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
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
- 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
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