Clinical trial NCT05314933: Safety and Pharmacokinetic Study of Intranasal 2-DG in Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Nasopharyngitis
Keywords: Virus disease
Respiratory infection
Common cold virus
Rhinovirus
Lead sponsor: G.ST Antivirals GmbH
Sponsor class: INDUSTRY
First posted: 2022-04-07
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adverse drug reactions (ADRs)
timeFrame: until 24 hours after single drug dosing
measure: Adverse drug reactions (ADRs)
timeFrame: until 168 hours after start of multiple drug dosing
Secondary outcomes:
measure: Biodistribution of a single dose of 2-DG
timeFrame: baseline,0.5 hours, 2 hours, 4 hours, 6 hours after single drug dosing
measure: Biodistribution of multiple doses of 2-DG
timeFrame: baseline, 12 hours, 15 hours, 24 hours, 72 hours, 168 hours after start of multiple drug dosing
measure: Local tolerability of a single dose of 2-DG
timeFrame: baseline, 6 hours, 24 hours after single drug dosing
measure: Local tolerability of multiple doses of 2-DG
timeFrame: baseline, 3 hours, 12 hours, 24 hours after start of multiple drug dosing
measure: Olfactory function after a single dose of 2-DG
timeFrame: baseline, 24 hours after single drug dosing
measure: Olfactory function after multiple doses of 2-DG
timeFrame: baseline, 24 hours, 72 hours, 168 hours after start of multiple drug dosing
measure: Premature terminations due to ADRs after a single dose of 2-DG
timeFrame: until 24 hours after single drug dosing
measure: Premature terminations due to ADRs after multiple doses of 2-DG
timeFrame: until 168 hours after start of multiple drug dosing
measure: Adverse events after single dose 2-DG
timeFrame: until 24 hours after single drug dosing
measure: Adverse events after multiple doses 2-DG
timeFrame: until 168 hours after start of multiple drug dosing
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References: