Overview

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

Status:
Not yet recruiting

Trial end date:
2023-12-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 1

Details

Lead Sponsor:

Luye Pharma Group Ltd.

Treatments:

Goserelin