A Single/Multiple Ascending Dose Phase 1 Study Of The Safety, Tolerability, And Pharmacokinetics Of Intranasal 2-Deoxy-D-Glucose In Normal Healthy Volunteers

Status: Completed
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: t
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• 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)

Locations
Other Locations
Austria
Medical University of Vienna
Vienna
Time Frame
Start Date: 2022-03-03
Completion Date: 2023-09-27
Participants
Target number of participants: 45
Treatments
Active_comparator: 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.
Placebo_comparator: 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.
Authors
Nadja Haiden
Related Therapeutic Areas
Common Cold
Sponsors
Leads: G.ST Antivirals GmbH

This content was sourced from clinicaltrials.gov

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