NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2071230006

Registered date:12/04/2023

A phase I study of KDH-136

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedHealth Conditions
Date of first enrollment03/10/2023
Target sample size14
Countries of recruitment
Study typeInterventional
Intervention(s)Single dose of KDH-136 or placebo

Outcome(s)

Primary OutcomeSafety, Pharmacokinetics
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximum< 65age old
GenderBoth
Include criteriaSubjects aged 18 years or older but less than 65 years at the time of informed consent.
Exclude criteria-Subject who has with complications requiring treatment(hypertension, diabetes mellitus, cardiovascular disease, respiratory disease, gastrointestinal disease, renal disease, autoimmune disease, psychiatric disease, and cancer etc.). -Subject who has with cancer, are diagnosed high chance of recurrence. -Subject who has donated whole blood (400 mL or more) within 16 weeks, whole blood (200 mL or more) within 4 weeks or blood component (plasma component, platelet component) within 2 weeks prior to informed consent for this study. -Subject who had a positive result for HBs antigen, HCV antibody or HIV antigen/antibody and is suspected to infect them. -Subject who does not agree to contraception always using double barrier method(condom and pessary, condom and spermicide jelly, spermicide and film, pessary and spermicide jelly, spermicide jelly and film) or intrauterine device etc. -Subject who is in the opinion of the investigator etc., unsuitable in any other way to participate in this study.

Related Information

Contact

Public contact
Name - - Contact for clinical trial information
Address 4-14, Nihonbashi-honcho 3-chome, Chuo-ku, Tokyo Tokyo Japan 103-8433
Telephone +81-3-3279-7836
E-mail msdo@kowa.co.jp
Affiliation Kowa Dental Health Co.,Ltd.
Scientific contact
Name Nakamura Mitsumasa
Address 4-14, Nihonbashi-honcho 3-chome, Chuo-ku, Tokyo Tokyo Japan 103-8433
Telephone +81-3-3279-7891
E-mail minakamu@kowa.co.jp
Affiliation Kowa Dental Health Co.,Ltd.