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

ISU Abxis

Status and phase: Completed; Phase 1

Conditions: Gaucher Disease

Treatments: Drug: Placebo; Drug: ISU302

Study type: Interventional

Funder types: Industry

Identifiers

NCT01881633

ISU-002

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

24 participants in 4 patient groups, including a placebo group

ISU302

Experimental group

Description:

15 U/kg I.V. injection

Treatment:

Drug: ISU302

ISU302 30 U/kg

Experimental group

Description:

Drug ISU302 I.V. injection

Treatment:

Drug: ISU302

ISU302 60 U/kg

Experimental group

Description:

Drug ISU302 I.V. injection

Treatment:

Drug: ISU302

Placebo

Placebo Comparator group

Description:

ISU302 Placebo I.V. injection

Treatment:

Drug: Placebo