MedTrace Logo

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

NCT05856630 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-05-12

No results posted yet for this study

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

Interventions

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）

Sponsors & Collaborators

  • Luye Pharma Group Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-31
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT05856630 on ClinicalTrials.gov