Healthy
Conditions
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.
Interventions
DRUGCAT-354
150 mg CAT-354 or placebo given SC on Day 1
DRUGCAT 354
600 mg CAT-354 or placebo given SC on Day 1
Sponsors
MedImmune Ltd
AstraZeneca
MedImmune LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed