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

NCT ID: NCT03362593

Last Updated: 2020-08-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-04
• Study Completion Date: 2020-05-11

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.

Detailed Description

MEDI7219 is being developed for the potential treatment of type 2 diabetes. The study is a first in human, single and multiple ascending dose study that will try to identify the safety, tolerability and pharmacokinetics (how the drug moves through the body) of MEDI7219. The study will also look at the impact of changes to the formulation as well as differences related to the route of administration. The study will consist of 6 parts involving approximately 198 healthy male and female subjects (and up to 146 additional subjects). In Part A, 6 cohorts of 10 subjects each (with an optional 2 cohorts) will be randomized to receive MEDI7219 or one of two placebos. Each cohort will receive a different formulation of the study drug. In part B, a single cohort of 16 subjects (with an optional second cohort) will receive a different formulation of MEDI7219 per period in up to 5 periods. In Part C, up to 12 subjects will be dosed with MEDI7219. In Part D, one cohort of 30 subjects (with an optional second cohort) will be randomized to receive MEDI7219 or placebo. Subjects will start on a dose based on data from previous parts and will receive ascending doses for 35 days. In Part E, 2 cohorts of 6 subjects each (with an optional third & fourth cohort of 12 subjects each) will receive a different formulation of MEDI7219 per period. Part E, cohort 5 12 subjects each period (2 periods) has been added to assess 2 different formulations In Part F, two cohorts of 16 subjects each will be randomized to receive MEDI7219 or placebo. Subjects will start on a dose based on data from previous parts and will receive ascending doses for 35 days.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

MEDI7219

Experimental Drug

Group Type: EXPERIMENTAL

MEDI7219

Intervention Type: DRUG

Experimental Drug

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Formulation without Active Drug

Formulation without Active Drug

Group Type: PLACEBO_COMPARATOR

Formulation without Active Drug

Intervention Type: DRUG

Formulation without Active Drug

Interventions

MEDI7219

Experimental Drug

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Formulation without Active Drug

Formulation without Active Drug

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

MedImmune LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site

Ruddington, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 40370985 (View on PubMed)

Other Identifiers

D8170C00001

Identifier Type: -

Identifier Source: org_study_id