A Phase Ia Clinical Trial to Compare Pharmacokinetics, Pharmacodynamics, Safety and Preliminary Efficacy of HHK001 Versus Enantone in Patients With Endometriosis
The goal of this clinical trial is to find out how the study drug HHK001 compares to Enantone (an approved treatment for endometriosis) when given as a single 3.75 mg injection to participants with endometriosis. Both products contain the same active ingredient: leuprorelin acetate. We will check how the body absorbs and responds to each medicine, monitor possible side effects and treatment benefits. Researchers will compare HHK001 to Enantone to test the advantages of its updated formulation.
• 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.