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.

“The primary objective of the trial is to validate the tolerability of T101 given in single and multiple ascending doses.”

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.