A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of MEDI9929 After Single Administration in Healthy Male Japanese Subjects

NCT01913028 | Completed Phase 1

• 1 other identifier: D5180C00003
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy

Keywords

safety, tolerability, pharmacokinetics,immunogenicity, MEDI9929, Japanese

Outcome Measures

Primary Outcomes (1)

• Description of the Safety and tolerability profile of MEDI9929

  To investigate the safety and tolerability (Adverse events, blood pressure and pulse, Electrocardiogram, Body temperature, respiratory rate, Haematology, Clinical Chemistry, Urinalysis, and physical examination) of MEDI9929 following administration of single ascending doses.

  84 days for cohort 1/2, 112 days for cohort 3

Secondary Outcomes (2)

• Description of Pharmacokinetics profile for MEDI9929

  84 days for cohort 1/2, 112 days for cohort 3

• Description of Immunogenicity profile for MEDI9929

  84 days for cohort 1/2, 112 days for cohort 3

Study Arms (2)

MEDI9929

EXPERIMENTAL

Solution of MEDI9929, SC

Drug: MEDI9929

Placebo

PLACEBO COMPARATOR

Placebo solution for MEDI9929, SC

Drug: Placebo

Interventions

MEDI9929 DRUG

1st cohort : Dose 1 MEDI9929 or placebo 2nd cohort : Dose 2 MEDI9929 or placebo 3rd cohort : Dose 3 MEDI9929 or placebo

MEDI9929

Placebo DRUG

1st cohort : Dose 1 MEDI9929 or placebo 2nd cohort : Dose 2 MEDI9929 or placebo 3rd cohort : Dose 3 MEDI9929 or placebo

Placebo

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead
• MedImmune LLC: collaborator

Study Sites (2)

Kyushu Clinical Pharmacology Research Clinic, Medical Co. LTA

Fukuoka, Hakata, 810-0064, Japan

Location

Research Site

Fukuoka, Japan

Location

MeSH Terms

Interventions

tezepelumab

Study Officials

• Kei Sakamoto, MD, PhD

  Kyushu Clinical Pharmacology Research Clinic, Medical Co. LTA

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 30, 2013
• First Posted: July 31, 2013
• Study Start: August 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: February 12, 2014

Record last verified: 2014-02

Locations

JP (2)