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. ]
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. ]
- HAHA (Human anti human antibodies) measurement
- 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. ]
- HAHA (Human anti human antibodies) measurement
- 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