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

Sponsor
Zhuhai Huahaikang Pharmaceutical Technology Co., Ltd.
Study ID
NCT07755956
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Leuprorelin Acetate — DRUG
    Participants will receive a single subcutaneous injection of 3.75 mg HHK001 (investigational leuprorelin acetate preparation).
  • Leuprorelin Acetate 3.75mg Injection — DRUG
    Participants will receive a single subcutaneous injection of 3.75 mg Enantone (commercially-available leuprorelin acetate preparation).

Study Details

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.

Key Dates

First listed
Aug 10, 2026
Start date
Aug 31, 2026
Status verified
Aug 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HHK001
  • Active Comparator: Enantone

Primary Outcome Measure

Concentrations of leuprorelin acetate [ Time Frame: Baseline through 70 days post-dose ]

Central Contacts

Find similar trials

Nationwide
Endometriosis trialsWomen's health trialsFertility trials

Related Studies