This study has been designed as a randomized, double-blind, single-dose, parallel-group study in healthy adult male subjects 28 years to 55 years old. The study will assess the PK, PD, safety, tolerability and immunogenicity of AVT03 compared to Prolia when administered as a single SC dose.
The study will consist of a 4 week screening period, a 252 day (36 weeks) treatment and assessment period, and an End of Study (EOS) visit on week 36 on Day 252. Subjects will undertake a screening visit between Day -28 and Day -1 to determine their eligibility for the study. On Day 1, eligible subjects will be randomized and will receive a single dose of AVT03 or Prolia as subcutaneous injection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
209
Nucleus Network
Herston, Australia
NZCR Christchurch
Christchurch, Christchuch, New Zealand
NZCR Auckland
Auckland, New Zealand
Farmovs
Bloemfontein, South Africa
Area under the serum concentration-time curve (AUC0-last) from day 0 to day 252
Venous blood samples will be collected for measurement of Area under serum concentration-time curve (AUC 0-t) AVT03 and Prolia
Time frame: Day 1(week 1) to Day 252 (week 36)
Area under the serum concentration-time curve (AUC0-inf) from day 0 to day 252
Venous blood samples will be collected for measurement of CTX-1 serum biomarker for AVT03 and Prolia.
Time frame: Time Frame: Day 1(week 1) to Day 252 (week 36)]
Maximum serum concentration Cmax from day 0 to day 252
Venous blood samples will be collected for measurement of maximum serum concentration (Cmax) of AVT03 and Prolia.
Time frame: Day 1(week 1) to Day 252 (week 36)
PD_AUCE0 for CTX-1 (% inhibition)
Venous blood samples will be collected for measurement of serum concentration of AVT03 and Prolia
Time frame: Day 1(week 1) to Day 252 (week 36)
PK area under the concentration-time curve (AUC0-24) from Day 0 to Day 252
Venous blood samples will be collected for measurement of serum concentration of AVT03 and Prolia
Time frame: Day 1(week 1) to Day 162 (week 24)]
Safety incidence, nature and severity of adverse events
Time frame: Screening to Day 252 (week 36)
Immunogenicity presence and titers of ADAs and presence of nAbs against AVT03 and Prolia
Venous blood samples will be collected for measurement of antidrug-antibodies against of AVT03 and Prolia
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Time frame: Time Frame: Day 1(week 1) to Day 252 (week 36)