Acute Nasopharyngitis
Conditions
Keywords
Virus disease, Respiratory infection, Common cold virus, Rhinovirus
Brief 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.
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.
Interventions
DRUG2-Deoxyglucose
Intranasal administration
OTHERPlacebo
Intranasal administration
Sponsors
G.ST Antivirals GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* 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)
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse drug reactions (ADRs) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biodistribution of multiple doses of 2-DG | baseline, 12 hours, 15 hours, 24 hours, 72 hours, 168 hours after start of multiple drug dosing | Analysis of 2-DG concentrations in plasma and nasal wash samples measured by LC-MS (µg/ml). |
| Local tolerability of a single dose of 2-DG | baseline, 6 hours, 24 hours after single drug dosing | Abnormal physical examination findings in the nasal cavity (type, frequency, severity of medical abnormalities, scoring of self-reported symptoms). |
| Local tolerability of multiple doses of 2-DG | baseline, 3 hours, 12 hours, 24 hours after start of multiple drug dosing | Abnormal physical examination findings in the nasal cavity (type, frequency, severity of medical abnormalities, scoring of self-reported symptoms). |
| Olfactory function after a single dose of 2-DG | baseline, 24 hours after single drug dosing | 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. |
| Biodistribution of a single dose of 2-DG | baseline,0.5 hours, 2 hours, 4 hours, 6 hours after single drug dosing | Analysis of 2-DG concentrations in plasma and nasal wash samples measured by LC-MS (µg/ml). |
| Premature terminations due to ADRs after a single dose of 2-DG | until 24 hours after single drug dosing | 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). |
| Premature terminations due to ADRs after multiple doses of 2-DG | until 168 hours after start of multiple drug dosing | 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). |
| Adverse events after single dose 2-DG | until 24 hours after single drug dosing | Number of AEs assessed by type, frequency and severity graded as per Common Terminology Criteria for Adverse Events (CTCAE). |
| Adverse events after multiple doses 2-DG | until 168 hours after start of multiple drug dosing | Number of AEs assessed by type, frequency and severity graded as per Common Terminology Criteria for Adverse Events (CTCAE). |
| Olfactory function after multiple doses of 2-DG | baseline, 24 hours, 72 hours, 168 hours after start of multiple drug dosing | 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. |
Countries
Austria
Outcome results
None listed