Safety and Tolerability of MEDI3506 in Healthy Participants, in Participants With COPD and Healthy Japanese Participants

PHASE1CompletedINTERVENTIONAL
Enrollment

88

Participants

Timeline

Start Date

May 15, 2017

Primary Completion Date

September 30, 2019

Study Completion Date

September 30, 2019

Conditions
Part I (SAD) - Healthy ParticipantsPart II (MAD) - Chronic Obstructive Pulmonary DiseasePart III (J-SD) - Healthy Japanese Participants
Interventions
DRUG

MEDI3506

Healthy participants with a history of mild atopy and proven sensitivity to HDM will receive a single MEDI3506 Dose 1 or Dose 2 or Dose 3 or Dose 4 or Dose 5 or Dose 6 subcutaneously and Dose 6 intravenously in Part 1. Participants with COPD will receive 3 administration of MEDI3506 Dose 4 or Dose 5 or Dose 6 subcutaneously two weeks apart over a 4-week dosing period in Part 2. Healthy Japanese participants will receive a single dose of MEDI3506 Dose 6 intravenously in Part 3.

DRUG

Placebo

Healthy participants with a history of mild atopy and proven sensitivity to HDM will receive a single dose of placebo matched to MEDI3506 subcutaneously or intravenously in Part 1. Participants with COPD will receive 3 administration of placebo matched to MEDI3506 subcutaneously two weeks apart over a 4-week dosing period in Part 2. Healthy Japanese participants will receive a single dose of placebo matched to MEDI3506 intravenously in Part 3.

Trial Locations (2)

HA1 3UJ

Research Site, London

M23 9QZ

Research Site, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

MedImmune LLC

INDUSTRY

NCT03096795 - Safety and Tolerability of MEDI3506 in Healthy Participants, in Participants With COPD and Healthy Japanese Participants | Biotech Hunter | Biotech Hunter