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A Study to Investigate the PK, Safety, and Tolerability Between AVT05, US and EU Simponi® in Healthy Adult Participants

NCT05632211 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 336

Last updated 2025-05-28

Study results available
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Summary

Rationale:

Alvotech is developing AVT05 globally as a proposed biosimilar to the reference product Simponi (golimumab) for subcutaneous (SC) use. This is a first-in-human (FIH) clinical study with AVT05. The study aims to demonstrate pharmacokinetic (PK) similarity of the proposed biosimilar test product AVT05 and the reference products EU approved Simponi and US-licensed Simponi, in addition to evaluating the safety and tolerability of AVT05, when administered as a single 50 mg/0.5 mL SC dose.

Conditions

  • Healthy Adult Subjects

Interventions

BIOLOGICAL

AVT05

Pre filled syringes filled with AVT05

BIOLOGICAL

Simponi

Pre filled syringes filled with Simponi

Sponsors & Collaborators

  • Iqvia Pty Ltd

    collaborator INDUSTRY

  • Alvotech Swiss AG

    lead INDUSTRY

Principal Investigators

  • Chris Wynne · New Zealand Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-16
Primary Completion
2023-10-03
Completion
2023-10-03
FDA Drug
Yes

Countries

  • New Zealand
  • United Kingdom

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 NCT05632211 on ClinicalTrials.gov