NCT05876949

AVT03 With Xgeva in Healthy Male Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 208 (actual)
• Sponsor: Alvotech Swiss AG · Industry
• Sex: Male
• Age: 28 Years – 55 Years
• Healthy volunteers: Accepted

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

Detailed description

The study will consist of 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.

Conditions

• This is a Phase I Study Conducted in Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	AVT03	AVT03 will be given as 1 time subcutaneous injection
BIOLOGICAL	Denosumab	Xgeva (denosumab) will be given as 1 time subcutaneous injection

Timeline

• Start date: 2023-07-21
• Primary completion: 2024-04-15
• Completion: 2024-04-15
• First posted: 2023-05-26
• Last updated: 2025-05-15
• Results posted: 2025-05-15

Locations

3 sites across 3 countries: Poland, South Africa, United Kingdom