May 12, 2014. AllaChem, LLC (Hallandale Beach, Fl), announces today start of phase 1b clinical study of AV4025, an investigational, orally bioavailable HCV NS5A inhibitor, currently in clinical development for the treatment of chronic HCV infection.
In this randomized, double-blind, placebo-controlled, multi centre study of safety, tolerability, pharmacokinetics and antiviral activity of AV-4025 in HCV-infected patients, HCV- infected, treatmentnaive subjects will be randomized to receive 20 or 40 mg AV-4025 or placebo QD for 3 days (up to 10 subjects per cohort, drug:placebo ratio 4:1).
In a previous double-blind, placebo-controlled, single ascending oral dose study of AV4025 safety and tolerability in healthy volunteers, the drug was safe and well-tolerated. The pharmacokinetic analyses demonstrated high and dose-dependent drug exposure in plasma, and a long half-elimination time, supporting once daily dosing.
The final results of this 1b study of safety, tolerability, pharmacokinetics and antiviral activity of AV-4025 will be presented in at a major scientific conference in second half of this year.
Contact:
Alena Ivachtchenko, MBA
Director, Business Development
tel:1-786-617-4449
email: alena.ivachtchenko@allachem.com
www.allachem.com
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