Healthy Male Subjects Clinical Trial
Official title:
A Randomized, Double-blind, Single-dose, Parallel-group Design, 2 Arm Study Comparing the Pharmacokinetic, Pharmacodynamic, Safety, Tolerability, and Immunogenicity Profiles of AVT03 and Prolia® in Healthy Male Subjects
Verified date | May 2024 |
Source | Alvotech Swiss AG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 209 |
Est. completion date | October 16, 2023 |
Est. primary completion date | October 16, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 28 Years to 55 Years |
Eligibility | Inclusion Criteria: - Male subjects who are 28 to 55 years old, inclusive - 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 - 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: - 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, Paget's disease of the bone, recent bone fracture [within 6 months], and malabsorption syndrome) - 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 - Have bone fractures within 6 months prior to Day -1. - Have a history of immunodeficiency - Those with skin allergies, or are susceptible to autoinflammatory skin disorders, or prone to the development of allergic skin inflammation - Abnormal serum calcium: current hypocalcemia or hypercalcemia at Screening. Serum calcium levels must be within reference ranges. - Known vitamin D deficiency |
Country | Name | City | State |
---|---|---|---|
Australia | Nucleus Network | Herston | |
New Zealand | NZCR Auckland | Auckland | |
New Zealand | NZCR Christchurch | Christchurch | Christchuch |
South Africa | Farmovs | Bloemfontein |
Lead Sponsor | Collaborator |
---|---|
Alvotech Swiss AG |
Australia, New Zealand, South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Day 1(week 1) to Day 252 (week 36) | |
Primary | 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: Day 1(week 1) to Day 252 (week 36)] | |
Primary | 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. | Day 1(week 1) to Day 252 (week 36) | |
Secondary | PD_AUCE0 for CTX-1 (% inhibition) | Venous blood samples will be collected for measurement of serum concentration of AVT03 and Prolia | Day 1(week 1) to Day 252 (week 36) | |
Secondary | 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 | Day 1(week 1) to Day 162 (week 24)] | |
Secondary | Safety incidence, nature and severity of adverse events | Screening to Day 252 (week 36) | ||
Secondary | 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 | Time Frame: Day 1(week 1) to Day 252 (week 36) |
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