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

Sponsor
The Third Xiangya Hospital of Central South University
Study ID
NCT07793162
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Aug 28, 2026
Start date
Aug 31, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

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

Arms

  • Experimental: HHK001
    Participants receive a single subcutaneous injection of HHK001 (Leuprorelin Acetate Microspheres for Injection) 3.75 mg at the lower edge of the deltoid muscle of the upper arm on Day 1 to Day 5 of the menstrual period. Post-dose blood sampling and follow-up last 10 weeks (through Day 70). Approximately 10 participants.
  • Active Comparator: Enantone
    Participants receive a single subcutaneous injection of Enantone (Leuprorelin Acetate Microspheres for Injection) 3.75 mg at the lower edge of the deltoid muscle of the upper arm on Day 1 to Day 5 of the menstrual period. Post-dose blood sampling and follow-up last 6 weeks (through Day 42). Approximately 10 participants.

Primary Outcome Measure

Maximum Plasma Concentration (Cmax) of Leuprorelin [ Time Frame: Pre-dose on Day 1 and post-dose sampling: Day 1 (dense sampling), Days 2, 3, 5, 8, 11, 14, 21, 25, 29, 35, and 42 (both groups); additional sampling on Days 49, 57, 63, and 70 (HHK001 group only) ]

Central Contacts

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