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AVT03 With Prolia in Healthy Male Subjects

NCT05126784 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 209

Last updated 2024-05-29

No results posted yet for this study

Summary

This study has been designed as a randomized, double-blind, single-dose, parallel-group study in healthy adult male subjects 28 years to 55 years old. The study will assess the PK, PD, safety, tolerability and immunogenicity of AVT03 compared to Prolia when administered as a single SC dose.

Conditions

  • Healthy Male Subjects

Interventions

BIOLOGICAL

AVT03

AVT03 (biosimilar to denosumab) will be given as single subcutaneous injection

BIOLOGICAL

Prolia

Prolia (denosumab) will be given as single subcutaneous injection

Sponsors & Collaborators

  • Alvotech Swiss AG

    lead INDUSTRY

Principal Investigators

  • Felicitas Bullo · Alvotech

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
2022-06-29
Primary Completion
2023-10-16
Completion
2023-10-16

Countries

  • Australia
  • New Zealand
  • South Africa

Study Locations

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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 NCT05126784 on ClinicalTrials.gov