drugset / Trial / NCT05140512

Pharmacokinetics, Pharmacodynamics and Safety of LY01005 in Patients With Prostate Cancer Compared to ZOLADEX®

NCT05140512

Phase 1 Completed 23 enrolled Luye Pharma Group Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a randomized, open-label and parallel phase I study to compare pharmacokinetics (PK), pharmacodynamics (PD) and safety of goserelin acetate sustained-release microspheres for injection (LY01005) and ZOLADEX® following multiple administration in patients with prostate cancer.

Timeline

Start
2021-02-04
Primary completion
2021-09-15
Completion
2021-11-26

Drugs

EvaluationDrugModalityDoseRoute
Comparator Goserelin Other / unclassified 3.6 mg Subcutaneous
Subject LY01005 Unknown 3.6 mg Intramuscular

Indications