A Dose Block-randomized, Double-blind, Placebo-controlled, Single Dosing, Dose-escalation Phase I Clinical Trial to Evaluate the Tolerability, Safety, and Pharmacokinetics of ISU302 in Healthy Volunteers
A Dose Block-randomized, Double-blind, Placebo-controlled, Single Dosing, Dose-escalation Phase I Clinical Trial to Evaluate the Tolerability, Safety, and Pharmacokinetics of ISU302 in Healthy Volunteers
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of single dosing study with three ascending dose cohorts of ISU302 in healthy subjects.
Inclusion Criteria:
Healthy male volunteers, aged between ≥ 20 and ≤ 45 years old
Weight ≥ 50, with calculated body mass index of 17 and 25 kg/m2
Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and comply with the relevant instructions in written
Considered ineligible through screening test (such as medical history, physical examination, ECG, safety laboratory test) performed within 35 days prior to study start (dosing of investigational products)
Exclusion Criteria:
With symptoms indicating acute diseases within 28 days prior to start of study (dosing of investigational product)
History or presence of clinically significant and active cardiovascular, respiratory, renal, endocrine, hematological, gastrointestinal, central nervous system, psychiatric disorder, autoimmune disease, or malignant tumor
Any medical history that may affect drug absorption, distribution, metabolism and excretion(e.g., inflammatory gastric disease, gastric or intestinal ulcer, hepatic or renal disease)
With presence of clinically significant allergic disease (including mild allergic rhinitis or allergic dermatitis which does not need medication)
With presence of clinically significant hypersensitivity to any drugs
With hemolytic anemia, anemia due to blood loss (Hb < 14g/dL and Hct <42%)
With the results of safety laboratory test
Subject who has immune deficiency or medication with immune suppressants
Participation in other clinical study within 60 days prior to start of study (dosing of investigational products)
Use of any drugs, possibly affecting drug metabolizing enzymes, within 1 month prior dosing, or any drugs, possibly affecting the results of clinical trial within 10 days or use of drug was not passes 5 x half-life of drug
Donated whole blood within 60 days, or transfused within 20 days before the study
History of alcohol abuse (> 14 units/week) and the subject could not stop drinking alcohol beverage during study period
Heavy smoker (>10 cigarettes/day) or the subject could not stop smoking during study period
Unwillingness or inability to follow the procedures outlined in the protocol
Positive in pregnancy test in urine and unwilling to follow contraception during study period and following 3 months (for female subjects).