News from Hepatitis Week of May 4, 2003 / Vol. 3 No. 18

Study: Hepavir B in Phase 1 Clinical Trial in U.S. for Hepatitis B

Ribapharm Inc. has begun clinical testing of its drug candidate Hepavir B in patients with the hepatitis B virus.

The company announced May 1 that enrollment of patients would be ongoing as the trial progresses. Hepavir B is a nucleoside analog.

In August 2002, Ribapharm initiated a Phase 1 clinical trial of Hepavir B in Europe, and in October 2002 filed an Investigation New Drug application with the U.S. Food and Drug Administration to initiate Phase 1 clinical studies in the United States.

Phase 1 clinical trials usually involve between 20 and 80 healthy volunteers or patients and typically take one to two years to complete. Phase 1 tests a drug's safety profile, establish a safe dosage range and determine how a drug is absorbed, distributed, metabolized and excreted from the body.

Other sources: Ribapharm