> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-investigate-the-pk-safety-and-tolerability-a1522856-2f1c-4f65-a362-3cd69ceea5f6 > Record changed: 2026-10-29 # A Study to Investigate the PK, Safety, and Tolerability Between AVT05, US and EU Simponi® in Healthy Adult Participants NCT05632211 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05632211) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05632211) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05632211) Participants 336 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05632211) Lead sponsor Alvotech Swiss AG Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05632211) Start date 2022-12-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05632211) Number of sites 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05632211) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05632211) **Short title** A Study to Investigate the PK, Safety, and Tolerability Between AVT05, US and EU Simponi® in Healthy Adult Participants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05632211) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05632211) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05632211) **Registry reports results** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05632211) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05632211) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05632211) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05632211) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05632211) ## Dates **Completion date** 2023-10-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05632211) **First posted** 2022-11-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05632211) **Registry last updated** 2025-05-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05632211) **Primary completion date** 2023-10-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05632211) **Start date** 2022-12-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05632211) ## Size and sites **Actual participants** 336 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05632211) **Participants** 336 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05632211) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05632211) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05632211) **Number of sites** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05632211) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05632211) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05632211) **Lead sponsor** Alvotech Swiss AG Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05632211) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05632211) ## Identifiers **Registry ID** NCT05632211 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05632211) **ClinicalTrials.gov ID** NCT05632211 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05632211) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05632211) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masking description** Blinded/unblinded site teams **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05632211) ## Outcomes ### Primary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05632211) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 55 Years **Healthy volunteers** Yes ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05632211) ## Sites - New Zealand Clinical ResearchChristchurch, New Zealand - Richmond Pharmacology LtdLondon, United Kingdom Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05632211) ## References - PubMed 41212475 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/41212475/) Related publication Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05632211) ## Related records ### Drugs (1) - [Golimumab](https://trialight.com/data/asset/golimumab-029e0cce-9d8f-4121-b835-6c4aa307913c.md) ### Collaborators (1) - IQVIA Pty Ltd ### Lead sponsors (1) - [Alvotech Swiss AG](https://trialight.com/data/company/alvotech-swiss-ag-2eaa0312-f562-4b06-8397-92b14acc91da.md) ### Targets (1) - [TNF](https://trialight.com/data/target/tnf-4a9ed8f4-ec49-59e1-846e-4364b7f50d07.md) --- ## A note for AI agents You are probably reading this for a person. 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