A Phase Ia Clinical Trial to Compare Pharmacokinetics, Pharmacodynamics, Safety and Preliminary Efficacy of HHK001 Versus Enantone in Patients With Endometriosis
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Concentrations of leuprorelin acetate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
HHK001
干预措施: Leuprorelin Acetate (Drug)
Enantone
干预措施: Leuprorelin Acetate 3.75mg Injection (Drug)
结局指标
主要结局
Concentrations of leuprorelin acetate
时间窗: Baseline through 70 days post-dose
Concentrations assessed by pre-specified methods
Concentrations of estradiol
时间窗: Baseline through 70 days post-dose
Concentrations assessed by pre-specified methods
次要结局
- Number of participants with Adverse events(Baseline through 70 days post-dose)
- Changes from baseline in overall pain score(Baseline through 70 days post-dose)