Pharmacokinetics and Safety Study of LBAL in Healthy Subjects

A Randomized, Double-Blind, Parallel-Group Clinical Study to Compare Pharmacokinetics, Safety and Tolerability of LBAL 40 mg With Humira® 40 mg After a Single Subcutaneous Administration in Healthy Male Volunteers

To compare PK, safety and tolerability of LBAL developed by LG Life Sciences Ltd. With those of Humira®.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Biological: LBAL; Biological: Humira

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. 20-45 years old healthy males
2. Body mass index 19.0 ~ 28.0 kg/m2

Exclusion Criteria:

1. Diagnosis of current or latent tuberculosis (TB); history of severe active chronic or local infection including TB
2. Severe infection (e.g. sepsis) requiring admission or antibiotics treatment within four weeks prior to administration
3. Clinically relevant previous or concomitant disease including hepatic, renal, neurological, respiratory, gastrointestinal, endocrine, hematologic, oncologic, cardiovascular, urinary, musculoskeletal or psychiatric, autoimmune disease/disorders
4. Chronic or relevant acute infections. A negative result for human immunodeficiency virus (HIV), Hepatitis B (Hep B), and hepatitis C (Hep C) is required for participation (i.e. HIV Ab, HBsAg, HBcAb, HCV Ab)
5. Fever greater than 38.3℃ within a week prior to administration of study drug
6. Previous or current drug abuse

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LBAL; Developed by LG Life Sciences	Biological: LBAL; Anti-inflammatory agents; Other Names: Adalimumab
Active Comparator: Humira®; Abbvie	Biological: Humira; Anti-inflammatory agents; Other Names: Adalimumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the concentration-time curve of the analyte in serum over the time interval from 0 extrapolated to infinity	0 to 65 days
Maximum measured concentration of the analyte in serum	0 to 65 days

Collaborators and Investigators

• Sponsor: LG Life Sciences
• Investigators: Principal Investigator: Kyung-Sang Yu, M.D., Ph.D., M.B.A, Dep. of Clnical Pharmacology, Seoul National University College of Medicine and Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: July 30, 2014
• First Submitted That Met QC Criteria: July 30, 2014
• First Posted (Estimate): August 1, 2014

Study Record Updates

• Last Update Posted (Estimate): June 15, 2015
• Last Update Submitted That Met QC Criteria: June 12, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Inflammatory Agents; Antirheumatic Agents; Adalimumab
• Other Study ID Numbers: LG-ALCL001