A Phase 1 interventional study of 2-Deoxyglucose and Placebo in Acute Nasopharyngitis, sponsored by G.ST Antivirals GmbH. Completed at 1 site in Austria. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-12.
Sponsored by G.ST Antivirals GmbH · Phase 1, Interventional, and Prevention
2-DG-01 is a randomized, double-blind, placebo-controlled, single and multiple ascending dose phase 1 study assessing safety, tolerability and pharmacokinetics of 2-DG in normal healthy volunteers (NHV). The safety and pharmacokinetics of 2-DG are assessed after single or multiple intranasal administrations.
2-DG-01 is a randomized, placebo-controlled, double- blind single and multiple ascending dose phase 1 study in normal healthy male and female volunteers aged 18 years or older.
The primary objective of this study is to assess the clinical safety and tolerability of intranasal 2-DG in NHVs.
The secondary objective of this study is to assess the human pharmacokinetics of 2-DG.
The study is divided in two sub-parts: Part A, a single ascending dose (SAD) study of 2-DG and Part B, a multiple ascending dose (MAD) study.
Part A consists of 3 cohorts: Cohorts 1 and 2 with a randomization ratio for 2-DG to placebo of 4:1 and Cohort 3 with a randomization ratio for 2-DG to placebo of 8:2.
Part B consists of 3 cohorts: Cohort 4 with a a randomization ratio for 2-DG to placebo of 4:1 and Cohorts 5 and 6 with a randomization ratio for 2-DG to placebo of 8:2.
Cohorts 1, 2 and 4 will also be controlled by randomized intranasal application of placebo into the opposite nostril to obtain an intra-individual estimate for local tolerability. Other cohorts will receive either 2-DG or placebo into both nostrils.
Interim safety reviews are performed by a Data Monitoring Committee.
219 studies on the registry are indexed under Common Cold; 23 are open to participants now.
This study's enrollment of 45 is below the median of 150 across 184 interventional studies indexed under Common Cold.
Browse Common Cold studies →G.ST Antivirals GmbH is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Each subject receives either a single dose (SAD) or a multiple dose (MAD) of a 3.5% 2-Deoxyglucose as nasal spray solution. The starting dose for the first cohort is 3.5 mg/day up to a maximum of 84 mg/day at cohort 6.
Drug: 2-Deoxyglucose
Each subject receives either a single (SAD) or multiple (MAD) dose of placebo. The dose for each cohort is corresponding the amount of solution needed in the verum group.
Other: Placebo
Intranasal administration
Also known as: 2-DG, 2-Deoxy-D-glucose
Intranasal administration
Adverse drug reactions (ADRs)
Number of ADRs after a single dose of 2-DG assessed by type, frequency and severity of ADRs graded as per Common Terminology Criteria for Adverse Events (CTCAE).
Time frame: until 24 hours after single drug dosing
Adverse drug reactions (ADRs)
Number of ADRs after multiple doses of 2-DG assessed by type, frequency and severity of ADRs graded as per Common Terminology Criteria for Adverse Events (CTCAE).
Time frame: until 168 hours after start of multiple drug dosing
Biodistribution of a single dose of 2-DG
Analysis of 2-DG concentrations in plasma and nasal wash samples measured by LC-MS (µg/ml).
Time frame: baseline,0.5 hours, 2 hours, 4 hours, 6 hours after single drug dosing
Biodistribution of multiple doses of 2-DG
Analysis of 2-DG concentrations in plasma and nasal wash samples measured by LC-MS (µg/ml).
Time frame: baseline, 12 hours, 15 hours, 24 hours, 72 hours, 168 hours after start of multiple drug dosing
Local tolerability of a single dose of 2-DG
Abnormal physical examination findings in the nasal cavity (type, frequency, severity of medical abnormalities, scoring of self-reported symptoms).
Time frame: baseline, 6 hours, 24 hours after single drug dosing
Local tolerability of multiple doses of 2-DG
Abnormal physical examination findings in the nasal cavity (type, frequency, severity of medical abnormalities, scoring of self-reported symptoms).
Time frame: baseline, 3 hours, 12 hours, 24 hours after start of multiple drug dosing
Olfactory function after a single dose of 2-DG
Change in olfactory capacity using sniffing sticks measured by Threshold-Discrimination-Identification score (TDI score). Minimum value = 0 , maximum value= 48. A higher score means a better outcome.
Time frame: baseline, 24 hours after single drug dosing
Olfactory function after multiple doses of 2-DG
Change in olfactory capacity using sniffing sticks measured by Threshold-Discrimination-Identification score (TDI score). Minimum value = 0 , maximum value= 48. A higher score means a better outcome.
Time frame: baseline, 24 hours, 72 hours, 168 hours after start of multiple drug dosing
Premature terminations due to ADRs after a single dose of 2-DG
Number of premature terminations due to ADRs that are assessed by type, frequency and severity graded as per Common Terminology Criteria for Adverse Events (CTCAE).
Time frame: until 24 hours after single drug dosing
Premature terminations due to ADRs after multiple doses of 2-DG
Number of premature terminations due to ADRs that are assessed by type, frequency and severity graded as per Common Terminology Criteria for Adverse Events (CTCAE).
Time frame: until 168 hours after start of multiple drug dosing
Adverse events after single dose 2-DG
Number of AEs assessed by type, frequency and severity graded as per Common Terminology Criteria for Adverse Events (CTCAE).
Time frame: until 24 hours after single drug dosing
Adverse events after multiple doses 2-DG
Number of AEs assessed by type, frequency and severity graded as per Common Terminology Criteria for Adverse Events (CTCAE).
Time frame: until 168 hours after start of multiple drug dosing
Plan to share: No
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Ran from Mar 2022 to primary completion in Aug 2023, 16 months.
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This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Deoxyglucose
G.ST Antivirals GmbH