Unique ID issued by UMIN | UMIN000018001 |
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Receipt number | R000020832 |
Scientific Title | A phase I clinical trial of rice-based oral cholera vaccine IMSUT-MR1501 in healthy volunteers |
Date of disclosure of the study information | 2015/06/23 |
Last modified on | 2022/12/15 11:23:42 |
A phase I clinical trial of rice-based oral cholera vaccine IMSUT-MR1501 in healthy volunteers
A phase I clinical trial of rice-based oral cholera vaccine IMSUT-MR1501
A phase I clinical trial of rice-based oral cholera vaccine IMSUT-MR1501 in healthy volunteers
A phase I clinical trial of rice-based oral cholera vaccine IMSUT-MR1501
Japan |
cholera, travelers' diarrhea
Medicine in general | Gastroenterology | Infectious disease |
Others
NO
1) Assessment of the safety and tolerance of IMSUT-MR1501 administered orally every other week for a total of 4 doses.
2) Exploratory evaluation of immunological effects of IMSUT-MR1501, in order to identify efficacy endpoints for future clinical trials.
Safety
Exploratory
Explanatory
Phase I
The safety of IMSUT-MR1501 is evaluated for 16 weeks, based on the assessment of adverse events, vital signs (body temperature, blood pressure, and pulse rate), electrocardiograms, and laboratory tests including serum IgE antibodies specific to rice proteins.
Immunological effects of IMSUT-MR1501 are preliminarily evaluated by analyzing the levels of serum IgG/IgA antibodies and fecal IgA antibodies specific to cholera toxin B subunit (CTB) and antibody-producing B lymphocytes.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
YES
Central registration
2
Prevention
Vaccine |
Sequential-cohort dose-escalation trial (3 dose-escalation cohorts of 20 subjects). In each cohort, 10 subjects are randomly assigned to the IMSUT-MR1501 arm, and IMSUT-MR1501 is administered orally every other week for a total of 4 doses. Dosing is as follows:
Cohort 1 1 g of IMSUT-MR1501
Cohort 2 3 g of IMSUT-MR1501
Cohort 3 6 g of IMSUT-MR1501
Sequential-cohort dose-escalation trial (3 dose-escalation cohorts of 20 subjects). In each cohort, 10 subjects are randomly assigned to the Placebo arm, and Placebo is administered orally every other week for a total of 4 doses. Dosing is as follows:
Cohort 1 1 g of Placebo
Cohort 2 3 g of Placebo
Cohort 3 6 g of Placebo
20 | years-old | <= |
40 | years-old | >= |
Male
1) Able and willing to give valid written informed consent
2) Healthy Japanese male aged 20-40
3) Measurable serum and fecal antibodies against CTB
1) History of allergy to rice
2) History of cholera and/or travellers' diarrhea
3) Constipation with poor responses to laxative treatment
4) Abnormal results on hepatic, renal, and/or hematologic screening tests
5) Use of any prescription drugs within 14 days before dosing and/or any over-the-counter drugs within 7 days before dosing
6) Unable or unwilling to use medically acceptable means of contraception
7) Any condition that, in the Investigator's opinion, might not be suitable for the trial
60
1st name | |
Middle name | |
Last name | Hirotoshi Tanaka |
IMSUT Hospital, The Institute of Medical Science, The University of Tokyo
Department of Rheumatology and Allergy
4-6-1 Shirokanedai, Minato-ku, Tokyo, Japan
03-3443-8111
dctsm@ims.u-tokyo.ac.jp
1st name | |
Middle name | |
Last name | Center for Translational Research |
IMSUT Hospital, The Institute of Medical Science, The University of Tokyo
Center for Translational Research
4-6-1 Shirokanedai, Minato-ku, Tokyo, Japan
03-5449-5462
http://www.ims.u-tokyo.ac.jp/tr/entry.html
dctsm@ims.u-tokyo.ac.jp
IMSUT Hospital, The Institute of Medical Science, The University of Tokyo
Japan Agency for Medical Research and Development
Japanese Governmental office
Japan
NO
2015年5月7日、初回
東京大学医科学研究所附属病院(東京都)
2015 | Year | 06 | Month | 23 | Day |
Unpublished
Completed
2015 | Year | 05 | Month | 18 | Day |
2015 | Year | 06 | Month | 30 | Day |
2016 | Year | 05 | Month | 11 | Day |
2016 | Year | 12 | Month | 16 | Day |
2016 | Year | 12 | Month | 16 | Day |
2016 | Year | 12 | Month | 16 | Day |
2015 | Year | 06 | Month | 22 | Day |
2022 | Year | 12 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020832
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