cholera, travelers'
Conditions
Interventions
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 e
Sponsors
IMSUT Hospital, The Institute of Medical Science, The University of Tokyo
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactCenter for Translational Research
IMSUT Hospital, The Institute of Medical Science, The University of Tokyo Center for Translational Research
Outcome results
None listed