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

NCT07755956 | Not Yet Recruiting Phase 1

• 1 other identifier: HHK001-1a
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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

Endometriosis

Keywords

leuprorelin; pharmacokinetics; pharmacodynamics; endometriosis

Outcome Measures

Primary Outcomes (2)

• Concentrations of leuprorelin acetate

  Concentrations assessed by pre-specified methods

  Baseline through 70 days post-dose

• Concentrations of estradiol

  Concentrations assessed by pre-specified methods

  Baseline through 70 days post-dose

Secondary Outcomes (2)

• Number of participants with Adverse events

  Baseline through 70 days post-dose

• Changes from baseline in overall pain score

  Baseline through 70 days post-dose

Study Arms (2)

HHK001

EXPERIMENTAL

Drug: Leuprorelin Acetate

Enantone

ACTIVE COMPARATOR

Drug: Leuprorelin Acetate 3.75mg Injection

Interventions

Leuprorelin Acetate DRUG

Participants will receive a single subcutaneous injection of 3.75 mg HHK001 (investigational leuprorelin acetate preparation).

HHK001

Leuprorelin Acetate 3.75mg Injection DRUG

Participants will receive a single subcutaneous injection of 3.75 mg Enantone (commercially-available leuprorelin acetate preparation).

Enantone

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhuhai Huahaikang Pharmaceutical Technology Co., Ltd.: lead

MeSH Terms

Conditions

Endometriosis

Interventions

Leuprolide; Injections

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Feng

  Zhuhai Huahaikang Pharmaceutical Technology Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Liang Li

CONTACT

+86 15800440760; liliang@hhkmed.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 10, 2026
• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share