Unique ID issued by UMIN | UMIN000010212 |
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Receipt number | R000011959 |
Scientific Title | Evaluation of the safety of transgenic rice containing peptides from Japanese cedar pollen allergens |
Date of disclosure of the study information | 2013/03/12 |
Last modified on | 2014/12/29 11:31:44 |
Evaluation of the safety of transgenic rice containing peptides from Japanese cedar pollen allergens
Evaluation of the safety of transgenic rice containing peptides from Japanese cedar pollen allergens
Evaluation of the safety of transgenic rice containing peptides from Japanese cedar pollen allergens
Evaluation of the safety of transgenic rice containing peptides from Japanese cedar pollen allergens
Japan |
Healthy Individual
Adult |
Others
NO
The examination aiming to evaluate safety
Safety
Phase I
Symptom of pollinosis
Specific IgE antibody level to Japanese cedar pollen allergens
Rhinoscopic Examination
Blood Examination
Pathologic Examination
Urine Examination
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Dose comparison
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
3
Prevention
Medicine |
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 pollen allergens.
Evauation of the safety of 80g of transgenic rice containing peptides from Japanese cedar pollen allergens.
20 | years-old | <= |
65 | years-old | > |
Male and Female
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.
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.
18
1st name | |
Middle name | |
Last name | Saburo Saito |
The Jikei University, School of Medicine
Institute of DNA medicine. Department of Molecular Immunology
3-25-8 Nishi Shinbashi, Minato-ku TOKYO, 105-8461 JAPAN
03-3433-1111
misaburo@jikei.ac.jp
1st name | |
Middle name | |
Last name | Daiya Asaka |
The Jikei University, School of Medicine.
Department of Otorhinolaryngology
3-25-8 Nishi Shinbashi, Minato-ku TOKYO, 105-8461 JAPAN
03-3433-1111
asaka@jikei.ac.jp
Department of Molecular Immunology, Institute of DNA Medicine, The Jikei University, School of Medicine.
Agri-Health Translational Research
Project
National Institute of Agrobiological Sciences (NIAS)
SATAKE Corporation
NO
東京慈恵会医科大学附属病院
2013 | Year | 03 | Month | 12 | Day |
Unpublished
Completed
2012 | Year | 08 | Month | 16 | Day |
2012 | Year | 10 | Month | 17 | Day |
2013 | Year | 04 | Month | 10 | Day |
2013 | Year | 04 | Month | 29 | Day |
2013 | Year | 05 | Month | 10 | Day |
2013 | Year | 06 | Month | 30 | Day |
2013 | Year | 03 | Month | 11 | Day |
2014 | Year | 12 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011959
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