Pharmacokinetics and Safety Study of LBAL in Healthy Subjects

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02206867
• Other study ID #: LG-ALCL001
• Status: Completed
• Phase: Phase 1
• First received: July 30, 2014
• Last updated: June 12, 2015
• Start date: August 2014
• Est. completion date: February 2015

Study information

• Verified date: June 2015
• Source: LG Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Biological:
• LBAL
Anti-inflammatory agents
• Humira
Anti-inflammatory agents

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
LG Life Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the concentration-time curve of the analyte in serum over the time interval from 0 extrapolated to infinity		0 to 65 days	No
Primary	Maximum measured concentration of the analyte in serum		0 to 65 days	No