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

NCT01913028 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2014-02-12

No results posted yet for this study

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

Interventions

DRUG

MEDI9929

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

DRUG

Placebo

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

Sponsors & Collaborators

  • MedImmune LLC

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Kei Sakamoto, MD, PhD · Kyushu Clinical Pharmacology Research Clinic, Medical Co. LTA

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • Japan

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01913028 on ClinicalTrials.gov