Phase 1 Trial of TCN-032, a Therapeutic Antibody Against Influenza A
Theraclone Sciences announced positive results from its Phase 1 study of TCN-032 (anti-Influenza A mAb), for the treatment of influenza A infections at the 52nd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). The randomized, double-blind, placebo-controlled Phase 1 study enrolled 40 healthy adult volunteers in 5 single-dose cohorts. Each cohort consisted of 8 patients, 6 receiving TCN-032 and 2 receiving placebo. Dose levels tested were 1, 3, 10, 20 and 40 mg/kg. Subjects were monitored up to 60 days after study drug infusion for clinical and laboratory evaluations, pharmacokinetics (TCN-032 blood levels) and anti-drug antibody levels.
No serious adverse events were observed with TCN-032; most adverse events observed were mild to moderate and unrelated to the study drug. Pharmacokinetic evaluation demonstrated dose proportionality, half-life of approximately 15 days and other parameters consistent with an IgG antibody therapeutic. In addition, TCN-032 showed no signs of immunogenicity. A proof-of-concept Phase 2 study in human subjects is planned to initiate by the end of 2012.
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