Evaluation of the safety of OsCr11-PB which is prepared from transgenic rice containing peptides from Japanese cedar pollen allergens.

Evaluation of the safety of OsCr11-PB which is prepared from transgenic rice containing peptides from Japanese cedar pollen allergens. - Evaluation of the safety of OsCr11-PB which is prepared from transgenic rice containing peptides from Japanese cedar pollen allergens.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016281

Enrollment

Registered

2015-01-31

Start date

2015-01-28

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adult

Interventions

Evaluation of the safety of a OsCr11-PB capsule or a placebo capsule Evaluation of the safety of 2 OsCr11-PB capsules or 2 placebo capsules Evaluation of the safety of 4 OsCr11-PB capsules or 4 plac

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy Adult aged between 20yo and 65yo.

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) Cedar pollen or Cypress allergen-specific IgE antibody values over Class II. 4) Preliminarily examined positive at more than one of followings; Intradermal reaction and cedar-pollen specific IgE antibody. 5) A person who shows House dust specific IgE antibody valued over Class V 6) A person with a medical history of gelatin allergy. 7) A person with a medical history of rice allergy. 8) A person who is imperative to use medicine such as anti-allergic agent and steroidal chemicals that potentially influence the outcome of evaluation. 9) A person who underwent an operation that is accompanied to nasal disorder within last 2years, or has nasal disorder such as acute/chronic-rhinitis, rhinopolypus, hypertronic rhinitis, septal deviation, sinusitis which all are potentially hinder to the outcome of evaluation. 10) A person who received immunotherapy in the past 11) A person who takes beta-blocker in order to treat complecating disorders such as hypertension, and / or cardiac disorder. 12)A person who takes alpha-blocker in order to treat complecating disorders such as prostatic hyperplasia. 13)A person who is complecated by immunodeficiency disorder, cancer, or severe enemia. 14) A person who is complecated by asthma. 15) A person who has a disease which is undergoing treatment 16) A person with serious conditions such as diabetes, hepatic disease, and cardiac disease. 17) A person who's pre-clinical test showed AST(GOT), ALT(GRT), Creatinine or BUN value exceed 1.5 times the upper limit or normal, or has assessed as mismatched participant. 18) A person already in another clinical test when this clinical test begins. 19) A person who's presently breastfeeding, in pregnancy, or planning/wishing to be a pregnant during a period of clinical test. 20) 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

asaka@jikei.ac.jp03-3433-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026