Healthy Individual
Conditions
Interventions
Evauation of the safety of 20g of transgenic rice containing peptides from Japanese cedar pollen allergens.
Evauation of the safety of 40g of transgenic rice containing peptides from Japanese cedar po
Sponsors
Department of Molecular Immunology, Institute of DNA Medicine, The Jikei University, School of Medicine.
National Institute of Agrobiological Sciences (NIAS) SATAKE Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy Adult aged between 20yo and 65yo. 2) A person aged over 20yo, and can voluntary enroll as a subject for the clinical research.
Exclusion criteria
Exclusion criteria: 1) A person with a BMI values under 17, or over 28. 2) A person who has hay fever and/or medical history of other allergic disorder. 3) Preliminarily examined positive at more than one of followings; Rhinoscopic examination, Nasal mucosa test, Nasal discharged eosinophil, Intradermal reaction and cedar-pollen specific IgE antibody. 4) A person with a medical history of rice allergy. 5) A person who has a disease which is undergoing treatment 6) A person with serious conditions such as diabetes, hepatic disease, and cardiac disease. 7) A person preliminarily ruled unfit to become a clinical study patient. 8) A person already in another clinical test when this clinical test begins. 9) A person who's presently breastfeeding, in pregnancy, or planning/wishing to be a pregnant during a period of clinical test. 10) A person whom trial investigator has assessed as mismatched participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptom of pollinosis Specific IgE antibody level to Japanese cedar pollen allergens Rhinoscopic Examination | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood Examination Pathologic Examination Urine Examination | — |
Countries
Japan
Contacts
Public ContactDaiya Asaka
The Jikei University, School of Medicine. Department of Otorhinolaryngology
Outcome results
None listed