Centre for Human Drug Research | Leiden, Netherlands
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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.
Full description
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.
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Interventional model
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128 participants in 2 patient groups, including a placebo group
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Central trial contact
Ingrid de Visser-Kamerling, PhD
Data sourced from clinicaltrials.gov
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