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

Study Overview
=================
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

Official Title
-----------------
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

Conditions
-----------------
Rheumatic Arthritis

Intervention / Treatment
-----------------
* Biological: YHB1411-2: Level 2
* Biological: YHB1411-2: Level 3
* Biological: YHB1411-2: Level 4
* Biological: YHB1411-2: Level 5
* Biological: Placebo
* Biological: YHB1411-2: level 1


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YHB1411-2: Level 2<br>The ratio of Test Drug(YHB1411-2) to Placebo is 4 :1. | Biological: YHB1411-2: Level 2<br>* IV infusion<br>* Other names: Undecided;Biological: Placebo<br>* IV infusion<br>|
| Experimental: YHB1411-2: Level 3<br>The ratio of Test Drug(YHB1411-2) to Placebo is 13 :2. | Biological: YHB1411-2: Level 3<br>* IV infusion<br>* Other names: Undecided;Biological: Placebo<br>* IV infusion<br>|
| Experimental: YHB1411-2: Level 4<br>The ratio of Test Drug(YHB1411-2) to Placebo is 4 :1. | Biological: YHB1411-2: Level 4<br>* IV infusion<br>Biological: Placebo<br>* IV infusion<br>|
| Experimental: YHB1411-2: Level 5<br>The ratio of Test Drug(YHB1411-2) to Placebo is 4 :1. | Biological: YHB1411-2: Level 5<br>* IV infusion<br>* Other names: Undecided;Biological: Placebo<br>* IV infusion<br>|
| Experimental: YHB1411-2: Level 1<br>All investigational products are YHB1411-2(This level is pilot study). | Biological: YHB1411-2: level 1<br>* IV infusion<br>* Other names: Undecided;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Evaluation | Adverse Events, Physical examination, ECG, Vital sign, Clinical Laboratory Tests results, Chest X-ray | Participants will be followed for the duration of hospital stay(an expected average of 1 week) and out-patient visit for 8 weeks → Specified timepoints in the protocol. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic Evaluation |  | PK sampling : participants will be followed for the duration of hospital stay(an expected average of 1 week) and out-patient visit for 8 weeks → Specified timepoints in the protocol. | 
| Immunogenicity Evaluation | HAHA (Human anti human antibodies) measurement Neutralizing Antibody measurement: only if antibody formation has verified | HAHA measurement(blood sampling): pre-dose and out-patient visit for 8 weeks → Specified timepoints in the protocol. |