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

NCT07793162 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-08-28

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Zhuhai Huahaikang Pharmaceutical Technology Co., Ltd.

    collaborator INDUSTRY

  • The Third Xiangya Hospital of Central South University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2027-12-31
Completion
2027-12-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07793162 on ClinicalTrials.gov