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

• Status: Recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: G.ST Antivirals GmbH
• Treatments: Deoxyglucose

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

• 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