Clinical trial NCT01881633: A Study of the Tolerability, Safety, and Pharmacokinetics of ISU302 in Healthy Volunteers
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gaucher Disease
Keywords: gaucher disease, imiglucerase, ISU302
Lead sponsor: ISU Abxis Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-06-19
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility 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).

Primary outcomes:
measure: Safety and tolerability
timeFrame: From Screening to Day 5 post-dose
Secondary outcomes:
measure: Pharmacokinetics
timeFrame: Day1
Other outcomes:
Locations:
Study officials:
References: