Clinical trial NCT01525147: Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of YHB1411-2 in Healthy Male Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatic Arthritis
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2012-02-02
Enrollment: 49
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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)

Primary outcomes:
measure: Safety Evaluation
timeFrame: 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:
measure: Pharmacokinetic Evaluation
timeFrame: 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.
measure: Immunogenicity Evaluation
timeFrame: HAHA measurement(blood sampling): pre-dose and out-patient visit for 8 weeks → Specified timepoints in the protocol.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Irwon-dong, Gangnam-gu
Study officials:
affiliation: Samsung Medical Center
name: Woo-Seung Huh, MD,PhD.
role: PRINCIPAL_INVESTIGATOR
References: