Pilot Study on the Efficacy of Pascoflair in an Acute Stressful Situation (TSST)

Inclusion Criteria

• Provide written informed consent;
• Healthy male and female subjects
• Non-smoker;
• Age 25 to 45 years;
• BMI ≥ 19 to ≤ 30 kg/m2

Exclusion Criteria

• Any known allergies to the test substance;
• Any known addiction to drugs, alcohol or positive results in the drug screening test;
• Any serious general illness, ongoing or within the last 12 months;
• Any febrile illness (> 24 hrs.) within 7 days prior to treatment;
• Any antibiotics for the last four weeks before study inclusion;
• Diabetes mellitus;
• Known heart disease, hypertension, kidney disease, significant respiratory disease, epilepsy, or rheumatoid arthritis;
• Known immunologic or infectious disease (e.g. hepatitis, tuberculosis, HIV or AIDS) which could place the subject at risk or interfere with the accuracy of the study results;
• Pregnancy or lactating;
• Current participation or participation in any type of clinical study in the past week;
• Current or past participation in a TSST study;
• Employees of the Sponsor or the CRO;
• Any other medication that, in the opinion of the Investigator is likely to affect their response to treatment;
• Clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, or haematology as judged by the Investigator;
• Any other condition the Investigator or their duly assigned representatives believes may affect the ability of the individual to complete the study or the interpretation of the study results.