EndometriosisPhase 1NCT06969664
A Trial of SHR7280 in Healthy Subjects
A Phase 1 study testing SHR7280 Tablet in people with Endometriosis and Uterine Fibroids, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Endometriosis, Uterine Fibroids, Assisted Reproduction
- What is being tested?
- SHR7280 Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 19 May 2025to 5 Jul 2025
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510300
About this study
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
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
- Being tested
- SHR7280 Tablet, SHR7280 Placebo Tablet
- 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 TabletDrug
Oral SHR7280 tablet.
SHR7280 Placebo TabletDrug
Oral SHR7280 placebo tablet.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | Not described Receives: Drug: SHR7280 Tablet; Drug: SHR7280 Placebo Tablet |
| Treatment group B | Experimental | Not described Receives: Drug: SHR7280 Tablet; Drug: SHR7280 Placebo Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak concentration (Cmax)
Measured: Day 1 to Day 8.
Area under the plasma concentration-time curve from time 0 to the last quantifiable timepoint (AUC0-t)
Measured: Day 1 to Day 8.
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞)
Measured: Day 1 to Day 8.
Secondary outcomes (3)
Time to peak concentration (Tmax)
Measured: Day 1 to Day 8.
Elimination half-life (t1/2)
Measured: Day 1 to Day 8.
Adverse events (AEs)
Measured: Day 1 to Day 15.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start19 May 2025
- Primary completion5 Jul 2025
- Study completion5 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06969664
- Sponsor's protocol ID
- SHR7280-107
- Status last verified
- Aug 2025
- First submitted
- 6 May 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06969664
- Acronym / sponsor ID
- SHR7280-107
- Conditions
- Endometriosis, Uterine Fibroids, Assisted Reproduction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 May 2025 (actual)
- Primary completion
- 5 Jul 2025 (actual)
- Study completion
- 5 Jul 2025 (actual)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: SHR7280 Tablet, Drug: SHR7280 Placebo Tablet |
| Treatment group B | Experimental | Drug: SHR7280 Tablet, Drug: SHR7280 Placebo Tablet |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR7280 TabletOral SHR7280 tablet. | Drug | Treatment group A, Treatment group B |
| SHR7280 Placebo TabletOral SHR7280 placebo tablet. | Drug | Treatment group A, Treatment group B |
Primary outcome
Peak concentration (Cmax)
Time frame: Day 1 to Day 8.
Area under the plasma concentration-time curve from time 0 to the last quantifiable timepoint (AUC0-t)
Time frame: Day 1 to Day 8.
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞)
Time frame: Day 1 to Day 8.
3 secondary outcomes
Time to peak concentration (Tmax)
Time frame: Day 1 to Day 8.
Elimination half-life (t1/2)
Time frame: Day 1 to Day 8.
Adverse events (AEs)
Time frame: Day 1 to Day 15.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR7280 Tablet in people with Endometriosis and Uterine Fibroids, 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 4 inclusion and 8 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 19 Aug 2025. 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?
Peak concentration (Cmax) (time frame: Day 1 to Day 8.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2025.