Status:
COMPLETED
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of MEDI9929 After Single Administration in Healthy Male Japanese Subjects
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
MedImmune LLC
Conditions:
Healthy
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess safety, tolerability, pharmacokinetics and immunogenicity of MEDI9929 following administration of single ascending doses in healthy male Japanese subjects.
Detailed Description
This is a Phase I, single centre, randomised, single-blind, placebo-controlled, single ascending dose parallel study in healthy male Japanese subjects. Up to 3 dose levels of MEDI9929 will be investig...
Eligibility Criteria
Inclusion
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Healthy Japanese male subjects aged 20 - 45 years age with a body mass index(BMI) between 18 - 27 kg/m2 at the time of screening
- Sterilized males must be at least 1-year post vasectomy or non-sterilized males who are sexually active with a female partner of childbearing potential must use a highly effective method of contraception from Day 1 through Day 85 (through Day 113 for cohort 3); It is highly recommended for both partners to use contraception, preferably one hormonal or intrauterine device (females) and one barrier method (males).
- Were men who agree to use birth control for 4 months after the last dose of investigational product and to not donate sperm for 4 months after the last dose of investigational product
- Able to comply with the requirements of the protocol
Exclusion
- Had history or evidence of a clinically significant disorder, condition, or disease (including cardiopulmonary, oncologic, immunologic, autoimmune, collagen vascular, renal, metabolic, hematologic, or psychiatric), that in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion
- Any acute illness in the 14 days before Day 1
- Had evidence of any active or suspected bacterial, viral, fungal, or parasitic infections within the past 30 days before randomization (eg, common cold, viral syndrome, flu-like symptoms), or a high risk, in the opinion of the investigator, for parasitic disease
- Clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, hematology or urinalysis as judged by the investigator
- Has a history of anaphylaxis to another therapeutic monoclonal antibody or biologic therapy
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT01913028
Start Date
August 1 2013
End Date
January 1 2014
Last Update
February 12 2014
Active Locations (2)
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1
Kyushu Clinical Pharmacology Research Clinic, Medical Co. LTA
Fukuoka, Hakata, Japan, 810-0064
2
Research Site
Fukuoka, Japan