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NOT YET RECRUITING
NCT07755956
PHASE1

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

Sponsor: Zhuhai Huahaikang Pharmaceutical Technology Co., Ltd.

View on ClinicalTrials.gov

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

30

Start Date

2026-08-31

Completion Date

2027-03-31

Last Updated

2026-08-10

Healthy Volunteers

No

Conditions

Interventions

DRUG

Leuprorelin Acetate

Participants will receive a single subcutaneous injection of 3.75 mg HHK001 (investigational leuprorelin acetate preparation).

DRUG

Leuprorelin Acetate 3.75mg Injection

Participants will receive a single subcutaneous injection of 3.75 mg Enantone (commercially-available leuprorelin acetate preparation).