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
Overview
- Phase
- Phase 1
- Intervention
- ISU302
- Conditions
- Gaucher Disease
- Sponsor
- ISU Abxis Co., Ltd.
- Enrollment
- 24
- Primary Endpoint
- Safety and tolerability
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
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
- •AST (Aspartate Transaminase) or ALT (Alanine Transaminase) \> 1.5 times of upper normal limit
- •Total bilirubin \> 1.5 times of upper normal limit
- •Subject who has immune deficiency or medication with immune suppressants
Arms & Interventions
ISU302 30 U/kg
Drug ISU302 I.V. injection
Intervention: ISU302
ISU302 60 U/kg
Drug ISU302 I.V. injection
Intervention: ISU302
Placebo
ISU302 Placebo I.V. injection
Intervention: Placebo
ISU302
15 U/kg I.V. injection
Intervention: ISU302
Outcomes
Primary Outcomes
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 Outcomes
- Pharmacokinetics(Day1)