Prostate cancer requiring androgen depot therapy, endometriosis
Conditions
Interventions
Part A 5mg group:Randomised in a 4:1 ratio to use trial drug and placebo
Part A 10mg group:Randomised in a 4:1 ratio to use trial drug and placebo
Part A 20mg group:Randomised in a 4:1 ratio to use trial drug and placebo
Part A 40mg group:Randomised in a 4:1 ratio to use trial drug and placebo
Part A 80mg group:Randomised in a 4:1 ratio to use trial drug and placebo
Part A Positive control drug group:Oral control Relugolix 40 mg
Part B 40mg group:Randomised in a 4:1 ratio to use trial drug and placebo
Part B 80mg group:Randomised in a 4:1 ratio to use trial drug and placebo
Part B 120mg group:Randomised in a 4:1 ratio to use trial drug and placebo
Part B 240mg group :Randomised in a 4:1 ratio to use trial drug and placebo
Part B 360mg group:Randomised in a 4:1 ratio to use trial drug and placebo
Part B Positive control drug group:Oral control Relugolix 40 mg
Sponsors
Clinical Trial Center of Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. subjects voluntarily signing a written informed consent form; 2. healthy male or female subjects aged 18-45 years (including borderline values), with female subjects being non-menopausal women; 3. male body weight = 50 kg, female body weight = 45 kg, and body mass index (BMI) 19.0 kg/m2 = BMI = 26.0 kg/m2; 4. have a regular menstrual cycle (28±7 days) within 3 months prior to screening (this applies to female subjects); 5. female subjects must have used effective contraception (hormonal contraceptives are prohibited) for at least 2 weeks prior to screening and have a negative blood pregnancy test result during the screening period; subjects or their heterosexual partners agree to use effective contraception (hormonal contraceptives are prohibited) for 3 months after the test medication is administered, or either partner is sterilised.
Exclusion criteria
Exclusion criteria: 1. those who have previously suffered from any clinically serious diseases such as haematological, circulatory, digestive, urinary, respiratory, neurological, immune, endocrine, malignant neoplasm, psychiatric and metabolic abnormalities, or any other diseases or physiological conditions that can interfere with the results of the test; 2. screening visit vital signs, physical examination, laboratory tests and ancillary investigations that reveal abnormalities that, in the judgement of the investigator, would interfere with the study or pose an obvious risk to the subject; 3. the most recent delivery and miscarriage is 450ms (males) or >470ms (females) at screening; 11. application of a GnRH agonist within 6 months prior to screening or use of a GnRH antagonist or any sex hormone analogue within 2 months prior to screening; 12. blood donation or significant blood loss (=200 mL, excluding blood loss during menstruation in women) within 1 month prior to Screening, those who have received a blood transfusion or used blood products, or those who have undergone a major surgical procedure or plan to undergo a surgical procedure during the study; 13. live or live attenuated vaccines administered within 1 month prior to screening or scheduled to be administered during the study or within 1 month after the study; 14. participation in a clinical trial and use of any clinical trial medication within 3 months prior to dosing; or use of any prescription medication within 28 days prior to dosing; or use of any over-the-counter medication, including nutraceuticals, within 7 days prior to dosing 15. ingestion of caffeine and/or purine-rich foods or beverages (e.g., coffee, tea, chocolate and caffeinated carbonated beverages, colas, etc.), tobacco-containing products (e.g., cigarettes, etc.), grapefruit and or grapefruit juice, alcohol or alcoholic products within 48 hours prior to administration; 16. women who are pregnant or breastfeeding; 17. history of tobacco and alcohol abuse within 3 months prior to screening: tobacco use (more than 5 cigarettes or equivalent amount of tobacco per day); alcohol abuse (drinking more than 14 units of alcohol per week: 1 unit = 360 mL of beer or 45 mL of 40% alcohol by volume spirits or 150 mL of wine) or inability to stop the use of any alcohol-containing product or any tobacco product during the te
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| vital signs;Physical examination;laboratory test;Twelve-lead electrocardiogram;Adverse events;Tmax;Cmax;t1/2;CL/F;AUC0-8;AUC0-t;Vd/F;ke;MRT;plasma FSH;plasma LH;plasma E2;Testosterone concentration; | — |
Countries
China
Contacts
Public ContactGuoping Yang/Chengxian Guo
Xiangya Hospital of Central South University
Outcome results
None listed