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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01881633
• Date of registration: 14/06/2013
• Prospective Registration: No
• Primary sponsor: ISU Abxis Co., Ltd.
• Public title: A Study of the Tolerability, Safety, and Pharmacokinetics of ISU302 in Healthy Volunteers
• Scientific title: 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
• Date of first enrolment: October 2010
• Target sample size: 24
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01881633
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
• Phase: Phase 1

Key inclusion & exclusion 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).



Age minimum: 20 Years
Age maximum: 45 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Gaucher Disease

Intervention(s)

Drug: ISU302

Drug: Placebo

Primary Outcome(s)

Safety and tolerability [Time Frame: From Screening to Day 5 post-dose]

Secondary Outcome(s)

Pharmacokinetics [Time Frame: Day1]

Secondary ID(s)

ISU-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors