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AVT03 With Xgeva in Healthy Male Subjects

NCT05876949 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2025-05-15

Study results available
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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

Conditions

  • This is a Phase I Study Conducted in Healthy Volunteers

Interventions

BIOLOGICAL

AVT03

AVT03 will be given as 1 time subcutaneous injection

BIOLOGICAL

Denosumab

Xgeva (denosumab) will be given as 1 time subcutaneous injection

Sponsors & Collaborators

  • Alvotech Swiss AG

    lead INDUSTRY

Principal Investigators

  • Felicitas Bullo · Alvotech Swiss AG

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
28 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-21
Primary Completion
2024-04-15
Completion
2024-04-15

Countries

  • Poland
  • South Africa
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05876949 on ClinicalTrials.gov