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

First in human Study

Inclusion criteria

• 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 criteria

• 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)