A Study to Compare the Pharmacokinetic, Pharmacodynamics, safety, Tolerability and Immunogenicity of BP16 versus Prolia (US and EU approved) in Healthy male Volunteers. - Trial ANZCTR12623000520639

Timeline & Enrollment

Primary Outcome

Pharmacokinetic assessment will be done by AUC (0-inf), Cmax, AUC (0-t), % AUC ext, Tmax, T (1/2), first-order terminal elimination rate constant, Apparent systemic clearance (CL/F) and Apparent volume of distribution (Vd/F). Yes Blood samples will be collected to assess the Pk, PD and Immunogenicity ;; Pharmacodynamic assessment will be done by quantification of Serum type 1 C-telopeptide (CTX1) levels ;; Safety Assessment will be done by clinical Safety Laboratory Assessments (measuring Hematology assessment, Clinical Chemistry, Coagulation Profile, Urinalysis and Urinalysis), electrocardiograms and injection site reaction

Summary

A Randomized, Double-Blind, Parallel group, Comparative Phase I study for the assessment of Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of BP16 versus US licensed - Prolia® and EU approved - Prolia® Following a Single dose (60mg/mL) Subcutaneous Administration in Healthy Male Volunteers This is a phase 1 , multi centre randomized double blinded clinical trial in healthy male volunteers Primary objective is to assess the Pharmacokinetic similarity and to establish the Bioequivalence between the BP16 versus US licensed - Prolia® and EU approved - Prolia® Following a Single dose (60mg/mL) Subcutaneous Administration in Healthy Male Volunteers Secondary objective is to assess the Pharmacodynamic similarity , to monitor the safety ,tolerability and to assess the immunogenicity between the BP16 versus US licensed - Prolia® and EU approved - Prolia® Following a Single dose (60mg/mL) Subcutaneous Administration in Healthy Male Volunteers 204 Subjects will be enrolled and randomized in 1:1:1 ratio to receive the single dose subcutaneous injection of BP16/EU Prolia /US Prolia .

ICD-10 Classifications