A 6-Part Study In Healthy Volunteers To Evaluate Safety, Tolerability and Uptake Of MEDI7219 in the Body When Given as Single and Multiple Doses

NCT03362593 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2020-08-31

No results posted yet for this study

Summary

This is a 6-part study to evaluate the safety, tolerability, and PK of MEDI7219 in healthy subjects. Parts A, B, C \& E are the single-dose parts of the study. Parts D \& F are the multiple ascending dose (MAD) parts of the study. The starting dose and formulation for Parts D \& F will be selected from data emerging from Parts A, B and E. Enrollment of approximately 198 subjects is anticipated.

Conditions

  • Healthy Volunteers

Interventions

DRUG

MEDI7219

Experimental Drug

DRUG

Placebo

Placebo

DRUG

Formulation without Active Drug

Formulation without Active Drug

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-12-04
Primary Completion
2020-05-11
Completion
2020-05-11

Countries

  • United Kingdom

Study Locations

More Related Trials

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 NCT03362593 on ClinicalTrials.gov