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Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of YHB1411-2 in Healthy Male Volunteers

NCT01525147 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2014-07-10

No results posted yet for this study

Summary

A block-randomized, double-blind, placebo-controlled, single-dose escalating, phase I clinical trial to evaluate the safety, tolerability and pharmacokinetics of YHB1411-2 in healthy male volunteers

Conditions

  • Rheumatic Arthritis

Interventions

BIOLOGICAL

YHB1411-2: Level 2

IV infusion

BIOLOGICAL

YHB1411-2: Level 3

IV infusion

BIOLOGICAL

YHB1411-2: Level 4

IV infusion

BIOLOGICAL

YHB1411-2: Level 5

IV infusion

BIOLOGICAL

Placebo

IV infusion

BIOLOGICAL

YHB1411-2: level 1

IV infusion

Sponsors & Collaborators

  • Yuhan Corporation

    lead INDUSTRY

Principal Investigators

  • Woo-Seung Huh, MD,PhD. · Samsung Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-06-30
Completion
2013-11-30

Countries

  • South Korea

Study Locations

More Related Trials

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 NCT01525147 on ClinicalTrials.gov