Genetic Polymorphism, Healthy Subjects, Heme Oxygenase
Conditions
Brief summary
Heme oxygenase 1 (HO-1) serves as a protective gene. It has been shown that one factor modulating HO-1 activity is a genetic variation in the HO-1 gene (functional GT length polymorphism in the promotor region). Heme arginate is a strong inducer of HO-1 as shown in several animal experimental studies. The aim of this clinical trial is to evaluate the HO-1 stimulation of heme arginate in healthy humans.
Interventions
DRUGsaline solution
intravenous infusion, single dose
DRUGheme arginate
intravenous infusion, single dose 0.3 mg/kg heme arginate
Sponsors
Daniel Doberer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Signed informed consent prior to any study-mandated procedure. * Male aged between 18 and 45 years (inclusive) at screening. * No clinically significant findings on the physical examination at screening. * Body mass index (BMI) between 18 and 28 kg/m2 (inclusive) at screening. * 12-lead ECG without clinically relevant abnormalities at screening. * Hematology, clinical chemistry, and urinalysis test results not deviating from the normal range to a clinically relevant extent at screening. * Negative results from urine drug screen at screening. * Ability to communicate well with the investigator, in the local language, and to understand and comply with the requirements of the study.
Exclusion criteria
* Known hypersensitivity to the study drug or any excipients of the drug formulation. * Treatment with another investigational drug within 3 months prior to screening. * History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening. * History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drugs. * Smoking within the last 3 months prior to screening. * Previous treatment with any prescribed or OTC medications (including herbal medicines such as St John's Wort) within 2 weeks prior to screening. * Loss of 250 ml or more of blood within 3 months prior to screening. * Positive results from the hepatitis serology, except for vaccinated subjects, at screening. * Positive results from the HIV serology at screening. * Presumed non-compliance. * Legal incapacity or limited legal capacity at screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The maximal HO-1 mRNA expression in PBMCs | 2 months |
Countries
Austria
Outcome results
None listed