The Pharmacokinetic(PK)/Pharmacodynamics(PD) Study of SHR7280 Tablets in Premenopausal Subjects With Endometriosis.

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

The primary objective of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR7280 tablets in premenopausal subjects with endometriosis. In addition, this study will provide information on efficacy of SHR7280 tablets in premenopausal subjects with endometriosis.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Criteria

Inclusion Criteria:

Phase I/II

1. premenopausal females, aged 18-45

2. History of regular menstrual cycles

3. Participant has a documented surgical diagnosis (e.g., laparoscopy or laparotomy) of endometriosis established by visualization within 10 years prior to entry into Washout or Screening.

4. Participant must agree to use only protocol specified rescue analgesics during the Screening and Treatment Periods for endometriosis-associated pain

5. Participant in general good health. No clinically significant findings in laboratory parameters or clinically significant abnormality on X-ray

Phase I (only) Participant has mild or moderate pelvic pain associated with endometriosis, VAS≤60mm at Screening

Phase II(only)

1. Participant has moderate or severe pelvic pain associated with endometriosis，VAS>30mm at Screening and Baseline

2. Participant must have the following documented in the e-Diary: at least 2 days of "moderate" or "severe" Dysmenorrhea (DYS≥2) during baseline and DYS≥2 on D-1 prior to randomization

Exclusion Criteria:

Phase I/II

1. Subjects with severe trauma or surgery within 6 months prior to the screening；

2. Known blood donation within 30 days pre-dose; donating≥200 ml of blood 2 months pre-dose;

3. Pregnant or Serum β-human chorionic gonadotropin (hCG)> 5 MillionInternationalUnits(mIU)/mL at screening or baseline

4. Pregnant or breast feeding ;

5. Planning a pregnancy within the next 12 months

6. Have pelvic pain that is not caused by endometriosis

7. Abnormal uterine bleeding

8. Are currently receiving gonadotropin-releasing hormone (GnRH) agonist, a GnRH antagonist or danazol or have received any of these agents within 6 months of the start of screening.

9. Are currently receiving subcutaneous medroxyprogesterone acetate (DMPA-SC) or intramuscular medroxyprogesterone acetate (DMPA-IM) or have received any of these agents within 3 months of the start of screening.

10. Are currently using hormonal contraception or other forms of hormonal therapy or received such treatment within the last month.

Phase I (only) one month prior to screening involved in any drug or medical device clinical subjects, or within 5 half-life of drugs before screening;

Phase II (only) Participant have bone mineral density(BMD) with either lumbar spine （L2-L4）T-scores below -2.5 at screening as determined by the central dual energy x-ray absorptiometry( DXA) facility，diagnosed osteoporosis