Acute Nasopharyngitis Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled Phase 2 Study Using the Rhinovirus Challenge Model to Investigate the Efficacy and Safety of 2-Deoxy-D-Glucose as Pre-exposure Prophylaxis
2-DG-02 is a randomized, placebo-controlled, double-blind Phase 2 study to investigate the efficacy and safety of 2-Deoxy-D-Glucose as a pre-exposure prophylaxis using the rhinovirus challenge model in healthy study participants.
2-DG-02 is a randomized, placebo-controlled, double-blind Phase 2 study using the rhinovirus challenge model in healthy study participants aged 18 to 64 years. The primary objective is to confirm the efficacy of 2-DG compared to placebo for the prevention of rhinovirus-associated illness. Secondary objectives are - to evaluate the effect of 2-DG on the occurrence and course of rhinovirus infection - to evaluate the effect of 2-DG on the severity of symptoms of rhinovirus infection - to evaluate safety and tolerability of 2-DG administrated over 1 week in the presence of rhinovirus exposure - to evaluate pharmacokinetics of 2-DG 128 subjects, who have been pre-screened and found to be seronegative to rhinovirus type 39, are randomized 1:1 to either 2-DG (pre-exposure prophylaxis) or placebo the day prior to inoculation. Subjects receive 2-DG or placebo starting from the day prior to inoculation until 5 days post inoculation. Interim safety and efficacy reviews are performed by a Safety Monitoring Committee. ;