Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of YHB1411-2 in Healthy Male Volunteers
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
1 other identifier
interventional
49
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 26, 2012
CompletedFirst Posted
Study publicly available on registry
February 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedJuly 10, 2014
July 1, 2014
1.5 years
January 26, 2012
July 8, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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.
Study Arms (5)
YHB1411-2: Level 2
EXPERIMENTALThe ratio of Test Drug(YHB1411-2) to Placebo is 4 :1.
YHB1411-2: Level 3
EXPERIMENTALThe ratio of Test Drug(YHB1411-2) to Placebo is 13 :2.
YHB1411-2: Level 4
EXPERIMENTALThe ratio of Test Drug(YHB1411-2) to Placebo is 4 :1.
YHB1411-2: Level 5
EXPERIMENTALThe ratio of Test Drug(YHB1411-2) to Placebo is 4 :1.
YHB1411-2: Level 1
EXPERIMENTALAll investigational products are YHB1411-2(This level is pilot study).
Interventions
IV infusion
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, Irwon-dong, Gangnam-gu, 130-710, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Woo-Seung Huh, MD,PhD.
Samsung Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2012
First Posted
February 2, 2012
Study Start
December 1, 2011
Primary Completion
June 1, 2013
Study Completion
November 1, 2013
Last Updated
July 10, 2014
Record last verified: 2014-07