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

NCT ID: NCT05314933

Last Updated: 2023-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-03
• Study Completion Date: 2023-09-27

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.

Conditions

Acute Nasopharyngitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Study drug

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.

Group Type: ACTIVE_COMPARATOR

2-Deoxyglucose

Intervention Type: DRUG

Intranasal administration

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Intranasal administration

Interventions

2-Deoxyglucose

Intranasal administration

Intervention Type: DRUG

Placebo

Intranasal administration

Intervention Type: OTHER

Other Intervention Names

2-DG; 2-Deoxy-D-glucose

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

G.ST Antivirals GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical University of Vienna

Vienna, , Austria

Countries

Austria

References

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.

Reference Type: DERIVED

PMID: 40101848 (View on PubMed)

Other Identifiers

2-DG-01

Identifier Type: -

Identifier Source: org_study_id