Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-25 @ 4:10 AM
NCT ID:
NCT02807220
Eligibility Criteria:
Inclusion Criteria:
* physically and mentally healthy as judged by means of a medical and laboratory standard
* the outcome of the following examinations should be clinically insignificant: medical and surgical history (hypo-, hypertension, allergy, other diseases, major surgery, micturition, defecation, sleep, illness within the last 4 weeks prior to the start of the trial)
* life style and habits (consumption of alcohol, nicotine, coffee, tea, coke, special diet, drug abuse) should be normal/acceptable
* body temperature, pulse rate, blood pressure, 12 lead ECG should be normal/acceptable.
* physical examination (general state and abnormal findings per system: endocrine/metabolic, allergies, drug sensitivities, head, neck, eyes, ears, nose, throat, cardiovascular, respiratory, gastrointestinal, hepatic/biliary, urogenital, musculoskeletal, Iymph nodes, skin, and neurological/psychiatric) should be normal/acceptable
* laboratory examination (blood/serum examination: sodium, potassium, calcium, chloride, total protein, glucose, creatinine, BUN, uric acid, total bilirubin, AST, ALT, GGT, ALP, haemoglobin, haematocrit, erythrocytes, Ieukocytes, platelet count; HBsAg, HIV-Ab, HCV-Ab; urine examination: urine pH, protein, glucose, ketones, blood, Ieukocytes, bilirubin, nitrites and sediment) should be normal/acceptable.
* normal body weight in relation to height and age according to weight(kg) BMI = (accepted range 18.5 and30 kg/m2) height (m)2
* subjects must be competent to sign and have signed a consent form before study entry
Exclusion Criteria:
* acute or chronic upper airways disease, chronic cough, chronic rhinitis (e.g. allergic rhinitis) or asthma,
* vaccination against influenza or swine flu
* within 21 days before the study start, suspected swine flu or influenza, body temperature 38 0C,
* pregnancy or nursing,
* use of immunosuppressant, stimulants or common cold therapeutics,
* bacterial tonsillitis,
* allergic diathesis or any clinically significant allergic disease (i.e. asthma)
* any history of drug hypersensitivity (especially to β-glucan and related compounds)
* presence or a history of clinically significant cardiovascular, renal, hepatic, pulmonary, metabolic, endocrine, haematological, gastrointestinal, neurological, psychiatric or other major diseases
* clinically significant illness within 4 weeks before the start of the study
* intake or administration of any prescribed systemic or topical medication within 2 weeks prior to the start of the study; in the case of intake or administration of any prescribed systemic or topical medication within 4 weeks before the start of the study because of an insignificant illness, this should be stated in the CRF.
* intake or administration of OTC medication (including herbal remedies) within 1 week prior to the start of the study
* concomitant intake or administration of any systemic or topical drugs (including herbal remedies)
* treatment with any investigational drug (i.e., drug not yet approved) in the last 2 months (60 days) before beginning of the trial
* medication with drugs known to alter organs or systems such as barbiturates, phenothiazines, cimetidine, omeprazole etc. within the last 2 months (60 days)
* major surgery of the gastrointestinal tract except for appendectomy
* supine blood pressure, after resting for 5 min, higher than 140/90 or lower than 100/60 mmHg
* supine pulse rate, after resting for 5 min, outside the range of 50 - 90 beats/min
* any clinically significant abnormality of the ECG (12 leads) recorded in rest
* laboratory values outside the normal range (Appendix 5) with clinical relevance at entry examination
* alcohol abuse i.e. regular use of more than 2 units of alcohol per day or a history of alcoholism or drug/chemical abuse (one unit of alcohol equals ½ l of beer, 200 ml wine or 50 ml of spirits) or recovered alcoholics
* vegetarian or any special diet due to any reason
* knowledge to have any type of parenterally transmitted hepatitis or carrier of the HBsAg (HBsAg test positive)
* HIV-Ab test positive
* Test on anti-HCV antibodies positive
* legal incapacity and/or other circumstances rendering the subject unable to understand the nature, scope and possible consequences of the study
* evidence of an uncooperative attitude
* \> 10 % non-compliance to the investigational product.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02807220
Study Brief:
Protocol Section:
NCT02807220