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

ConditionEndometriosis

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexFemale

Age18-45

SponsorThe Third Xiangya Hospital of Central South University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily sign the informed consent form;

Female, aged 18-45 years, body weight >= 40 kg, body mass index 19-28 kg/m2;

The most recent menstrual cycle before screening is 21-35 days;

Diagnosed with endometriosis (previously diagnosed by histopathology, or confirmed by ultrasound or magnetic resonance imaging during screening); participants with concomitant adenomyosis or uterine fibroids are eligible; and assessed by the investigator as suitable for GnRH agonist therapy (no other therapeutic interventions allowed from the start of screening [except rescue medication]);

Disqualifiers

Allergy to GnRH agonists/antagonists (e.g., leuprorelin, triptorelin, goserelin, cetrorelix, ganirelix, degarelix), or a history of allergy to >= 3 substances, or currently in an allergic state;

Contraindications to the rescue medication (ibuprofen) (e.g., allergy to non-steroidal anti-inflammatory drugs, active peptic ulcer, or other conditions assessed by the investigator as contraindications);

Current or previous osteoporosis/osteopenia, pituitary tumor, epilepsy, depressive disorder, thromboembolic events (e.g., myocardial infarction, cerebral infarction, deep vein thrombosis, pulmonary embolism), malignant tumors, abnormal uterine bleeding of unknown nature, or other conditions assessed by the investigator as unsuitable for this trial (e.g., diseases with acute/chronic pain, coagulation disorders, mental disorders, and various severe or unstable diseases);

Receipt of GnRH agonists/antagonists (including investigational products in clinical trials) within 12 weeks before screening or during screening;

Trial design

Design model

Parallel

Treatments tested in this trial

HHK001 (Leuprorelin Acetate Microspheres for Injection)
Drug
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.
Enantone (Leuprorelin Acetate Microspheres for Injection)
Drug
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.

Treatment groups

20 Participants

are divided into 2 treatment groups

Group A: HHK001Experimental treatment 1 intervention

Group B: EnantoneActive comparator 1 intervention

Trial outcomes