Alnylam Pharmaceuticals has initiated a Phase I study in Europe to evaluate the human safety and pharmacology of ALN-RSV01, an RNAi therapeutic, in healthy volunteers.
Alnylam will be conducting two Phase I trials with ALN-RSV01. The first trial is expected to enroll 57 healthy adult male volunteers. Drug or placebo will be administered intranasally in both single ascending doses across three cohorts and in multiple ascending doses daily for five consecutive days across three cohorts. The second trial, which is expected to initiate dosing by the end of the month, will be conducted in the U.S. and is expected to enroll 35 healthy adult male volunteers. Drug or placebo will be administered intranasally in single ascending doses across five cohorts. In both studies, ALN-RSV01 will be evaluated for safety, tolerability, and pharmacokinetics.