 1 study testing SHR7280 tablets and SHR7280 dry suspension in people with Endometriosis, Uterine Fibroids, Male Hormone-sensitive Prostate Cancer, Assisted Reproduction, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
What is being tested?
SHR7280 tablets and SHR7280 dry suspension
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteChina
Study dates
23 May 2023to 20 Oct 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 19Show fewer
  • 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);
  • Have received BCG vaccine within 12 months prior to screening; or vaccination or exposure to other live vaccines or live attenuated vaccines (except COVID vaccines) within 3 months prior to randomization; or those who plan to be vaccinated during the trial;
  • Those who have undergone any surgery within the 3 months prior to randomization, or who have not recovered after surgery, or who may have surgery or hospitalization plans during the estimated trial period;
  • Those who donate blood (or blood loss) within 3 months of randomization and donate blood (or blood loss) in an amount ≥ 400 mL, or receive blood transfusion;
  • The subject is judged by the investigator to have circumstances that affect the absorption, distribution, metabolism and excretion of the drug or can reduce compliance or other factors that are not suitable to participate in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 511447

Other trials in China

About this study

Official title: Clinical Studies Evaluating the Relative Bioavailability of SHR7280 Dry Suspension and Tablets (Single-center, Randomized, Open-label, Crossover)

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.

Being tested
SHR7280 tablets, SHR7280 dry suspension
Medical subject headings
Endometriosis, Leiomyoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR7280 tabletsDrug

    SHR7280 tablets 1 time

  • SHR7280 dry suspensionDrug

    SHR7280 dry suspension 1 time

Study groups in NCT05868057
Study groupRoleWhat they receive
Treatment group ARM 1ExperimentalSHR7280 dry suspension then SHR7280 tablets
Receives: Drug: SHR7280 tablets; Drug: SHR7280 dry suspension
Treatment group ARM 2ExperimentalSHR7280 tablets, then SHR7280 dry suspension
Receives: Drug: SHR7280 tablets; Drug: SHR7280 dry suspension

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SHR7280 and its main Pk parameter AUC0-t

    Measured: Day 1 to Day 5

  2. SHR7280 and its main Pk parameter AUC0-∞

    Measured: Day 1 to Day 5

  3. SHR7280 and its main Pk parameter Cmax

    Measured: Day 1 to Day 5

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

    Measured: Day 1 to Day 5

Secondary outcomes (5)

  1. SHR7280 and its main Pk parameter Tmax (SHR7280 only)

    Measured: Day 1 to Day 5

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

    Measured: Day 1 to Day 5

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

    Measured: Day 1 to Day 5

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

    Measured: Day 1 to Day 5

  5. Adverse events

    Measured: Day 1 to Day 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2023
  2. Study start23 May 2023
  3. Primary completion9 Jun 2023
  4. Study completion20 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05868057
Sponsor's protocol ID
SHR7280-105
Status last verified
Dec 2023
First submitted
11 May 2023
Last updated
8 Dec 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 40779283

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SHR7280 tablets and SHR7280 dry suspension in people with Endometriosis, Uterine Fibroids, Male Hormone-sensitive Prostate Cancer, Assisted Reproduction, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SHR7280 and its main Pk parameter AUC0-t (time frame: Day 1 to Day 5). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05868057, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023; AzTrials last refreshed its copy on 26 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in