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A Pharmacokinetic Similarity Study in Healthy Male Subjects to Evaluate Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of LY06006 Versus US-Prolia and EU-Prolia by Single-dose Subcutaneous Injection

NCT06095427 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2023-10-23

No results posted yet for this study

Summary

This trial is a randomized, double-blind, three-arm, parallel-group, pharmacokinetic study. The purpose of this study is to demonstrate pharmacokinetic (PK) similarity and to compare safety, immunogenicity and pharmacodynamics (PD) between the test product L06006 and the reference products US-Prolia and EU-Prolia in healthy male subjects. A total of 300 healthy male subjects aged 28 to 65 years (both inclusive) will be randomized 1:1:1 to receive a single subcutaneous (s.c.) injection of either LY06006 or US-Prolia or EU-Prolia on Day 1 and then be followed for 36 weeks.

Conditions

  • Healthy

Interventions

BIOLOGICAL

LY06006 (Denosumab Biosimilar)

single dose of 60 mg LY006006 s.c.

BIOLOGICAL

US-Prolia (Denosumab)

single dose of 60 mg US-Prolia s.c.

BIOLOGICAL

EU-Prolia

single dose of 60 mg EU-Prolia s.c.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • Luye Pharma Group Ltd.

    lead INDUSTRY

Principal Investigators

  • R Fuhr, MD · Parexel

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
28 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-09
Primary Completion
2023-03-14
Completion
2023-03-14
FDA Drug
Yes

Countries

  • Germany

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 NCT06095427 on ClinicalTrials.gov