AVI BIOPHARMA REPORTS DATA FROM HCV DRUG TRIAL
AVI BioPharma has reported favorable safety and pharmacokinetic results from a Phase I clinical trial for chronic active hepatitis C virus (HCV). The multicenter study is designed to assess the safety, tolerability, pharmacokinetics and viral response to daily subcutaneous administration of its proprietary Neugene antisense compound AVI-4065 among healthy volunteers and patients with HCV.
The study enrolled and evaluated approximately 30 healthy volunteers at three dosage levels of AVI-4065. Trial participants received 50 mg, 100 mg or 300 mg of the drug by subcutaneous injection daily for 14 days, with each dose level evaluated for safety and tolerability, and a PK analysis conducted. No serious drug-related adverse events occurred at any dosage level. All dosages were well-tolerated with no injection site reactions or events that required intervention