The objectives of the studies were to investigate the intravenous and subcutaneous safety assessment of rHuPH20 administered at significantly higher doses to non-human primates than previously examined. The use of rHuPH20 at higher concentrations in formulations may potentially facilitate the conversion from IV to SC administration of therapeutic proteins by allowing increased injection volumes and local dispersion and absorption of SC co-injected therapeutic proteins into the systemic circulation.
The company has said that in a pharmacokinetic dose-range finding study, doses up to 3,600,000U/kg (30mg/kg) were well-tolerated following either IV or SC dosing. Daily administration of rHuPH20 for one week was well tolerated via either IV or SC delivery at a daily bolus dose of 600,000U/kg (5mg/kg). No test article-related changes were observed in any toxicology parameters and no systemic enzyme accumulation was observed.