A Study to Assess the Safety and Immunogenicity of the Drug CAT-354 in Healthy Japanese Subjects
- Registration Number
- NCT01093040
- Lead Sponsor
- MedImmune LLC
- Brief Summary
To assess the safety of the administration of the drug (CAT-354) in healthy Japanese subjects.
- Detailed Description
The study design allows a gradual escalation of dose with safety monitoring to ensure the safety of the subjects.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Male or female subjects aged 20 through 55 years at the time of screening
- Signed and dated written informed consent is obtained prior to any study related procedure taking place
- No significant abnormality on clinical examination or medical history (excluding atopic skin signs, symptoms and history)
- A normal 12-lead electrocardiogram (ECG) (no clinically significant abnormalities)
- Clinical chemistry, hematology and urinalysis results within the laboratory reference ranges or deemed not clinically significant by the Investigator
- A negative screen for drugs of abuse and alcohol
- The following reproductive criteria apply:
- Females(of child bearing potential) must have a negative pregnancy test prior to the dose of investigational product and, unless surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy), has a sterile male partner, or at least 2 years postmenopausal, or practices abstinence; must use 2 effective methods of avoiding pregnancy (including oral, transdermal, or implanted hormonal contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap with spermicide, or use of a condom with spermicide by the sexual partner) for 21 days prior to randomization, and must agree to continue using such precautions until 3 months after dosing with the investigational product; cessation of birth control after this point should be discussed with a responsible physician. A negative pregnancy test is required both at screening and prior to dosing.
- Males, unless surgically sterile, must use two effective methods of birth control with a female partner and must agree to continue using such contraceptive precautions from 21 days prior to randomization until 3 months after dosing with the investigational product.
- Japanese subjects. To be considered as 'Japanese', both of the subject's parents, and both sets of grandparents, must be Japanese. The subject must have been born in Japan, have a valid Japanese passport, and must not have lived outside Japan for more than 5 years.
- Body mass index (BMI) between 18 and 27 kg/m 2 , inclusive
- Able to comply with the requirements of the protocol
Exclusion Criteria
- Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
- Previously received monoclonal antibody, or a similar related protein, that might sensitize subjects to CAT-354 or to any component of the investigational product formulation
- History of an active infection within 4 weeks prior to screening, or evidence of clinically significant active infection, including ongoing chronic infection
- Any acute illness in the 14 days before Day 1 (Visit 2)
- Use of any medication (prescription or OTC) excluding hormonal contraception within 14 days (or 5-half lives, whichever is longer) of Day 1 dosing
- Involvement in another study of investigational medicinal product; within 2 months of the start of this study (Day 1) for small molecules, within 3 months of the start of this study for antibodies, or 5 half lives of the previously administered investigational product, whichever is the longer
- Any blood donation or significant loss of blood within 56 days of study initiation or plasma donation within 7 days of study initiation
- Subjects with immunodeficiency disorders
- Subjects who have a positive test for, or have been treated for hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
- Any active concomitant disease including psychological disorders
- Subject is a participating Investigator, sub-Investigator, study coordinator, or employee of a participating Investigator, or is a first-degree relative of the aforementioned.
- Any factor which, in the opinion of the Investigator, would be associated with poor adherence to the protocol
- Female subjects: lactation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 2 CAT-354 CAT-354 will be administered by SC injection Cohort 3 CAT 354 CAT-354 will be administered by SC injection Cohort 1 CAT-354 CAT-354 will be administered by SC injection
- Primary Outcome Measures
Name Time Method Safety Study Day 71 The safety and tolerability of a single dose SC injection of CAT-354 in healthy male and/or female Japanese subjects will be assessed through the incidence of adverse events (AEs), and the assessment of vital signs, physical examinations, laboratory parameters, and electrocardiograms.
- Secondary Outcome Measures
Name Time Method Immunogenicity Study Day 71 The PK variables and IM variables of CAT-354 in healthy Japanese subjects will be evaluated. The incidence rate of positive serum antibodies to CAT-354 will be reported by treatment group.
Trial Locations
- Locations (1)
Research Site
🇺🇸Glendale, California, United States