Trial reportBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2026
Pharmacokinetic Similarity of Biosimiliar AVT05 Versus Reference Product Golimumab in Healthy Adults: A Double-Blind, Three-Arm, Parallel-Group Study.
Trial report in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05632211 (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), which is not on this map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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
Who cites it
1 citing paper in PubMed.
- Biosimilars in Adult and Pediatric Noninfectious Uveitis.Clinical ophthalmology (Auckland, N.Z.) · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAVT05, a recombinant, human, immunoglobulin G1қ monoclonal antibody, is a biosimilar to Simponi
objectivesThe purpose of this study was to investigate the pharmacokinetic (PK) similarity, safety, tolerability, and immunogenicity between AVT05 and US-licensed and European Union (EU)-approved reference product (RP) golimumab (US-RP and EU-RP, respectively) in healthy adult participants.
methodsThree hundred and thirty-six healthy male and female participants aged 18-55 years were randomized in a 1:1:1 ratio to AVT05, US-RP, or EU-RP. Participants received a single 50 mg/0.5 mL subcutaneous injection on Day 1 and were followed until Day 75. The primary PK endpoints were maximum serum concentration (C
resultsDemographic and baseline characteristics were balanced between the treatment groups. The 90% confidence intervals for the geometric means ratio for the protein-adjusted primary PK parameters were entirely contained within the prespecified margins of 80.00% and 125.00% (C
conclusionsFollowing single-dose administration, the study supported a demonstration of PK similarity between AVT05 and EU-RP and US-RP in healthy participants. Safety, tolerability, and immunogenicity profiles were comparable between the treatment arms. CLINICAL
trial registrationThe trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT05632211).
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