French biotechnology company Transgene has dosed the first patient in a Phase l clinical trial in China to assess T101 for the treatment of chronic hepatitis B virus (HBV) infection.
The randomised, single-centre, double-blind, placebo-controlled trial is designed to examine T101 in patients who are being treated for chronic HBV infection with standard-of-care antiviral therapy.
The primary objective of the trial is to validate the tolerability of T101 given in single and multiple ascending doses.
Up to 36 people will be enrolled in the trial, which also aims to assess the immunogenicity of T101 in a patient group whose characteristics differ from European and North American patients and who can be infected with different genotypes of the virus.
Initial data from the study is expected at the beginning of next year.
Through its joint venture with Tasly Pharmaceutical Group, Transgene is currently developing T101 in China.
T101 is a targeted immunotherapy candidate for treating of chronic hepatitis B, based on a viral vector expressing three HBV antigens and Transgene’s therapeutic vaccine TG1050.
In addition, Transgene has been evaluating TG1050 in a Phase l/lb trial in chronic HBV patients treated with standard-of-care antiviral therapies in Europe and Canada.
Initial results from this trial have confirmed the tolerability profile of TG1050.
The trial has also shown the dose-related immunogenicity of TG1050 following a single administration to patients with chronic hepatitis B receiving standard antiviral therapy.