Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of YHB1411-2 in Healthy Male Volunteers
NCT ID: NCT01525147
Last Updated: 2014-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
49 participants
INTERVENTIONAL
2011-12-31
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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YHB1411-2: Level 2
The ratio of Test Drug(YHB1411-2) to Placebo is 4 :1.
YHB1411-2: Level 2
IV infusion
Placebo
IV infusion
YHB1411-2: Level 3
The ratio of Test Drug(YHB1411-2) to Placebo is 13 :2.
YHB1411-2: Level 3
IV infusion
Placebo
IV infusion
YHB1411-2: Level 4
The ratio of Test Drug(YHB1411-2) to Placebo is 4 :1.
YHB1411-2: Level 4
IV infusion
Placebo
IV infusion
YHB1411-2: Level 5
The ratio of Test Drug(YHB1411-2) to Placebo is 4 :1.
YHB1411-2: Level 5
IV infusion
Placebo
IV infusion
YHB1411-2: Level 1
All investigational products are YHB1411-2(This level is pilot study).
YHB1411-2: level 1
IV infusion
Interventions
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YHB1411-2: Level 2
IV infusion
YHB1411-2: Level 3
IV infusion
YHB1411-2: Level 4
IV infusion
YHB1411-2: Level 5
IV infusion
Placebo
IV infusion
YHB1411-2: level 1
IV infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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)
20 Years
45 Years
MALE
Yes
Sponsors
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Yuhan Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Woo-Seung Huh, MD,PhD.
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Locations
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Samsung Medical Center
Seoul, Irwon-dong, Gangnam-gu, South Korea
Countries
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Other Identifiers
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YHB1411-2-101
Identifier Type: -
Identifier Source: org_study_id
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