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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: First in human Study
Sponsor: Yuhan Corporation

Current Primary Outcome: 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. ]

Adverse Events, Physical examination, ECG, Vital sign, Clinical Laboratory Tests results, Chest X-ray


Original Primary Outcome:

  • Safety Evaluation: Pyhsical examinations [ 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. ]
  • Safety Evaluation: Electrocardiogram [ 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. ]
    Tripled 12-Lead ECG
  • Safety Evaluation: Vital sings [ 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. ]
  • Safety Evaluation: Clinical Laboratory Tests [ 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. ]
  • Safety Evaluation: Medical examination interview [ 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. ]
    Verified adverse events through a medical examination interview and investigator's observation in addition to voluntary reporting.


Current Secondary Outcome:

  • 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. ]
  • Immunogenicity Evaluation [ Time Frame: 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


Original Secondary Outcome:

  • 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. ]
  • Immunogeneticity Evaluation [ Time Frame: 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


Information By: Yuhan Corporation

Dates:
Date Received: January 26, 2012
Date Started: December 2011
Date Completion:
Last Updated: July 8, 2014
Last Verified: July 2014