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NeuClone announces First Human dose of Stelara(R) (Ustekinumab) Biosimilar candidate
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NeuClone, a clinical, Oct. 21 -- stage biopharmaceutical company exclusively focused on developing high-quality biosimilar products, announced on 17 Oct 2019 that it has commenced dosing of Stelara(R) (ustekinumab) biosimilar candidate, NeuLara, in Phase I clinical trial.
The single-dose, double-blind, randomised, three-arm study is being conducted across multiple Australian sites in over 200 healthy volunteers. The primary objective is to demonstrate equivalent pharmacokinetics (PK) and the secondary objective is to demonstrate equivalent safety of NeuLara to the US- and EU-sourced Stelara(R).
NeuLara is the second biosimilar from NeuClone's pipeline to enter clinical development and is developed in partnership with Serum Institute of ...
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