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

This study has been completed.
Sponsor:
Collaborators:
MedImmune Ltd
AstraZeneca
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01093040
First received: March 19, 2010
Last updated: August 29, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention Phase
Healthy
Drug: CAT-354
Drug: CAT 354
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Safety [ Time Frame: Study Day 71 ] [ Designated as safety issue: Yes ]
    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:
  • Immunogenicity [ Time Frame: Study Day 71 ] [ Designated as safety issue: No ]
    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.


Enrollment: 30
Study Start Date: April 2010
Study Completion Date: October 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01093040

Locations
United States, California
Research Site
Glendale, California, United States, 91206
Sponsors and Collaborators
MedImmune LLC
MedImmune Ltd
AstraZeneca
Investigators
Study Director: Katsuro Yagawa, M.D. Astra Zeneca K.K.
  More Information

Additional Information:
No publications provided

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01093040     History of Changes
Other Study ID Numbers: MI-CP224
Study First Received: March 19, 2010
Last Updated: August 29, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 17, 2014