Acute NasopharyngitisPhase 1NCT05314933
Safety and Pharmacokinetic Study of Intranasal 2-DG in Healthy Volunteers
A Phase 1 study testing 2-Deoxyglucose in people with Acute Nasopharyngitis, run by G.ST Antivirals GmbH at 1 site in Austria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Nasopharyngitis
- What is being tested?
- 2-Deoxyglucose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteAustria
- Study dates
- 3 Mar 2022to 27 Sep 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female volunteers, age ≥ 18 years old at screening
- Females must be post-menopausal (> 1 year since last menstruation)
- Able to comprehend and to give informed consent
- Able to cooperate with the investigator, to comply with the requirements of the study, and to complete the full sequence of protocol-related procedures
- Undergone full immunisation against SARS-CoV2 or status post infection with SARS-CoV2 (both as defined by the Austrian Ministry of Health)
Who cannot join
- Frequent epistaxis (equal to or greater than 1/month)
- Hypo- or anosmia
- Symptoms of rhinitis, allergy or common cold disease at screening and at study initiation
- Medical history of diabetes mellitus of any type
- Clinically relevant abnormal findings at screening
- Preceding nasal surgery or sinus surgery
Show all 14Show fewer
- Medical history of allergic rhinitis or chronic condition of the upper or lower respiratory tract with active symptoms within 30 days prior to screening
- SARS-CoV-2 infection positive by PCR test at screening
- Vulnerable subjects as defined by GCP
- Subjects in a dependency relationship towards the investigators, e.g. as employees
- Substance abuse, mental illness, or any reason that makes it unlikely in the judgment of the investigator for the subject to be able to comply fully with study procedures
- Use of medication (including prophylactic treatments) during 2 weeks before the start of the study, which in the judgment of the investigator may adversely affect the subject's welfare or the integrity of the study's results
- Concurrent treatment with other experimental product or participation in another clinical trial with any investigational product within 30 days or 5 elimination half-lives (whichever is longer) prior to treatment start
- Scheduled vaccination appointments during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single/Multiple Ascending Dose Phase 1 Study Of The Safety, Tolerability, And Pharmacokinetics Of Intranasal 2-Deoxy-D-Glucose In Normal Healthy Volunteers
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.
Read the detailed description
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.
- Conditions
- Acute Nasopharyngitis
- Being tested
- 2-Deoxyglucose, Placebo
- Keywords
- Virus disease, Respiratory infection, Common cold virus, Rhinovirus
- Medical subject headings
- Common Cold, Virus Diseases, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-DeoxyglucoseDrug
Also called 2-DG, 2-Deoxy-D-glucose
Intranasal administration
PlaceboOther
Intranasal administration
| Study group | Role | What they receive |
|---|---|---|
| Study drug | Active comparator | 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. Receives: Drug: 2-Deoxyglucose |
| Placebo | Placebo comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: until 168 hours after start of multiple drug dosing
Secondary outcomes (10)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: until 168 hours after start of multiple drug dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start3 Mar 2022
- Primary completion1 Aug 2023
- Study completion27 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute NasopharyngitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- G.ST Antivirals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314933
- Sponsor's protocol ID
- 2-DG-01
- Status last verified
- Oct 2023
- First submitted
- 3 Feb 2022
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bischof T, Gsoellpointner M, Miljevic KDK, Moser MM, Dizdarevic AM, Gualdoni GA, Gorki AD, Nicolodi C, Chou S, Radivojev S, Haiden N, Mueller CA, Firbas C, Jilma B, Schoergenhofer C. Safety, tolerability, and pharmacokinetics of intranasal 2-deoxy-D-glucose in normal healthy volunteers: A randomized, double-blind, placebo-controlled, single and multiple ascending dose phase 1 study. Eur J Pharm Sci. 2025 Jun 1;209:107069. doi: 10.1016/j.ejps.2025.107069. Epub 2025 Mar 16.
PubMed 40101848
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single/Multiple Ascending Dose Phase 1 Study Of The Safety, Tolerability, And Pharmacokinetics Of Intranasal 2-Deoxy-D-Glucose In Normal Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05314933
- Acronym / sponsor ID
- 2-DG-01
- Conditions
- Acute Nasopharyngitis
- Keywords
- Virus disease, Respiratory infection, Common cold virus, Rhinovirus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- G.ST Antivirals GmbHIndustry (pharma, biotech, devices)
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 27 Sep 2023 (actual)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study drug | Active comparator | Drug: 2-DeoxyglucoseEach 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. |
| Placebo | Placebo comparator | Other: PlaceboEach 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy male or female volunteers, age ≥ 18 years old at screening
- Females must be post-menopausal (> 1 year since last menstruation)
- Able to comprehend and to give informed consent
- Able to cooperate with the investigator, to comply with the requirements of the study, and to complete the full sequence of protocol-related procedures
- Undergone full immunisation against SARS-CoV2 or status post infection with SARS-CoV2 (both as defined by the Austrian Ministry of Health)
Key exclusion criteria (14 listed)
- Frequent epistaxis (equal to or greater than 1/month)
- Hypo- or anosmia
- Symptoms of rhinitis, allergy or common cold disease at screening and at study initiation
- Medical history of diabetes mellitus of any type
- Clinically relevant abnormal findings at screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2-DeoxyglucoseAlso: 2-DG, 2-Deoxy-D-glucoseIntranasal administration | Drug | Study drug |
| PlaceboIntranasal administration | Other | Placebo |
Primary outcome
Adverse drug reactions (ADRs)
Time frame: until 24 hours after single drug dosing
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).
Adverse drug reactions (ADRs)
Time frame: until 168 hours after start of multiple drug dosing
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).
10 secondary outcomes
Biodistribution of a single dose of 2-DG
Time frame: baseline,0.5 hours, 2 hours, 4 hours, 6 hours after single drug dosing
Biodistribution of multiple doses of 2-DG
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
Time frame: baseline, 6 hours, 24 hours after single drug dosing
Local tolerability of multiple doses of 2-DG
Time frame: baseline, 3 hours, 12 hours, 24 hours after start of multiple drug dosing
Olfactory function after a single dose of 2-DG
Time frame: baseline, 24 hours after single drug dosing
Olfactory function after multiple doses of 2-DG
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
Time frame: until 24 hours after single drug dosing
Premature terminations due to ADRs after multiple doses of 2-DG
Time frame: until 168 hours after start of multiple drug dosing
Adverse events after single dose 2-DG
Time frame: until 24 hours after single drug dosing
Adverse events after multiple doses 2-DG
Time frame: until 168 hours after start of multiple drug dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- Derived from this study: PubMed 40101848Bischof T, Gsoellpointner M, Miljevic KDK, Moser MM, Dizdarevic AM, Gualdoni GA, Gorki AD, Nicolodi C, Chou S, Radivojev S, Haiden N, Mueller CA, Firbas C, Jilma B, Schoergenhofer C. Safety, tolerability, and pharmacokinetics of intranasal 2-deoxy-D-glucose in normal healthy volunteers: A randomized, double-blind, placebo-controlled, single and multiple ascending dose phase 1 study. Eur J Pharm Sci. 2025 Jun 1;209:107069. doi: 10.1016/j.ejps.2025.107069. Epub 2025 Mar 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 2-Deoxyglucose in people with Acute Nasopharyngitis, run by G.ST Antivirals GmbH at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse drug reactions (ADRs) (time frame: until 24 hours after single drug dosing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05314933, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023.