NCT03450109

A Study to Assess LY01005 Versus Goserelin Comparator (ZOLADEX®) in Patients With Prostate Cancer

A Randomized and Open-label Study to Assess Pharmacokinetics, Pharmacodynamics and Safety of LY01005 Versus Goserelin Comparator (ZOLADEX®) Following a Single Administration in Patients With Prostate Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Luye Pharma Group Ltd. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A phase I, randomized, open-label and active-control study to assess the PK, PD and safety profiles of LY01005 versus goserelin comparator to be conducted in the USA.

Detailed description

This will be a randomized, open-label and active-control study to assess the PK, PD and safety profiles of LY01005 versus goserelin comparator to be conducted in the USA.

Conditions

• Cancer of Prostate

Interventions

Type	Name	Description
DRUG	LY01005	One gluteal IM injection
DRUG	Zoladex	One Subcutaneous injection in the abdominal wall

Timeline

• Start date: 2017-12-22
• Primary completion: 2018-10-15
• Completion: 2018-10-30
• First posted: 2018-03-01
• Last updated: 2019-01-07

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study