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A Dose-Block Randomized, Placebo Controlled (Double-blind), Active Controlled(Open-label), Dose-escalation Study

NCT02175056 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2015-10-06

No results posted yet for this study

Summary

The study design of this trial is a Dose-Block Randomized, Placebo controlled (Double-blind), Active Controlled(Open-label), Dose-escalation.

Conditions

  • Healthy Volunteers

Interventions

BIOLOGICAL

HL2351

Dose-escalation For 5 level dose groups A \~ E(each 1, 2, 4, 8, 12mg/kg), 10 subjects (8 for the study drug and 2 for placebo) are randomized to each dose group, and the study drug or placebo is subcutaneously administered for the relevant dose group.

BIOLOGICAL

Kineret(Anakinra)

Active comparator(group F) is implemented in parallel with dose groups A\~E in an open-label manner and 8 subjects subcutaneously administer Kineret® 100 mg.

Sponsors & Collaborators

  • Handok Inc.

    lead INDUSTRY

Principal Investigators

  • Hyeong Ki Lee, Professor · Clinical Trial Center, Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-01-31
Completion
2015-02-28

Countries

  • South Korea

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 NCT02175056 on ClinicalTrials.gov