AVT03 With Xgeva in Healthy Male Subjects
- 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, safety and tolerability of AVT03 compared to US-Xgeva when administered as a single 120 mg SC dose
- Short title
- AVT03 With Xgeva in Healthy Male Subjects
- Official title
- A Randomized, Double-blind, Parallel Design, Single Dose, 2-arm Study Comparing the Pharmacokinetic, Safety and Immunogenicity Profiles of AVT03 and US-Xgeva® in Healthy Male Subjects
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2024-04-15
- First posted
- 2023-05-26
- Registry last updated
- 2025-05-15
- Primary completion date
- 2024-04-15
- Start date
- 2023-07-21
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Alvotech Swiss AG
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05876949
- ClinicalTrials.gov ID
- NCT05876949
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Other
- Masking
- Quadruple masking
- Masking description
- Double Blind
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Co-primary PK Endpoint Cmax: Maximum Serum Concentration
Timeframe: Day 1 (pre-dose, 8h and 12h post-dose), Day 2 to Day 13 (daily), Day 15, Day 18, Day 22, Day 25, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 112, Day 126, Day 141, Day 162 and Day 196 (week 28) / End of study
Samples will be collected for measurement
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
Timeframe: Day 1 (pre-dose, 8h and 12h post-dose), Day 2 to Day 13 (daily), Day 15, Day 18, Day 22, Day 25, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 112, Day 126, Day 141, Day 162 and Day 196 (week 28) / End of study
Samples will be collected for measurement
PK_ AUC0-inf: Comprised of AUC0-t and AUC Extrapolated From Time t to Time Infinity.
Timeframe: Day 1 (pre-dose, 8h and 12h post-dose), Day 2 to Day 13 (daily), Day 15, Day 18, Day 22, Day 25, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 112, Day 126, Day 141, Day 162 and Day 196 (week 28) / End of study
Samples will be collected for measurement
Safety Incidence, Nature and Severity of Adverse Events.
Timeframe: Day 1(week 1) to Day 196 (week 28)]
Immunogenicity Presence of ADAs and Presence of nAbs Against AVT03 and Xgeva
Timeframe: Day 1, Day 8, Day 15, Day 29, Day 57, Day 71, Day 112, Day 141, Day 196/EoS
Samples will be collected for measurement
- Sex
- Male
- Age groups
- Adults
- Minimum age
- 28 Years
- Maximum age
- 55 Years
- Healthy volunteers
- Yes
- 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.
- Male subjects who are 28 to 55 years old, inclusive, at the time of signing the ICF.
- Have a body weight of 50.0 to 90.0 kg (inclusive) and body mass index of 17.0 to 32 kg/m2 at Screening and Day -1.
- 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, Paget's disease of the bone, malabsorption syndrome.
- Have osteonecrosis of the jaw (ONJ) or risk factors for ONJ such as invasive dental procedures (e.g., tooth extraction, dental implants, oral surgery) or intend to undergo such procedures during the study period, poor oral hygiene, periodontal, and/or pre-existing dental disease.
- Have bone fractures, presence of active healing fractures, or recent bone fracture
- Abnormal serum calcium.
- Known vitamin D deficiency.
- BiokineticaJózefów, Poland
- FarmovsBloemfontein, South Africa
- Richmond PharmacologyLondon, United Kingdom
- PubMed 40357869Related publication