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

NCT01093040 | Completed Phase 1

• 1 other identifier: MI-CP224
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Immunogenicity

  Study Day 71

Study Arms (3)

Cohort 1

EXPERIMENTAL

CAT-354 will be administered by SC injection

Drug: CAT-354

Cohort 2

EXPERIMENTAL

CAT-354 will be administered by SC injection

Drug: CAT-354

Cohort 3

EXPERIMENTAL

CAT-354 will be administered by SC injection

Drug: CAT 354

Interventions

CAT-354 DRUG

150 mg CAT-354 or placebo given SC on Day 1

Cohort 1

CAT 354 DRUG

600 mg CAT-354 or placebo given SC on Day 1

Cohort 3

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MedImmune LLC: lead
• MedImmune Ltd: collaborator
• AstraZeneca: collaborator

Study Sites (1)

Research Site

Glendale, California, 91206, United States

Location

MeSH Terms

Interventions

tralokinumab

Study Officials

• Katsuro Yagawa, M.D.

  Astra Zeneca K.K.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2010
• First Posted: March 25, 2010
• Study Start: April 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: October 1, 2010
• Last Updated: August 30, 2012

Record last verified: 2012-08

Locations

US (1)