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Phase 1 Randomized Double-blind Placebo Controlled Study to Evaluate Safety and PK of MEDI3902 in Healthy Adults

NCT02255760 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2018-08-13

Study results available
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Summary

This is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation study evaluating the safety and tolerability of a single ascending IV dose of MEDI3902 in healthy adult subjects 18 to 60 years of age.

Conditions

  • MEDI3902 for Prevention of P. Aeruginosa Pneumonia

Interventions

DRUG

MEDI3902 - Dose 1

Participants will receive a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1.

DRUG

MEDI3902 - Dose 2

Participants will receive a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1.

DRUG

MEDI3902 - Dose 3

Participants will receive a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1.

DRUG

MEDI3902 - Dose 4

Participants will received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1.

OTHER

Placebo

Participants will receive a single dose of placebo by IV infusion up to a maximum of 12 hours.

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • Hasan S. Jafri, M.D. · MedImmune LLC

  • Martha Hernandez-Illas, MD · MRA Clinical Research, LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-09-04
Primary Completion
2015-04-20
Completion
2015-04-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT02255760 on ClinicalTrials.gov