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Phase 1, Single Dose Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of MEDI5884

NCT03001297 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2018-08-22

No results posted yet for this study

Summary

A Phase 1, single dose study with 4 cohorts of ascending doses and an optional Japanese cohort designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of MEDI5884 in healthy volunteers

Conditions

  • Healthy Volunteers

Interventions

BIOLOGICAL

Placebo

Participants will receive single dose of placebo matched MEDI5884 injection SC on Day 1

BIOLOGICAL

MEDI5884 Dose 1

Participants will receive single dose MEDI5884 Dose 1 injection SC on Day 1.

BIOLOGICAL

MEDI5884 Dose 2

Participants will receive single dose MEDI5884 Dose 2 injection SC on Day 1

BIOLOGICAL

MEDI5884 Dose 3

Participants will receive single dose MEDI5884 Dose 3 injection SC on Day 1

BIOLOGICAL

MEDI5884 Dose 4

Participants will receive single dose MEDI5884 Dose 4 injection SC on Day 1

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-17
Primary Completion
2018-08-10
Completion
2018-08-10

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT03001297 on ClinicalTrials.gov