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

NCT03096795 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2020-10-05

No results posted yet for this study

Summary

This is a Phase 1, randomised, blinded, placebo controlled, study designed to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity response to single and multiple doses of MEDI3506.

Conditions

  • Part I (SAD) - Healthy Participants
  • Part II (MAD) - Chronic Obstructive Pulmonary Disease
  • Part 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.

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • Muna Albayaty, MBChB, FFPM. MSc · Parexel

  • David Singh, MD · Medicines Evaluation Unit

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-05-15
Primary Completion
2019-09-30
Completion
2019-09-30

Countries

  • United Kingdom

Study Locations

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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 NCT03096795 on ClinicalTrials.gov