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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yuhan Corporation
ClinicalTrials.gov Identifier:
NCT01525147
First received: January 26, 2012
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Rheumatic Arthritis
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
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Yuhan Corporation:

Primary Outcome Measures:
  • Safety Evaluation [ Time Frame: 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. ] [ Designated as safety issue: No ]
    Adverse Events, Physical examination, ECG, Vital sign, Clinical Laboratory Tests results, Chest X-ray


Secondary Outcome Measures:
  • Pharmacokinetic Evaluation [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • Immunogenicity Evaluation [ Time Frame: HAHA measurement(blood sampling): pre-dose and out-patient visit for 8 weeks → Specified timepoints in the protocol. ] [ Designated as safety issue: No ]
    1. HAHA (Human anti human antibodies) measurement
    2. Neutralizing Antibody measurement: only if antibody formation has verified


Enrollment: 49
Study Start Date: December 2011
Study Completion Date: November 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: YHB1411-2: Level 2
The ratio of Test Drug(YHB1411-2) to Placebo is 4 :1.
Biological: YHB1411-2: Level 2
IV infusion
Other Name: Undecided
Biological: Placebo
IV infusion
Experimental: YHB1411-2: Level 3
The ratio of Test Drug(YHB1411-2) to Placebo is 13 :2.
Biological: YHB1411-2: Level 3
IV infusion
Other Name: Undecided
Biological: Placebo
IV infusion
Experimental: YHB1411-2: Level 4
The ratio of Test Drug(YHB1411-2) to Placebo is 4 :1.
Biological: YHB1411-2: Level 4
IV infusion
Biological: Placebo
IV infusion
Experimental: YHB1411-2: Level 5
The ratio of Test Drug(YHB1411-2) to Placebo is 4 :1.
Biological: YHB1411-2: Level 5
IV infusion
Other Name: Undecided
Biological: Placebo
IV infusion
Experimental: YHB1411-2: Level 1
All investigational products are YHB1411-2(This level is pilot study).
Biological: YHB1411-2: level 1
IV infusion
Other Name: Undecided

Detailed Description:

First in human Study

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01525147

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Irwon-dong, Gangnam-gu, Korea, Republic of, 130-710
Sponsors and Collaborators
Yuhan Corporation
Investigators
Principal Investigator: Woo-Seung Huh, MD,PhD. Samsung Medical Center
  More Information

No publications provided

Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT01525147     History of Changes
Other Study ID Numbers: YHB1411-2-101
Study First Received: January 26, 2012
Last Updated: July 8, 2014
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Rheumatic Fever
Arthritis
Bacterial Infections
Gram-Positive Bacterial Infections
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Streptococcal Infections

ClinicalTrials.gov processed this record on October 20, 2014