A phase I, open label clinical trial in healthy volunteers, to assess and characterize the effect of FIRTECH infrared patch on tissue perfusion, oxygenation and local microcirculation.

1. Signed informed consent prior to any study-mandated procedure
2. Healthy male or female subjects, 18 to 55 years of age, inclusive.
3. Body mass index (BMI) between 18 and 30 kg/m2, inclusive at screening, and
with a minimum weight of 50 kg.
4. Has the ability to communicate well with the Investigator in the Dutch
language and willing to comply with the study restrictions.

1. Evidence of any active or chronic disease or condition that could interfere
with, or for which the treatment of might interfere with, the conduct of the
study, or that would pose an unacceptable risk to the subject in the opinion of
the investigator (following a detailed medical history, physical examination,
vital signs (systolic and diastolic blood pressure, pulse rate, body
temperature) and12-lead electrocardiogram (ECG)). Minor deviations from the
normal range may be accepted, if judged by the Investigator to have no clinical
relevance.
2. Clinically significant abnormalities, as judged by the investigator, in
laboratory test results (including hepatic and renal panels, complete blood
count, chemistry panel and urinalysis). In the case of uncertain or
questionable results, tests performed during screening may be repeated before
patch side location randomization to confirm eligibility or judged to be
clinically irrelevant for healthy subjects.
3. Systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, and
diastolic blood pressure (DBP) greater than 90 or less than 50 mm Hg at
screening.
4. Use of any medications (prescription or over the counter [OTC]), within 14
days of study product administration, or less than 5 half-lives (whichever is
longer). Exceptions are paracetamol (up to 4 g/day) and ibuprofen (up to
1g/day). Other exceptions will only be made if the rationale is clearly
documented by the investigator.
5. Use of any vitamin, mineral, herbal, and dietary supplements within 7 days
of study product administration, or less than 5 half-lives (whichever is
longer). Exceptions will only be made if the rationale is clearly documented by
the investigator.
6. Participation in an investigational drug or device study (last dosing of
previous study was within 30 days prior to first dosing of this study).
7. History of abuse of addictive substances (alcohol, illegal substances) or
current use of more than 21 units alcohol per week, drug abuse, or regular user
of sedatives, hypnotics, tranquillizers, or any other addictive agent
8. Positive test for drugs of abuse at screening.
9. Alcohol will not be allowed from at least 24 hours before screening.
10. Active smoker (i.e. on average >3 cigarettes per day in the last 3 months)
11. Excess of caffeine consumption (more than eight cups of coffee or
equivalent per day)
12. Any confirmed significant allergic reactions (urticaria or anaphylaxis)
against any drug, or multiple drug allergies (non-active hay fever is
acceptable).
13. Loss or donation of blood over 500 mL within three months (males) or four
months (females) prior to screening or intention to donate blood or blood
products during the study.
14. If a woman, pregnant, or breast-feeding, or planning to become pregnant
during the study.
15. Any known factor, condition, or disease that might interfere with treatment
compliance, study conduct or interpretation of the results such as drug or
alcohol dependence or psychiatric disease.
16. Any tattoos, body modifications or other impediments to imaging present in
areas to be assessed, i.e. right and left arm and back.