Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06375772
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-08
Brief Title:
A Controlled Human Rhinovirus Infection Study of 2-Deoxy-D-Glucose in Healthy Adults
Sponsor:
GST Antivirals GmbH
Organization:
GST Antivirals GmbH
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed 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 11 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
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 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None