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Phase Ia Trial of HHK001 Compared With Enantone in Patients With Endometriosis
Sponsor: Zhuhai Huahaikang Pharmaceutical Technology Co., Ltd.
Summary
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.
Official title: A Phase Ia Clinical Trial to Compare Pharmacokinetics, Pharmacodynamics, Safety and Preliminary Efficacy of HHK001 Versus Enantone in Patients With Endometriosis
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-10-31
Completion Date
2027-03-31
Last Updated
2026-11-02
Healthy Volunteers
No
Conditions
Interventions
HHK001
Participants will receive a single subcutaneous injection of 3.75 mg HHK001 (investigational leuprorelin acetate preparation).
Enantone
Participants will receive a single subcutaneous injection of 3.75 mg Enantone (commercially-available leuprorelin acetate preparation).
Locations (2)
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Suzhou Municipal Hospital (The Affiliated Suzhou Hospital of Nanjing Medical University)
Suzhou, Jiangsu, China