NCT06095427 - 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 | Biotech Hunter

Enrollment

300

Participants

Timeline

Start Date

March 9, 2021

Primary Completion Date

March 14, 2023

Study Completion Date

March 14, 2023

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.

Trial Locations (2)

Parexel International GmbH, Early Phase Clinical Unit Berlin, Berlin

CTC North GmbH & Co KG, Hamburg