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

StatusNot Yet Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07793162
Lead Sponsor The Third Xiangya Hospital of Central South University
Collaborators: Zhuhai Huahaikang Pharmaceutical Technology Co., Ltd.
Conditions
(from sponsor)		 Endometriosis
Related terms Endometriosis
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov