Evaluation of safety and tolerability of mesenchymal stem cell mobilization factor KOI2 (Phase 1 study ) - Evaluation of safety and tolerability of mesenchymal stem cell mobilization factor KOI2 (Phase 1 study )

Osaka University Hospital0 个研究点目标入组 48 人开始时间: 2015年7月16日最近更新: 2023年10月17日

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•1) A subject who has liver, kidney, GI, respiratory, heart and a blood system disease 2) A subject who has a past histroy of drug dependency 3) A subject who is difficult for intravenous administration (including episodes of vagal reflex syncope) 4) A subject who has the past of clinically significant drug allergy symptom and allergy to vaccine( eanaphylactic shock, severe food allergy, hives, recurrent dermatitis, drug hypersensitivity, allergy to protein preparation, vascular edema) 5) A subject who has clinically important abnormal laboratory data by a blood test or urine test at the time of screening 6) A subject who is HIV Ab, HBs Ag, or HCV Ab positive by screening examination 7) Screening or baseline Qtc is over 450 msec or QRS interval is over 120 msec by 12-lead electrocardiogram 8) Screening or baseline BP is over 140/90 mmHg or below 100/50, or HR is out of the range of 40-100 after 5 minutes rest 9) A subject who has fever(body temperature over 37 degrees Celsius) 10) A subject who participated in other clinical trials within four months and received a clinical trial drug (including a placebo) 11) A subject using prescribed drug and/or Over-The-Counter drugs within 14 days 12) The person who lost more than 400 mL blood within 12 weeks or 200 ml blood within 4 weeks(by blood donation, etc.) 13) Ineligible by other reasons judged by the investigators

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