For Healthcare Professionals

AVT03 With Prolia in Healthy Male Subjects


About the study

This study has been designed as a randomized, double-blind, parallel-group study and in healthy adult male subjects of age 28 years to 55 years old. The study will assess the PK, PD, safety and tolerability of AVT03 compared to Prolia when administered as a single 60 mg SC dose

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


Inclusion Criteria:

  1. Male subjects who are 28 to 55 years old, inclusive
  2. Have a body weight of 50.0 to 90.0 kg (inclusive) and body mass index (BMI) of 17.0 to 32.0 kg/m2 (inclusive)at Screening and Day -1
  3. Medical history without evidence of a clinically significant disorder, condition, or disease that, in the opinion of the Investigator, would pose a risk to subject safety


Exclusion Criteria:

  1. Any evidence of clinically relevant pathology, especially prior diagnosis of bone disease, or any uncontrolled condition that will affect bone metabolism (such as, but not limited to osteoporosis, osteogenesis imperfecta, hyperparathyroidism, hyperthyroidism, hypothyroidism, osteomalacia, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, current flare-up of osteoarthritis and/or gout, active malignancy, renal disease [defined as glomerular filtration rate <45 mL/min], Paget's disease of the bone, recent bone fracture [within 6 months], and malabsorption syndrome)
  2. Have osteonecrosis of the jaw (ONJ) or risk factors for ONJ such as invasive dental procedures (eg, tooth extraction, dental implants, oral surgery) within 6 months prior to Day 1 or intend to undergo such procedures during the study period, poor oral hygiene, periodontal, and/or pre existing dental disease
  3. Have bone fractures within 6 months prior to Day -1.
  4. Have a history of immunodeficiency
  5. Those with skin allergies, or are susceptible to autoinflammatory skin disorders, or prone to the development of allergic skin inflammation
  6. Abnormal serum calcium: current hypocalcemia or hypercalcemia at Screening. Serum calcium levels must be within reference ranges.
  7. Known vitamin D deficiency (25[OH]D levels <15 ng/mL [37.5 nmol/L]) after supplementation at Screening
  8. Known intolerance to calcium or vitamin D supplements
  9. Any current active infections, including localized infections, or any recent history (within 1 week prior to IP administration) of active infections, cough or fever, or a history of recurrent or chronic infections
  10. Known or suspected clinically relevant drug hypersensitivity to denosumab or any of its constituents, which in the opinion of the Investigator, contraindicates the subject's participation
  11. History or presence of malignancy (except for successfully treated basal or squamous cell carcinoma)
  12. Recent history of major surgery within 3 months prior to Day -1 and/or plan to have an operation (including invasive dental procedures) during the study period
  13. Receipt of any investigational agent or drug within 8 weeks or 5 half-lives of that drug, whichever is longer, prior to IP administration in the current study
  14. Previous treatment with denosumab (Prolia/Xgeva or its biosimilars)
  15. Other criteria may apply

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Study Locations

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How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details


Healthy Male Subjects

Age (in years)

28 - 55


Phase 1

Participants needed


Est. Completion Date

Dec 20, 2023

Treatment type



Alvotech Swiss AG identifier


Study number


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