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

Korábbi kezelés

• Subjects with severe trauma or surgery within 6 months prior to the screening；
• 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.
• 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.
• Are currently using hormonal contraception or other forms of hormonal therapy or received such treatment within 2 months of the start of screening.
  • 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) Screening dual-energy x-ray absorptiometry (DXA) scan results of the lumbar spine, femoral neck, or total hip bone mineral density corresponding to 1.5 or more standard deviations below normal (T-score at or below -1.5)

Más betegség

• Abnormal uterine bleeding

Laborértékek

• Pregnant or Serum β-human chorionic gonadotropin (hCG)\> 5 Million International Units(mIU)/mL at screening or baseline

Egyéb

• Phase I/II
• Known blood donation within 30 days pre-dose; donating≥200 ml of blood 2 months pre-dose;
• Pregnant or breast feeding ;
• Have pelvic pain that is not caused by endometriosis

• Phase I/II
• premenopausal females, aged 18-45
• History of regular menstrual cycles
• Endometriosis participant diagnosed by surgical (e.g., laparoscopy or laparotomy) or by magnetic resonance imaging or ultrasonography.
• Participant must agree to use only protocol specified rescue analgesics during the Screening and Treatment Periods for endometriosis-associated pain.
• 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 at Screening.
  • Phase II(only) Participant has moderate or severe pelvic pain associated with endometriosis at Screening.