Status:
COMPLETED
Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of YHB1411-2 in Healthy Male Volunteers
Lead Sponsor:
Yuhan Corporation
Conditions:
Rheumatic Arthritis
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief 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
Eligibility Criteria
Inclusion
- Healthy male volunteers of aged between 20 to 45 years old at the time of screening
- Volunteers weighing over 50 kg with body mass index between 18.0 \~ 28.0 kg/m2
- Volunteers who has signed a written informed consent voluntarily, prior to any procedure, using a form that is approved by the local Institutional Review Board after detail explanation of the purpose, contents, and characteristic of the drug
Exclusion
- Have history or presence of clinically significant diseases in liver, kidney, gastrointestinal tract, nervous system, respiratory system, endocrine system, blood•tumor, cardiovascular, urinary system, and mental disorder
- Presence of current tuberculosis or latent tuberculosis or have history of tuberculosis (confirmed by chest X-ray test or tuberculin skin test)
- Have active infection such as chronic or topical infection
- Have history of hospitalization or have received antibiotics due to serious infection within 1 month prior to the first administration
- Have know hypersensitivity to biologicals
- Have AST(SGOT) or/and ALT(SGPT) \> 1.5 times of normal upper limit at the time of screening
- Shown positive results in any of HBsAg, HCV Ab, HIV Ab tests
- Have history of drug abuse or shown positive reaction of drug abuse in urine test at the time of screening
- Received any biological drugs including monoclonal antibody products or protein drugs within the last 6 months prior to the first administration
- Participated in any other clinical trials within 2 months prior to the first administration of Investigational Product
- Have donated whole blood within 2 months prior to the first administration of Investigational Product, or donated blood components or received transfusion within 1 month prior to the first administration of Investigational Product
- Subject who drink continuously (over 21 units/week, 1 unit = 10 g of pure alcohol) or who cannot quit drinking while hospitalized
- Smoker (Subject can be enrolled if he/she had quit smoking within 3 months before the first administration of Investigational Product (Day 1))
- Subject who is judged to be ineligible by principal investigator or sub-investigator according to various reasons including their abnormal test results (clinical laboratory test, chest X-ray test, 12-lead ECG)
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT01525147
Start Date
December 1 2011
End Date
November 1 2013
Last Update
July 10 2014
Active Locations (1)
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1
Samsung Medical Center
Seoul, Irwon-dong, Gangnam-gu, South Korea, 130-710