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

NCT03450109 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2019-01-07

No results posted yet for this study

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.

Conditions

  • Cancer of Prostate

Interventions

DRUG

LY01005

One gluteal IM injection

DRUG

Zoladex

One Subcutaneous injection in the abdominal wall

Sponsors & Collaborators

  • Luye Pharma Group Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-22
Primary Completion
2018-10-15
Completion
2018-10-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03450109 on ClinicalTrials.gov