NCT01525147

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Yuhan Corporation · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

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

Detailed description

First in human Study

Conditions

• Rheumatic Arthritis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-06-01
• Completion: 2013-11-01
• First posted: 2012-02-02
• Last updated: 2014-07-10

Locations

1 site across 1 country: South Korea