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 | Terminated Phase 1

• 1 other identifier: D8170C00001
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number of subjects with Adverse Events as a measure of safety and tolerability of MEDI7219

  Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs)

  Baseline to last follow up visit (Parts A and C - Day 28) (Part D & F Day 63) and (Parts B and E 28 days post last dose)

Secondary Outcomes (22)

• Pharmacokinetics of MEDI7219: Cmax

  Pre-dose to 144 hours post-dose (Parts A, B, C and Part E cohorts 1 & 2 only); Pre-dose to 168 hours post-dose (Part E optional cohorts only); Parts D & F pre-dose to Day 63/EOS visit

• Pharmacokinetics of MEDI7219: Tmax

  Pre-dose to 144 hours post-dose (Parts A, B, C and Part E cohorts 1 & 2 only); Pre-dose to 168 hours post-dose (Part E optional cohorts only); Parts D & F pre-dose to Day 63/EOS visit, Parts F cohort 2 ONLY: Pre-dose and 8 hours post-dose

• Pharmacokinetics of MEDI7219: t1/2

  Pre-dose to 144 hours post-dose (Parts A, B, C and Part E cohorts 1 & 2 only); Pre-dose to 168 hours post-dose (Part E optional cohorts only); Parts D & F pre-dose to Day 63/EOS visit

• Pharmacokinetics of MEDI7219: AUC (0-inf)

  Pre-dose to 144 hours post-dose (Parts A, B, C and Part E cohorts 1 & 2 only); Pre-dose to 168 hours post-dose (Part E optional cohorts only); Parts D & F pre-dose to Day 63/EOS visit

• Pharmacokinetics of MEDI7219: AUC(0-last)

  Pre-dose to 144 hours post-dose (Parts A, B, C and Part E cohorts 1 & 2 only); Pre-dose to 168 hours post-dose (Part E optional cohorts only); Parts D & F pre-dose to Day 63/EOS visit

Study Arms (3)

MEDI7219

EXPERIMENTAL

Experimental Drug

Drug: MEDI7219

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Formulation without Active Drug

PLACEBO COMPARATOR

Formulation without Active Drug

Drug: Formulation without Active Drug

Interventions

MEDI7219 DRUG

Experimental Drug

MEDI7219

Placebo DRUG

Placebo

Placebo

Formulation without Active Drug DRUG

Formulation without Active Drug

Formulation without Active Drug

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers age 18-55 years
• BMI 18-32 kg/m2
• Females not of childbearing potential
• Able and willing to adhere to the protocol
• Must provide written informed consent

You may not qualify if:

• Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product
• Abnormal lab values, physical exam, vital signs
• Positive drug or alcohol screen.
• Current enrollment in another clinical study or enrollment within the past 3 months
• Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks prior to dosing
• Abnormal ECG
• Positive Hepatitis B, Hepatitis C or HIV test
• Positive Drug or Alcohol screen
• Current smokers or those who have smoked within the last 12 months
• Recent plasma or blood donation
• Evidence of current SARS-CoV-2 infection (Part E Cohort 5 and Part F Cohort 2 only)

Sponsors & Collaborators

• MedImmune LLC: lead

Study Sites (1)

Research Site

Ruddington, NG11 6JS, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 40370985 DERIVED

MeSH Terms

Interventions

MEDI7219; Dosage Forms

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2017
• First Posted: December 5, 2017
• Study Start: December 4, 2017
• Primary Completion: May 11, 2020
• Study Completion: May 11, 2020
• Last Updated: August 31, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access.

Locations

GB (1)