A Study to Assess the Safety and Immunogenicity of the Drug CAT-354 in Healthy Japanese Subjects

Study Overview
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Brief Summary
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To assess the safety of the administration of the drug (CAT-354) in healthy Japanese subjects.

Detailed Description
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The study design allows a gradual escalation of dose with safety monitoring to ensure the safety of the subjects.

Official Title
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A Phase I, Single-Center, Single-blind, Randomized, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Immunogenicity of CAT-354 Following Subcutaneous Administration in Healthy Male and Female Japanese Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: CAT-354
* Drug: CAT-354
* Drug: CAT 354


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>CAT-354 will be administered by SC injection | Drug: CAT-354<br>* 150 mg CAT-354 or placebo given SC on Day 1<br>|
| Experimental: Cohort 2<br>CAT-354 will be administered by SC injection | Drug: CAT-354<br>* 300 mg CAT-354 or placebo given SC on Day 1<br>|
| Experimental: Cohort 3<br>CAT-354 will be administered by SC injection | Drug: CAT 354<br>* 600 mg CAT-354 or placebo given SC on Day 1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | 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. | Study Day 71 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity | 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. | Study Day 71 |