Phase 1 N=208 Randomized Quadruple-blind Other

AVT03 With Xgeva in Healthy Male Subjects

This is a Phase I Study Conducted in Healthy Volunteers

Bottom Line

View on ClinicalTrials.gov: NCT05876949 ↗

Enrolled (actual)

208

Serious AEs

1.9%

Results posted

May 2025

Primary outcome: Primary: Co-primary PK Endpoint Cmax: Maximum Serum Concentration — 12761.4; 12259.8 ng/mL

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: AVT03 (Biological); Denosumab (Biological)
Age: Adult · 28+ yrs
Sex: Male
Sponsor: Alvotech Swiss AG
Primary completion: Apr 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Co-primary PK Endpoint Cmax: Maximum Serum Concentration	12761.4; 12259.8	—
PRIMARY 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	15501387.9; 14366056.2	—
SECONDARY PK_ AUC0-inf: Comprised of AUC0-t and AUC Extrapolated From Time t to Time Infinity.	15559245.8; 14555779.3	—
SECONDARY Safety Incidence, Nature and Severity of Adverse Events.	66; 67; 1; 3	—
SECONDARY Immunogenicity Presence of ADAs and Presence of nAbs Against AVT03 and Xgeva	104; 102; 41; 43	—

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

Eligibility 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.
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.

Exclusion Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05876949). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.