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

Study identifier:MI-CP224

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

Healthy

Phase

Phase 1

Healthy volunteers

Yes

Study drug

CAT-354, CAT 354

Sex

All

Actual Enrollment

Study type

Interventional

Age

20 Years - 55 Years

Date

Study Start Date: 01 Apr 2010

Primary Completion Date: 01 May 2010

Study Completion Date: 01 Oct 2010

Study design

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2012 by MedImmune LLC

Collaborators

MedImmune Ltd., AstraZeneca

Inclusion and exclusion criteria

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

No locations available

Arms	Assigned Interventions
Experimental: Cohort 1 CAT-354 will be administered by SC injection	Drug: CAT-354 150 mg CAT-354 or placebo given SC on Day 1
Experimental: Cohort 2 CAT-354 will be administered by SC injection	Drug: CAT-354 300 mg CAT-354 or placebo given SC on Day 1
Experimental: Cohort 3 CAT-354 will be administered by SC injection	Drug: CAT 354 600 mg CAT-354 or placebo given SC on Day 1

Documents available

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Trial Results Summaries
Available here

Contacts

Contact

Edward Piper

[email protected]

Investigators

Principal Investigator

Katsuro Yagawa

Astra Zeneca K.K.