Conditions: MEDI3902 for Prevention of P. Aeruginosa Pneumonia
Keywords: MEDI3902 Safety, Pharmacokinetics, Healthy Volunteers
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 56
Healthy volunteers: yes

Brief 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.

Detailed description:
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. Approximately 40 subjects will be enrolled across 4 fixed dose cohorts at 1 study site. This study will last approximately 90 days, constituting a screening period of up to 28 days, 1 day of investigational product administration, and a 60 day safety follow up period.

Arms:
arm 1: Participants will receive a single intravenous (IV) dose of MEDI3902 infused for a minimum of 13 minutes on Day 1. arm 2: Participants will receive a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1. arm 3: Participants will receive a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1. arm 4: Participants will received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1. arm 5: Participants will receive a single dose of placebo by IV infusion up to a maximum of 12 hours.

Interventions: intervention 1: MEDI3902 - Dose 1 intervention 2: MEDI3902 - Dose 2 intervention 3: MEDI3902 - Dose 3 intervention 4: MEDI3902 - Dose 4 intervention 5: Placebo
Intervention descriptions: intervention 1: Participants will receive a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1. intervention 2: Participants will receive a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1. intervention 3: Participants will receive a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1. intervention 4: Participants will received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1. intervention 5: Participants will receive a single dose of placebo by IV infusion up to a maximum of 12 hours.

Protocol document: