Arrowhead sought MEDSAFE for ARO-HBV study

Arrowhead Pharmaceuticals sought approval from the New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE) and from the local Ethics Committee to proceed with a first-in-human study of ARO-HBV.

The study, ARO-HBV study 1001 (NCT03365947), is a Phase 1/2 study to evaluate the safety, tolerability, and pharmacokinetic effects of single-ascending doses (SAD) of ARO-HBV in healthy adult volunteers, and to evaluate the safety, tolerability, and pharmacodynamic effects of multiple-ascending doses (MAD) of ARO-HBV in patients with chronic HBV.

The SAD portion is designed to include up to 5 cohorts of 6 subjects per cohort. Each SAD subject will receive a single-dose administration of either placebo or ARO-HBV at up to 5 dose levels (35, 100, 200, 300, 400 mg). The MAD portion is designed to include up to 8 cohorts of 4 HBV patients per cohort. Each MAD patient will receive 3 doses of ARO-HBV at up to 4 dose levels (100, 200, 300, 400 mg).