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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 20, 2014