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

PHASE1CompletedINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

May 31, 2014

Primary Completion Date

January 31, 2015

Study Completion Date

February 28, 2015

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.

Trial Locations (1)

Unknown

HANDOK Inc., Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Handok Inc.

INDUSTRY