Endometriosis
Conditions
Interventions
Drug group D002:Seven dose groups (5, 10, 25, 50, 100, 200, 300 mg) with single-dose administration in a fasted state
D002 + ABT drug combination group:Administration in a fasted state of D002 and ABT drugs, estradiol cyproterone tablets (1.0 mg estradiol/2.0 mg cyproterone), both continuously administered for 28 day
Drug group D002:Tentatively 200 mg, administered in both fasted and fed conditions across 2 cycles, with single-dose administration in each cycle
Drug group D002:Three doses (50 mg, 100 mg, 200 mg) administered continuously for 21 days in a fasted state, once daily
Drug group D002:Tentatively 200 mg, single-dose administration in a fasted state.
D002 placebo group:Seven dose groups (5, 10, 25, 50, 100, 200, 300 mg) with single-dose administration in a fasted state
D002 placebo group:Three doses (50 mg, 100 mg, 200 mg) administered continuously for 21 days in a fasted state, once daily
Sponsors
Wuhan Jinyintan Hospital (Wuhan Infectious Disease Hospital)
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1)Voluntarily participate in the clinical trial, sign the informed consent form, be able to communicate well with the researcher, and understand and comply with the requirements and restrictions of this study. 2)Age between 18 and 45 years old, premenopausal women; 3)At the time of screening, body mass index (BMI) ranges from 19.0 to 27.0 kg/m^2 (inclusive), with a weight of = 45 kg; 4)Regular menstrual history, and at least two consecutive regular menstrual cycles (21-35 days [inclusive]) with bleeding lasting for 3 days or more before the screening visit; 5)From the day the informed consent form is signed until 6 months after the last administration of the study drug, the subject has no plans to become pregnant, and during this period, must agree to use at least one highly effective non-hormonal contraceptive measure, or have a male partner who has been sterilized for at least 6 months prior to the screening visit.
Exclusion criteria
Exclusion criteria: 1)Allergic to the active pharmaceutical ingredient or any excipient of the study drug, or contraindicated for its use; 2)A history of significant multiple and/or severe allergies, including food allergies. 3)History of hysterectomy or bilateral oophorectomy; 4)Known or concomitant osteoporosis or other metabolic bone diseases; 5)Previous non-responsiveness to treatment with gonadotropin-releasing hormone (GnRH) agonists or antagonists; 6)Known or concomitant thyroid dysfunction accompanied by menstrual irregularities, or menstrual disorders caused by thyroid dysfunction as assessed by the investigator; 7)Significant metabolic, infectious, cardiovascular, gastrointestinal, hepatic, renal/urological, respiratory, endocrine, hematological, immunological, neurological, reproductive system, thymus, skin, malignant tumor, or psychiatric disease history or current condition requiring medication and/or other treatment, including dietary restriction and physical therapy, which in the investigator’s opinion makes the subject unsuitable for the study; 8)Any condition which might affect drug absorption in the past; 9)History of depression or post-traumatic stress disorder within 2 years prior to the screening visit; suicidal behavior or ideation, or deemed at risk of suicide by the investigator (evaluation by a psychiatrist may be required), which may increase the risk of participation in the study as judged by the investigator; 10)Within 6 months postpartum, or within 3 months postabortion before screening; 11)Past or current cardiovascular risk factors including: a) Torsades de pointes or risk factors for it, including drugs known to prolong cardiac repolarization, hypokalemia, hypomagnesemia, heart failure, bradycardia, cardiomyopathies, long QT syndrome or a history of QTcF > 450 msec; b) Orthostatic hypotension, unexplained syncope, myocardial infarction, angina, pulmonary congestion, prolongation of QT interval or conduction abnormalities, sick sinus syndrome, second- or third-degree atrioventricular block, family or personal history of A-Steinert syndrome or Brugada syndrome 12)Unexplained vaginal and/or uterine bleeding or menstrual irregularities which are still clinically significant at the screening or baseline; 13)Major surgery within 3 months prior to screening or surgery which may significantly affect the safety evaluation; 14)Serious infection (including pelvic inflammatory disease or pelvic infection), injury, or major surgery within 1 month prior to screening, or plans for abdominal surgery during the study; 15)Treatment with a GnRH agonist or antagonist within 6 months prior to screening; 16)The use of oral contraceptives within 3 months prior to screening or long-acting estrogen or progestin injections (including progestin-containing intrauterine devices) or implants within 12 months prior to drug administration (Day 1); 17)Vaccination within 4 weeks before screening or plans to be vaccinated during the study; 18)Use of known CYP3A inducers or inhibitors within 1 month before the screening; 19)Any use of prescription or non-prescription drugs (including herbal remedies, vitamins, minerals, and dietary supplements) within 14 days or at least 5 half-lives before the screening, whichever is longer; 20)May require prohibited medications or treatments during the study (Note: Dietary fiber supplements or other methods of promoting bowel movements such as laxatives allowed in Part-5 are excluded); 21)History of drug abuse within 6 month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events and laboratory abnormalities.;Other safety data, including but not limited to: reasons for withdrawal from the study, concomitant medications, vital signs, electrocardiogram (ECG), and physical examination results.;Postprandial and fasting pharmacokinetic (PK) parameters.;Changes over time in E2,FSH,LH,P;The total recovery rate of CMS-D002-related substances in urine and feces, as well as the combined recovery through both routes, expressed as a percentage (%) of the total administered dose over the sampling period after administration.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic (PK) parameters of CMS-D002.; Pharmacodynamic (PD) characteristics following a single-dose administration in a SAD;Changes in pharmacodynamics (PD) over time relative to baseline following multiple-dose administration in a MAD ;Pharmacodynamic (PD) characteristics of estradiol (E2) following administration on Day 21 in a MAD;Cardiac QT interval-related parameters.;Incidence and severity of adverse events and laboratory abnormalities.;Other safety data, including but not limited to: reasons for withdrawal from the study, concomitant medications, vital signs, electrocardiogram (ECG), and physical examination results.;Correlation analysis between pharmacokinetics (PK) and pharmacodynamics (PD).;Plasma pharmacokinetic (PK) parameters.; | — |
Countries
China
Contacts
Public ContactChaolin Huang
Wuhan Jinyintan Hospital (Wuhan Infectious Disease Hospital)
Outcome results
None listed