Status:
COMPLETED
Safety and Pharmacokinetic Study of Intranasal 2-DG in Healthy Volunteers
Lead Sponsor:
G.ST Antivirals GmbH
Conditions:
Acute Nasopharyngitis
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
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 (NH...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2023
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT05314933
Start Date
March 3 2022
End Date
September 27 2023
Last Update
October 12 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Medical University of Vienna
Vienna, Austria, 1090