CompletedPhase 1

Safety, Tolerability of OP-724 in Patients With Primary Biliary Cholangitis (Phase I)

Japan7 participantsStarted 2019-08-29

Plain-language summary

To evaluate the safety and pharmacokinetics of OP-724 and to determine the recommended dose of OP-724 against Primary Biliary Cholangitis patients.

Age range20 Years – 74 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Histologically, chronic non-suppurative destructive cholangitis (CNSDC) is found and the laboratory findings are consistent as PBC.
✓. A positive antimitochondrial antibody (AMA) with no histologic findings of CNSDC but showing a histology consistent with PBC.
✓. There is no experience of histologic search, but AMA is positive and it is considered as PBC from clinical image and course.

Occurrence Rate of Serious Adverse Events (Side Effects)

Timeframe: 28 days after the last administration of OP-724

NCT IDNCT04047160

SponsorKiminori Kimura, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-09-21