Rheumatic Arthritis
Conditions
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
Interventions
BIOLOGICALYHB1411-2: Level 2
IV infusion
BIOLOGICALYHB1411-2: Level 3
IV infusion
BIOLOGICALYHB1411-2: Level 4
IV infusion
BIOLOGICALYHB1411-2: Level 5
IV infusion
BIOLOGICALPlacebo
IV infusion
BIOLOGICALYHB1411-2: level 1
IV infusion
Sponsors
Yuhan Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male volunteers of aged between 20 to 45 years old at the time of screening 2. Volunteers weighing over 50 kg with body mass index between 18.0 \ 28.0 kg/m2 3. 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
1. 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 2. Presence of current tuberculosis or latent tuberculosis or have history of tuberculosis (confirmed by chest X-ray test or tuberculin skin test) 3. Have active infection such as chronic or topical infection 4. Have history of hospitalization or have received antibiotics due to serious infection within 1 month prior to the first administration 5. Have know hypersensitivity to biologicals 6. Have AST(SGOT) or/and ALT(SGPT) \> 1.5 times of normal upper limit at the time of screening 7. Shown positive results in any of HBsAg, HCV Ab, HIV Ab tests 8. Have history of drug abuse or shown positive reaction of drug abuse in urine test at the time of screening 9. Received any biological drugs including monoclonal antibody products or protein drugs within the last 6 months prior to the first administration 10. Participated in any other clinical trials within 2 months prior to the first administration of Investigational Product 11. 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 12. Subject who drink continuously (over 21 units/week, 1 unit = 10 g of pure alcohol) or who cannot quit drinking while hospitalized 13. Smoker (Subject can be enrolled if he/she had quit smoking within 3 months before the first administration of Investigational Product (Day 1)) 14. 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Evaluation | 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. | Adverse Events, Physical examination, ECG, Vital sign, Clinical Laboratory Tests results, Chest X-ray |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 measurement(blood sampling): pre-dose and out-patient visit for 8 weeks → Specified timepoints in the protocol. | 1. HAHA (Human anti human antibodies) measurement 2. Neutralizing Antibody measurement: only if antibody formation has verified |
Countries
South Korea
Outcome results
None listed