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

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.

Timeline

Start

2017-12-04

Primary completion

2020-05-11

Completion

2020-05-11

Outcome

Outcome not reported

Stopped (Business): “The program is canceled due to company strategic reasons.”

Publications

• Mou S, Hummer BT, Yuan J, Huang Y, Liang M, Faggioni R, Roskos LK, Rosenbaum AI. Investigations of Enteric-Coated Tablet Propyl Gallate-Induced Nephrotoxicity in Beagles as well as Human and Dog Renal Proximal Tubule Epithelial Cells. ACS Pharmacol Transl Sci. 2025 Apr 4;8(5):1282-1291. doi: 10.1021/acsptsci.4c00563. eCollection 2025 May 9.

Drugs

Indications

No indication recorded.