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

NCT05632211
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Phase
Phase 1
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Recruitment status
Completed
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Participants
336
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Lead sponsor
Alvotech Swiss AG
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Start date
2022-12-16
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Number of sites
2
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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.
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Short title
A Study to Investigate the PK, Safety, and Tolerability Between AVT05, US and EU Simponi® in Healthy Adult Participants
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Official title
A First-in-human, Randomized, Parallel Group, Double-blind, 3-arm Study to Investigate the Comparative PK, Safety, and Tolerability Between Subcutaneous AVT05, US-licensed Simponi®, and EU-approved Simponi® in Healthy Adult Participants
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Control arm
Active comparator
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Registry reports results
Yes
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 1
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Study type
Interventional
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Completion date
2023-10-03
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First posted
2022-11-30
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Registry last updated
2025-05-28
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Primary completion date
2023-10-03
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Start date
2022-12-16
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Actual participants
336
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Participants
336
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Participant count basis
Actual
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Protocol amendments
2
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Number of sites
2
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Alvotech Swiss AG
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05632211
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ClinicalTrials.gov ID
NCT05632211
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masking description
Blinded/unblinded site teams
Masked roles
Participants, Investigators
Sources for study design
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  1. To Demonstrate the PK Similarity of AVT05 With US Licensed and EU Approved Simponi and the PK of EU Approved Simponi With US Licensed Simponi

    Timeframe: Day zero to day 75 - days 1 (within the hour prior to dosing and at 8 and 12 hours post-dose), 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 22, 29, 36, 43, 50, 57, 64, and 75.

    The primary PK parameters to be compared is Cmax and AUC0-inf.

  2. To Demonstrate the PK Similarity of AVT05 With US Licensed and EU Approved Simponi and the PK of EU Approved Simponi With US Licensed Simponi

    Timeframe: Day zero to day 75 - days 1 (within the hour prior to dosing and at 8 and 12 hours post-dose), 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 22, 29, 36, 43, 50, 57, 64, and 75.

    The primary PK parameter to be compared is AUC0-inf

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults
Minimum age
18 Years
Maximum age
55 Years
Healthy volunteers
Yes

  • Healthy participants capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in the protocol.
  • Participants must be 18 to 55 years old (inclusive) at the time of signing the ICF.
  • Have a body weight of 50.0 to 90.0 kg (inclusive) and body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive).

  • Have a history of relevant drug and/or food allergies.
  • Known or suspected clinically relevant drug hypersensitivity to golimumab, AVT05, or any of its constituents, which in the opinion of the PI, contraindicates the participant's participation.
  • Have any past or concurrent medical conditions that could potentially increase the participant's risks or that would interfere with the study evaluation, procedures, or study completion. Examples of these include medical history with evidence of clinically relevant pathology (eg, malignancies or demyelinating disorders).
  • Previous exposure to other TNF-α inhibitors including golimumab.
Sources for eligibility
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  • New Zealand Clinical ResearchChristchurch, New Zealand
  • Richmond Pharmacology LtdLondon, United Kingdom
Sources for sites
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Sources for references
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Related records

Drugs (1)

Collaborators (1)

Lead sponsors (1)

Targets (1)