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2ccPA Study in Patients With Symptomatic Knee Osteoarthritis

NCT04229394 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-04-30

No results posted yet for this study

Summary

This clinical trial is designed to determine safety and tolerability as well as the MTD of a single-dose 2ccPA and PK data in symptomatic knee OA.

Conditions

  • Osteoarthritis (OA) of the Knee

Interventions

DRUG

2ccPA

Four dose cohorts (50 μg, 200 μg, 800 μg, and 2,400 μg) are planned in this study sequentially. study group: one dose intra-articular on day1

DRUG

placebo

A total of 8 subjects will be recruited and randomized in each dose cohort with a 3:1 ratio (6 subjects in the 2ccPA treatment arm and 2 subjects in the placebo arm). control group: one dose intra-articular on day 1

Sponsors & Collaborators

  • Orient Europharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Hsiang-Cheng Chen, PHD · Tri-Service General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-13
Primary Completion
2021-03-22
Completion
2021-03-22
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

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Entities

Drugs

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 NCT04229394 on ClinicalTrials.gov