The study is being conducted by PhaseOneTrials, Copenhagen, and will include a maximum of 48 healthy male volunteers. The company has also announced that the first cohort of healthy volunteers in the study have completed treatment satisfactorily.
The Phase I clinical trial is a placebo-controlled, double-blind, randomized, single dose, dose-escalating safety study of SPC3649 in a total of 48 healthy male volunteers. The volunteers are divided into six groups with eight persons in each. In each group six persons will receive SPC3649 and two will receive placebo (non-effective substance). Each volunteer will receive a single two hour intravenously infusion with either SPC3649 or placebo. SPC3649 will be administered at six escalating dose levels and each volunteer will be followed for three months.
SPC3649 is being developed by Santaris Pharma as a potential new approach to the treatment for hepatitis C infection. SPC3649 specifically targets microRNA-122, a small, liver-expressed, regulatory ribonucleic acid that has recently been shown to facilitate human hepatitis C virus replication in liver cells.
Keith McCullagh, president and CEO of Santaris Pharma, said: “The mechanism of action of this drug represents a potential breakthrough in medical science. The ability to switch off the functions of particular microRNAs may enable clinicians to modulate entire networks of genes associated with disease or ill-health.”