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

NCT07755956 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-08-10

No results posted yet for this study

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.

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).

Sponsors & Collaborators

  • Zhuhai Huahaikang Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Feng · Zhuhai Huahaikang Pharmaceutical Technology Co., Ltd.

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
2027-03-31
Completion
2027-03-31

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Entities

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 NCT07755956 on ClinicalTrials.gov