Phase Ia Trial of HHK001 Compared With Enantone in Patients With Endometriosis

Inclusion criteria

• Voluntarily provide written informed consent;
• Female, aged 18-45 years, weight ≥ 40 kg, body mass index 19-28 kg/m²;
• The most recent menstrual cycle 21-35 days;
• Confirmed diagnosis of endometriosis, and suitable for GnRH agonist;
• Cervical cytology test result showing No Intraepithelial Lesion or Malignancy;
• No plan for pregnancy, egg cryopreservation or donation, and agree to use effective contraception from screening through 3 months after dosing.

Exclusion criteria

• Allergic to GnRH agonists/antagonists, or history of allergies to ≥3 different substances, or active allergic disease;
• With contraindications to rescue medication (ibuprofen);
• Current or past medical history of osteoporosis/osteopenia, pituitary tumor, epilepsy, depressive disorder, thromboembolic events, malignant tumors, unexplained abnormal uterine bleeding;
• Received any GnRH agonist/antagonist within 12 weeks before screening;
• Received medications that may significantly alter hypothalamic-pituitary-gonadal axis hormone levels within 4 weeks before screening;
• History of miscarriage within 4 weeks before screening;
• History of alcohol dependence, drug abuse or illicit substance use;
• Other conditions unsuitable for the trial judged by the investigator.