BioCentury
ARTICLE | Clinical News

TKM-Ebola: Phase I hold

July 21, 2014 7:00 AM UTC

Tekmira said FDA placed a full clinical hold on a single-blind, placebo-controlled, U.S. Phase I trial of IV TKM-Ebola after the company completed the single ascending-dose portion of the trial, which evaluated doses of 0.075-0.3 mg/kg in 19 healthy volunteers. According to the company, FDA requested additional data related to the mechanism of cytokine release that was observed in a single volunteer at higher doses and a protocol modification to ensure the safety of the volunteers before Tekmira begins the multiple ascending-dose portion.

Tekmira said it is assembling data and information to submit to FDA, but said it is not able to say when the hold will be lifted. The multiple ascending-dose portion plans to evaluate 0.06, 0.12 and 0.24 mg/kg TKM-Ebola in 12 volunteers. ...