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A Phase 2a Study to Assess Safety, Daily Symptoms, PK, and Biomarkers of YPL-001 in COPD Patients

NCT02272634 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2023-07-14

Study results available
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Summary

This is a Phase 2a, proof-of-concept, multicenter, randomized, double-blind, double dummy, 3-treatment, parallel study, with low and high YPL 001 doses (low dose and high dose twice daily \[BID\]) and a placebo control in moderate to severe Chronic Obstructive Pulmonary Disease (COPD) patients.

Conditions

Interventions

DRUG

YPL-001 80 mg

twice daily \[BID\]

DRUG

YPL-001 160 mg

twice daily \[BID\]

DRUG

Placebo

twice daily \[BID\]

Sponsors & Collaborators

  • Yungjin Pharm. Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Gerard J Criner, MD · Temple University

  • Mark T Dransfield, MD · The Kirklin Clinic of UAB Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-04
Primary Completion
2017-11-08
Completion
2017-11-08

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02272634 on ClinicalTrials.gov