NCT02175056

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

A Dose-Block Randomized, Placebo Controlled (Double-blind), Active Controlled(Open-label), Dose-escalation Study to Investigate the Tolerability, and Pharmacokinetics/Pharmacodynamics of HL2351 After a Single Subcutaneous Administration in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Handok Inc. · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

* Extended in vivo half-life of HL2351 is also anticipated to provide improved therapeutic efficacy based on sustained maintenance of an effective concentration. * A safety concern may be addressed by utilizing IL-1Ra that is being used after getting approval by the EMA and the US FDA and known to be relatively safe, and the Fc fusion technology that has been already applied to various therapeutic agents.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-01-01
• Completion: 2015-02-01
• First posted: 2014-06-26
• Last updated: 2015-10-06

Locations

1 site across 1 country: South Korea