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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01881633
Recruitment Status : Completed
First Posted : June 19, 2013
Last Update Posted : June 19, 2013
Sponsor:
Information provided by (Responsible Party):
ISU Abxis Co., Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Gaucher Disease Drug: ISU302 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official 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
Study Start Date : October 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gaucher Disease

Arm Intervention/treatment
Experimental: ISU302
15 U/kg I.V. injection
Drug: ISU302
Experimental: ISU302 30 U/kg
Drug ISU302 I.V. injection
Drug: ISU302
Experimental: ISU302 60 U/kg
Drug ISU302 I.V. injection
Drug: ISU302
Placebo Comparator: Placebo
ISU302 Placebo I.V. injection
Drug: Placebo



Primary Outcome Measures :
  1. Safety and tolerability [ Time Frame: From Screening to Day 5 post-dose ]

    Evaluation for safety data by treatment group/ Confirmative evaluation for serious adverse drug reaction/ Descriptive statistics (arithmetic mean and standard deviation) for quantitative analysis and evaluation of change from baseline/ Frequency counts for qualitative categorization of safety data

    Parameters:

    • Adverse events including subjective/objective symptoms
    • Physical examination
    • 12-lead ECG
    • Vital signs
    • Local tolerability test
    • Clinical laboratory test: Hematology, Coagulation, Blood Chemistry, Urinalysis
    • Immunogenicity


Secondary Outcome Measures :
  1. Pharmacokinetics [ Time Frame: Day1 ]

    Pharmacokinetic Parameter assessment using non-compartmental analysis from the concentration-time data/ Summary of Pharmacokinetic parameters by treatment group using descriptive statistics/ Dose proportionality

    Parameters: Cmax, AUCt, AUCinf, Tmax, t1/2, Clearance, Vd, MRTr




Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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).

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Responsible Party: ISU Abxis Co., Ltd.
ClinicalTrials.gov Identifier: NCT01881633    
Other Study ID Numbers: ISU-002
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: June 2013
Keywords provided by ISU Abxis Co., Ltd.:
gaucher disease, imiglucerase, ISU302
Additional relevant MeSH terms:
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Gaucher Disease
Sphingolipidoses
Lysosomal Storage Diseases, Nervous System
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Lipidoses
Lipid Metabolism, Inborn Errors
Lysosomal Storage Diseases
Metabolic Diseases
Lipid Metabolism Disorders