CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 56 enrolled
Drug / intervention
MEDI3902 - Dose 1 +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02255760
NCT02255760Phase 1Completed
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A Phase 1 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetics of MEDI3902 in Healthy Adults

MedImmune LLC·interventional·Posted Oct 3, 2014·Updated Aug 13, 2018

In Brief

A Phase 1 clinical trial evaluating MEDI3902 - Dose 1, MEDI3902 - Dose 2, and 3 other interventions for MEDI3902 for Prevention of P. Aeruginosa Pneumonia. Completed, enrolled 56 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMEDI3902 for Prevention of P. Aeruginosa Pneumonia
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 3, 2014
Enrollment StartSep 4, 2014
Primary CompletionApr 20, 2015
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 11.7 years ago

Interventions

MEDI3902 - Dose 1drug

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

MEDI3902 - Dose 2drug

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

MEDI3902 - Dose 3drug

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

MEDI3902 - Dose 4drug

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

Placeboother

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