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NCT03362593

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

Terminated Phase 1 Last updated 31 August 2020
What this trial tests

Phase 1 trial testing MEDI7219 in Healthy Volunteers in 186 participants. Terminated before completion.

Timeline
4 December 2017
Primary endpoint
11 May 2020
11 May 2020

Quick facts

Lead sponsorMedImmune LLC
PhasePhase 1
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment186
Start date4 December 2017
Primary completion11 May 2020
Estimated completion11 May 2020
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

MedImmune LLC — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Systems Biology and Peptide Engineering to Overcome Absorption Barriers for Oral Peptide Delivery: Dosage Form Optimization Case Study Preceding Clinical Translation.
    Tyagi P, Patel C, Gibson K, MacDougall F, et al · · 2023 · cited 6× · PMID 37896196 · DOI 10.3390/pharmaceutics15102436
  2. Investigations of Enteric-Coated Tablet Propyl Gallate-Induced Nephrotoxicity in Beagles as well as Human and Dog Renal Proximal Tubule Epithelial Cells.
    Mou S, Hummer BT, Yuan J, Huang Y, et al · · 2025 · PMID 40370985 · DOI 10.1021/acsptsci.4c00563

Verify or expand the search:

Other recruiting trials for Healthy Volunteers

Currently open trials in the same condition.

Other MedImmune LLC trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03362593.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing