Phase 1
Completed N=336
A Study to Investigate the PK, Safety, and Tolerability Between AVT05, US and EU Simponi® in Healthy Adult Participants
Healthy Adult Subjects
Source: ClinicalTrials.gov NCT05632211 ↗
Enrolled (actual)
336
Serious AEs
0.6%
Results posted
May 2025
Primary outcomePrimary: 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 — 3453.8; 3468.6; 3567.1 ng/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
1423639; 1362263; 1414744 | — |
| PRIMARY 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 |
1423639; 1362263; 1414744 | — |
Eligibility Criteria
Inclusion Criteria
- 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).
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT05632211). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.