At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 208 enrolled
Drug / intervention
AVT03 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating AVT03 and Denosumab for This is a Phase I Study Conducted in Healthy Volunteers. Completed, enrolled 208 participants across 3 sites in 3 countries.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPoland, South Africa, United Kingdom
Collaborators--
Timeline
Phase 1CompletedFinished
202420252026
First PostedMay 2023
Enrollment StartJul 2023
Primary CompletionApr 2024
TodayJul 2026
First PostedMay 26, 2023
Enrollment StartJul 21, 2023
Primary CompletionApr 15, 2024
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 3.1 years ago
Interventions
AVT03biological
AVT03 will be given as 1 time subcutaneous injection
Denosumabbiological
Xgeva (denosumab) will be given as 1 time subcutaneous injection