A phase I study of KDH-136

JRCT ID: jRCT2071230006

Registered date:12/04/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Health Conditions
• Date of first enrollment: 03/10/2023
• Target sample size: 14
• Study type: Interventional
• Intervention(s): Single dose of KDH-136 or placebo

Outcome(s)

• Primary Outcome: Safety, Pharmacokinetics

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 65age old
• Gender: Both
• Include criteria: Subjects 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

• Primary Sponsor: Mitsumasa Nakamura