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

NCT07755956 — Phase 1, Recruiting, 30 participants, Zhuhai Huahaikang Pharmaceutical Technology Co., Ltd.

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A Phase Ia Clinical Trial to Compare Pharmacokinetics, Pharmacodynamics, Safety and Preliminary Efficacy of HHK001 Versus Enantone in Patients With Endometriosis

Registry	NCT07755956
Status	Recruiting
Phase	Phase 1
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	30 (Estimated)
Sponsor	Zhuhai Huahaikang Pharmaceutical Technology Co., Ltd. (Industry)
Conditions	Endometriosis
Interventions	Leuprorelin Acetate, Leuprorelin Acetate 3.75mg Injection (Drug)
Dates	start 2026-08-31 (estimated), primary completion 2027-03-31 (estimated), completion 2027-03-31 (estimated), first posted 2026-08-10, last updated 2026-09-02
Locations	1 site in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
HHK001	Experimental	Drug: Leuprorelin Acetate
Enantone	Active comparator	Drug: Leuprorelin Acetate 3.75mg Injection

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).

+Outcome measures

Primary outcomes

Concentrations of leuprorelin acetate [Baseline through 70 days post-dose]: Concentrations assessed by pre-specified methods
Concentrations of estradiol [Baseline through 70 days post-dose]: Concentrations assessed by pre-specified methods

Secondary outcomes

Number of participants with Adverse events [Baseline through 70 days post-dose]: Adverse events
Changes from baseline in overall pain score [Baseline through 70 days post-dose]: Pain scores measured on a 0-100 visual analog scale, with higher scores indicating greater pain severity

+Eligibility

Sex: Female, ages: 18 Years to 45 Years

Inclusion Criteria:

* Voluntarily provide written informed consent;
* Female, aged 18-45 years, weight ≥ 40 kg, body mass index 19-28 kg/m²;
* The most recent menstrual cycle 21-35 days;
* Confirmed diagnosis of endometriosis, and suitable for GnRH agonist;
* Cervical cytology test result showing No Intraepithelial Lesion or Malignancy;
* No plan for pregnancy, egg cryopreservation or donation, and agree to use effective contraception from screening through 3 months after dosing.

Exclusion Criteria:

* Allergic to GnRH agonists/antagonists, or history of allergies to ≥3 different substances, or active allergic disease;
* With contraindications to rescue medication (ibuprofen);
* Current or past medical history of osteoporosis/osteopenia, pituitary tumor, epilepsy, depressive disorder, thromboembolic events, malignant tumors, unexplained abnormal uterine bleeding;
* Received any GnRH agonist/antagonist within 12 weeks before screening;
* Received medications that may significantly alter hypothalamic-pituitary-gonadal axis hormone levels within 4 weeks before screening;
* History of miscarriage within 4 weeks before screening;
* History of alcohol dependence, drug abuse or illicit substance use;
* Other conditions unsuitable for the trial judged by the investigator.

+Locations (1)

Facility	City	Country	Status
The Third Xiangya Hospital of Central South University	Changsha, Hunan	China	Recruiting

+Investigators

Feng, Study director, Zhuhai Huahaikang Pharmaceutical Technology Co., Ltd.