October 7 , 2013 I AllaChem, LLC, announced today a successful completion of phase 1a clinical study with AV4025, a proprietary orally-bioavailable small molecule that blocks HCV genome replication by targeting viral non-structural protein NS5A. In a double-blind, placebo-controlled, single ascending oral dose study of AV4025 safety and tolerability in healthy volunteers, each dose cohort (10 subjects per cohort) received a single dose of 10, 20, or 40 mg AV54025, or placebo (drug:placebo ratio 4:1). The drug was safe and well-tolerated, no serious adverse effects were reported. The pharmacokinetic analyses demonstrated high and dose-dependent drug exposure in plasma, and a long half-elimination time, supporting once daily dosing.
Dr. Vadim Bichko, AllaChem’s Scientific Advisor, had presented the preliminary results of the study at the 10th conference “Viral Hepatitis: Epidemiology, Diagnostics, Treatment and Prophylaxis”, Moscow, September 17-19, 2013.
Prof. Alexander Ivachtchenko, AllaChem’s CEO, stated, “We are very pleased with the safety and pharmacokinetic profiles of AV4025 in this first-in-man study. Further clinical development of the drug is warranted. We plan to begin next clinical study with AV4025 in the HCV patients in Q1 2014.”
SOURCE: AllaChem
Post Views: 128
October 7 , 2013 I AllaChem, LLC, announced today a successful completion of phase 1a clinical study with AV4025, a proprietary orally-bioavailable small molecule that blocks HCV genome replication by targeting viral non-structural protein NS5A. In a double-blind, placebo-controlled, single ascending oral dose study of AV4025 safety and tolerability in healthy volunteers, each dose cohort (10 subjects per cohort) received a single dose of 10, 20, or 40 mg AV54025, or placebo (drug:placebo ratio 4:1). The drug was safe and well-tolerated, no serious adverse effects were reported. The pharmacokinetic analyses demonstrated high and dose-dependent drug exposure in plasma, and a long half-elimination time, supporting once daily dosing.
Dr. Vadim Bichko, AllaChem’s Scientific Advisor, had presented the preliminary results of the study at the 10th conference “Viral Hepatitis: Epidemiology, Diagnostics, Treatment and Prophylaxis”, Moscow, September 17-19, 2013.
Prof. Alexander Ivachtchenko, AllaChem’s CEO, stated, “We are very pleased with the safety and pharmacokinetic profiles of AV4025 in this first-in-man study. Further clinical development of the drug is warranted. We plan to begin next clinical study with AV4025 in the HCV patients in Q1 2014.”
SOURCE: AllaChem
Post Views: 128
