A Study of the Tolerability, Safety, and Pharmacokinetics of ISU302 in Healthy Volunteers

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: ISU Abxis Co., Ltd.

Criteria

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

• BMI = (Weight [kg])/(height [m])2

• 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

1. AST (Aspartate Transaminase) or ALT (Alanine Transaminase) > 1.5 times of upper normal limit

2. Total bilirubin > 1.5 times of upper normal limit

• 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).