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NOT YET RECRUITING
NCT07793162
PHASE1

A Phase Ia Trial Comparing the Pharmacokinetics/Pharmacodynamics, Safety, and Preliminary Efficacy of HHK001 and Enantone in Patients With Endometriosis

Sponsor: The Third Xiangya Hospital of Central South University

View on ClinicalTrials.gov

Summary

This study compares the pharmacokinetics/pharmacodynamics (PK/PD), safety, and preliminary efficacy of a single 3.75 mg dose of HHK001 (Leuprorelin Acetate Microspheres for Injection, an improved formulation) versus Enantone (Leuprorelin Acetate Microspheres for Injection) in patients with endometriosis. Approximately 20 patients will be enrolled and randomized in a 1:1 ratio to receive a single subcutaneous injection of HHK001 or Enantone. The post-dose blood sampling/follow-up period is 6 weeks for the Enantone group and 10 weeks for the HHK001 group.

Official title: A Single-Center, Randomized, Open-Label, Phase Ia Trial Comparing the Pharmacokinetics/Pharmacodynamics, Safety, and Preliminary Efficacy of HHK001 and Enantone (Leuprorelin Acetate Microspheres for Injection) in Patients With Endometriosis

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-08-31

Completion Date

2027-12-31

Last Updated

2026-08-28

Healthy Volunteers

No

Conditions

Interventions

DRUG

HHK001 (Leuprorelin Acetate Microspheres for Injection)

HHK001 is an improved formulation of Enantone; both are leuprorelin acetate microspheres for injection, a gonadotropin-releasing hormone (GnRH) agonist. A single dose of 3.75 mg is administered by subcutaneous injection at the lower edge of the deltoid muscle of the upper arm.

DRUG

Enantone (Leuprorelin Acetate Microspheres for Injection)

Enantone is leuprorelin acetate microspheres for injection, a gonadotropin-releasing hormone (GnRH) agonist, used as the active comparator. A single dose of 3.75 mg is administered by subcutaneous injection at the lower edge of the deltoid muscle of the upper arm.