Trials & Filings

Discovery Labs Cleared For IIa/b Aerosurf Trial

Will begin testing against RDS

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Discovery Laboratories’ IND for Aerosurf has been cleared by the FDA, enabling the company to initiate its Phase II trial. The trial is expected to include two studies. The primary goal of the initial study, Phase IIa, is to evaluate the safety and tolerability of a single exposure of aerosolized KL4 surfactant drug product.  This study is planned as an escalating dose study evaluating three dose levels of aerosolized KL4 surfactant. The comparator is nCPAP alone. The study will be conducted in ...

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