The trial has been launched in the US to determine the safety, tolerability, and pharmacokinetics of the drug in healthy adult volunteers.
The inhaled formulation of ALN-RSV01 used in this phase I study is a nebulized formulation, and advances previous clinical work for ALN-RSV01 administered as an intranasal spray. ALN-RSV01 is an RNAi therapeutic in clinical development for the treatment of respiratory syncytial virus (RSV) infection.
This newly initiated phase I trial with inhaled ALN-RSV01 uses a formulation that is designed to deliver the RNAi therapeutic to the lungs, and is the expected formulation for the treatment of RSV in naturally infected patients. Models of this aerosolized formulation of ALN-RSV01 predict that it can be delivered to the alveoli and the small airways of the infant and adult human lung.
Alnylam previously completed two phase I human clinical trials of ALN-RSV01 using an intranasal formulation. The previous studies demonstrated that ALN-RSV01 was safe and well tolerated when administered intranasally in relevant doses to human volunteers and had a profile comparable to placebo.
Later this year, the company expects to initiate an experimental infection, or “viral challenge,” study with the intranasal formulation of ALN-RSV01 in healthy adult volunteers.