ARTICLE | Clinical News

Protectan: Preliminary Phase Ib data

October 11, 2010 7:00 AM UTC

Top-line data from a Phase Ib trial in 100 healthy volunteers showed that 4 dosing regimens of CBLB502 were well tolerated and produced rapid cytokine responses. Additionally, single intramuscular injections of CBLB502 displayed a dose-proportional biomarker response. There was no difference in the adverse event profile between dosing regimens. The most common adverse event reported was transient flu-like syndrome, which the company said was consistent with what was observed in the previous Phase I safety trial and which generally resolved within 24 hours. Subjects received a single injection of 25 or 35 µg CBLB502, a single dose of 400 mg ibuprofen followed by 35 µg CBLB502, or two 30 µg doses of CBLB502 given 72 hours apart. ...