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About
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.
Enrollment
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Inclusion criteria
Highly effective forms of birth control include (i.e., less than 1% failure rate per year when used consistently and correctly):
Acceptable methods of surgical sterilization are:
Barrier methods of birth control:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
300 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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