2-way crossover bioavailability study of Aotaner in Healthy Volunteers
Research type
Research Study
Full title
A randomized, double blind, two-way cross-over study to evaluate the bioavailability of Aotaner and Enbrel® (EU-licensed) following a single dose of 50 mg (25 mg/0.5 mL x 2) subcutaneous injection in healthy male and female subjects
IRAS ID
276582
Contact name
Pablo Forte-Soto
Contact email
Sponsor organisation
Aocean Biopharma
Eudract number
2019-004567-47
Duration of Study in the UK
0 years, 4 months, 3 days
Research summary
This study will compare Aotaner to a product already on the market, namely Enbrel®. Both products contain etanercept as the active substance. Aotaner is being developed to be a similar biological medicinal product (“biosimilar”) to the reference product Enbrel®, which is a drug already approved for the treatment of certain autoimmune diseases (diseases where the body's immune system attacks normal tissues, causing inflammation), such as e.g. rheumatoid arthritis (inflammation of the joints) and psoriasis (inflammation of the skin). Aotaner and Enbrel® inhibit inflammatory reactions by binding to certain proteins in the body, which decreases the immune response. It is expected that the treatment effects of Aotaner will be similar in comparison to Enbrel®.
The main purpose of this study is to compare the study drug (Aotaner) with the comparator drug (Enbrel®) to evaluate if they are bioequivalent, by investigating how the 2 drugs are taken up by the body, metabolized (chemically broken down), distributed through the body and excreted in healthy subjects (this is called pharmacokinetics). The study will also investigate how safe both drugs are, and how well they are tolerated after dosing. In addition, it will be investigated to what extent the study drug and the comparator drug can trigger a reaction of the immune system. This is called immunogenicity.
This is a 2-way cross-over, single-blind study Phase I, single-centre study in 54 healthy male and female volunteers. The study includes a screening visit, 2 treatment periods and a follow-up visi. Volunteers will receive a single 50 mg (25 mg/0.5 mL x 2) subcutaneous (under the skin) dose of Aotaner or Enbrel® on Day 1 of each of the 2 treatment periods. The order of the treatment periods will be randomly assigned and the 2 dose administrations will be separated by at least 35 days.
REC name
London - Brent Research Ethics Committee
REC reference
20/LO/0007
Date of REC Opinion
6 Feb 2020
REC opinion
Favourable Opinion