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

NCT04047160 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2022-07-07

No results posted yet for this study

Summary

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

Conditions

  • Primary Biliary Cholangitis (PBC)
  • Liver Cirrhosis, Biliary

Interventions

DRUG

OP-724

Twice a week for 4 hours continuous intravenous administration of OP-724

Sponsors & Collaborators

  • Ohara Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Japan Agency for Medical Research and Development

    collaborator OTHER_GOV

  • Kiminori Kimura, MD

    lead OTHER

Principal Investigators

  • Kiminori Kimura, MD · Tokyo Metropolitan Komagome Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-29
Primary Completion
2021-09-21
Completion
2022-03-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04047160 on ClinicalTrials.gov