NCT05856630

Pharmacokinetics Pharmacodynamics and Safety of LY01022 in Patients With Prostate Cancer Compared With Zoladex® 10.8mg

A Randomized, Open-label, Parallel, Active-controlled Phase 1 Study to Compare Pharmacokinetics Pharmacodynamics and Safety of Goserelin Acetate Sustained-Release Microspheres for Injection (LY01022) With Zoladex® 10.8mg Following Single Administration in Patients With Prostate Cancer

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Luye Pharma Group Ltd. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, open-label, Parallel, active-controlled phase I study. A total of 20-24 patients with locally advanced or metastatic prostate cancer will be randomized in a 1:1 ratio to receive a single injection of LY01022 10.8mg or Zoladex® 10.8mg. Blood samples will be collected to evaluate PK and PD profiles, and safety evaluation will be conducted as required in the protocol.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Goserelin Acetate Sustained-Release Microspheres for Injection	10.8mg, Single dose, subcutaneously（SC）
DRUG	Zoladex 10.8 MG Drug Implant	10.8mg, Single dose, subcutaneously（SC）

Timeline

• Start date: 2023-05-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2023-05-12
• Last updated: 2023-05-12

Locations

1 site across 1 country: China