None
Conditions
Interventions
T-R group:In the first cycle, SJ04 injection (T) is given, and after a 14-day washout period, the second cycle gives Aize? (R).
R-T group:In the first cycle, give Aize? (R), and after a 14-day washout period, give SJ04 injection (T) in the second cycle.
Sponsors
Suzhou Municipal Hospital
Eligibility
Sex/Gender
Female
Age
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1.Healthy female subjects aged 20 to 40 years old (including the boundary value); 2.The subject's weight should be no less than 45.0 kg, and the body mass index [BMI= weight (kg)/height ^2 (m ^2)] should be within the range of 19.0 to 26.0 kg/m^2 (including the boundary value); 3. The subjects had regular menstrual cycles, or had regular menstrual cycles before taking oral contraceptives (25 to 34 days, including the boundary value); 4. The levels of early follicle-stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL), estradiol (E2), progesterone (P), and testosterone (T) detected by the subjects within 2 to 3 days after the most recent menstrual period before the first administration were within the normal range or were considered abnormal by the researchers and had no clinical significance. 5. The subjects' D-1 reached the pituitary down-regulation standard: LH <5 IU/L, FSH <4 IU/L; 6. Those who voluntarily participate and sign the informed consent form; The process of obtaining informed consent forms complies with the requirements of Good Clinical Practice (GCP) for drug clinical trials. 7. Subjects who can communicate well with the researcher and understand and abide by all the requirements of this trial.
Exclusion criteria
Exclusion criteria: 1. Those who are allergic to or suspected of being allergic to any of the test drugs, control drugs, GnRH or GnRH analogues in this study; 2. Those who have used any LH preparations, human menopausal gonadotropin (hMG), or human chorionic gonadotropin (hCG) preparations within the three months prior to screening; 3. Those who have had or are currently suffering from the following diseases: hypothalamic or pituitary tumors; Unexplained ovarian enlargement or cysts; Abnormal uterine bleeding of unknown cause; Malignant tumors of the ovaries, uterus or breast; Active thromboembolic disease; Uncontrollable thyroid or adrenal dysfunction; Endocrine disorders, such as hyperprolactinemia, polycystic ovary syndrome, ovarian hyperstimulation syndrome (OHSS), and ovarian insufficiency, etc. Other malignant tumors or diseases of the hypothalamus, pituitary gland, ovaries and uterus (except uterine fibroids); 4. The subjects had experienced ectopic pregnancy within 3 months prior to the screening. 5. There were acute or chronic infections of clinical significance at the time of screening/enrollment; 6. Those with local diseases that affect the subcutaneous injection site or who cannot tolerate subcutaneous injection; 7. Those who have difficulty in blood collection or cannot tolerate venipuncture, or have a history of fainting at the sight of needles or blood; 8. Those who have taken prescription drugs or over-the-counter drugs (including Chinese patent medicines and herbal medicines) within 14 days or 5 half-lives (if known) (whichever is the longest) before screening (if known); 9. Those with a history of chronic or severe diseases in the liver, kidneys, digestive tract, endocrine system, cardiovascular and cerebrovascular system, nervous system, metabolic system, blood system, respiratory system and autoimmune system, or existing diseases in the above systems, and who are determined by the researcher to be unsuitable for enrollment; 10. Those whose vital signs, physical examination, laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function, thyroid function), 12-lead electrocardiogram (ECG), liquid-based thin-layer cell detection (TCT), and B-ultrasound abnormalities are determined by the researcher to be of clinical significance and affect their participation in this trial; 11. Those who test positive for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, and Treponema pallidum antibody; 12. Those with a history of mental illness, drug abuse, or drug dependence; Or those who test positive for drug abuse screening (morphine, tetrahydrocannabinic acid, methamphetamine, dimethylene dimethoxyamphetamine, ketamine) on the day of check-in; 13. Those who have consumed excessive amounts of tea, coffee or caffeinated beverages (more than 8 cups a day, 1 cup =250 ml) within the three months prior to screening; 14. Those who consumed an average of more than 14 standard units per week (1 standard unit contains 14 g of alcohol, such as 360 ml of beer or 45 ml of 40% alcohol spirits or 150 ml of wine) within the three months prior to screening; Or those who cannot abstain from alcohol during the trial period; Or those with a positive result in an alcohol breath test on the day of check-in; 15. Those who smoked at least 5 cigarettes per day within the 3 months prior to screening; Or those who cannot stop using any tobacco products during the trial period; 16. Those who
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic (PK) evaluation indicators (Cmax; AUC 0-t; AUC 0-8); | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety indicators (adverse events (AEs), serious adverse events (SAEs), lab tests (blood routine, blood biochemistry, urine routine, coagulation function, thyroid function), sex hormone tests [FSH, LH, PRL, E2, P, testosterone (T)], vital signs (temperature, pulse, seated blood pressure), 12-lead ECG, physical examination, ultrasound, injection site reactions, etc.);Immunogenicity evaluation indicators (the positive rate of anti-drug antibodies after administration; the neutralizing ability of antibodies in positive samples); | — |
Countries
China
Contacts
Public ContactYu Yanxia
Suzhou Municipal Hospital
Outcome results
None listed