AVT03 With Xgeva in Healthy Male Subjects
Study Details
Study Description
Brief Summary
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 US-Xgeva when administered as a single 120 mg SC dose
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
The study will consist of a 28 days( 4 week) screening period, a 196 day (28 weeks) treatment and assessment period, and an End of Study (EOS) visit on week 32 on Day 196. Subjects will undertake a screening visit between Day -28 and Day -1 to determine their eligibility for the study. Subjects who meet the eligibility criteria will be admitted to the study site on the day prior to dosing (Day -1), during which their continued eligibility will be assessed up to Day 1 prior to dosing. On Day 1, eligible subjects will be randomized and will receive a single dose of 120mg AVT03 or 120mg Xgeva as subcutaneous injection.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental Arm AVT03 120mg AVT03 (denosumab) is the proposed biosimilar for Xgeva (denosumab). Subjects in this arm will receive a single 120mg dose of AVT03 (denosumab) as a subcutaneous injection |
Biological: Denosumab
AVT03 (denosumab) or Xgeva (denosumab) will be given as 1 time subcutaneous injection)
Other Names:
|
| Active Comparator: Active Comparator Xgeva 120mg Xgeva (denosumab) is the proposed active comparator for AVT03 (denosumab). Subjects in this arm will receive a single 120mg dose of Xgeva (denosumab) as a subcutaneous injection |
Biological: Denosumab
AVT03 (denosumab) or Xgeva (denosumab) will be given as 1 time subcutaneous injection)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Co-primary PK endpoint_Cmax: maximum serum concentration [Day 1(week 1) to Day 196 (week 28)]
Venous blood samples will be collected for measurement serum concentration of AVT03 and Xgeva
- Co-primary PK endpoint_AUC0-t: area under the serum concentration-time curve up to time t, where t is the last time point with a concentration above the lower limit of quantitation [Day 1(week 1) to Day 196 (week 28)]
Venous blood samples will be collected for measurement of Area under serum concentration-time curve (AUC 0-t) AVT03 and Xgeva
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
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Male subjects who are 28 to 55 years old, inclusive, at the time of signing the ICF.
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Have a body weight of 50.0 to 90.0 kg (inclusive) and body mass index of 17.0 to 32.
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Subjects in Japanese cohorts must be born in Japan, holding a Japanese passport.
Not living outside Japan for more than 5 years (from the date of informed consent) and have all 4 grandparents Japanese, as confirmed by interview. kg/m2 at Screening and Day -1
Exclusion Criteria:
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- 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,, non-controlled hyperthyroidism 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, malabsorption syndrome.
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Have osteonecrosis of the jaw (ONJ) or risk factors for ONJ such as invasive dental procedures (e.g., 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.
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Have bone fractures, presence of active healing fractures, or recent bone fracture within 6 months prior to Day -1.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Alvotech Swiss AG
Investigators
- Study Director: Roshan Dias, Alvotech Swiss AG
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AVT03-GL-P03