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

Gaucher Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01881633
• Other study ID #: ISU-002
• Status: Completed
• Phase: Phase 1
• First received: June 14, 2013
• Last updated: June 18, 2013
• Start date: October 2010
• Est. completion date: November 2010

Study information

• Verified date: June 2013
• Source: ISU Abxis Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Gaucher Disease

Intervention

Drug:
• ISU302

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ISU Abxis Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability	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	From Screening to Day 5 post-dose	No
Secondary	Pharmacokinetics	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	Day1	No