Safety and Pharmacokinetic Study of Intranasal 2-DG in Healthy Volunteers

NCT05314933 | Completed Phase 1 DMC

• 1 other identifier: 2-DG-01
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Nasopharyngitis

Keywords

Virus disease; Respiratory infection; Common cold virus; Rhinovirus

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  until 168 hours after start of multiple drug dosing

Secondary Outcomes (10)

• Biodistribution of a single dose of 2-DG

  baseline,0.5 hours, 2 hours, 4 hours, 6 hours after single drug dosing

• Biodistribution of multiple doses of 2-DG

  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

  baseline, 6 hours, 24 hours after single drug dosing

• Local tolerability of multiple doses of 2-DG

  baseline, 3 hours, 12 hours, 24 hours after start of multiple drug dosing

• Olfactory function after a single dose of 2-DG

  baseline, 24 hours after single drug dosing

Study Arms (2)

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.

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.

Other: Placebo

Interventions

2-Deoxyglucose DRUG

Intranasal administration

Also known as: 2-DG, 2-Deoxy-D-glucose

Study drug

Placebo OTHER

Intranasal administration

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• G.ST Antivirals GmbH: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (1)

• 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.

  PMID: 40101848 DERIVED

MeSH Terms

Conditions

Common Cold; Virus Diseases; Respiratory Tract Infections

Interventions

Deoxyglucose

Condition Hierarchy (Ancestors)

Infections; Picornaviridae Infections; RNA Virus Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Deoxy Sugars; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: April 7, 2022
• Study Start: March 3, 2022
• Primary Completion: August 1, 2023
• Study Completion: September 27, 2023
• Last Updated: October 12, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)