Healthy VolunteersPhase 1NCT03362593

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

A Phase 1 study testing MEDI7219 and Formulation without Active Drug in people with Healthy Volunteers, run by MedImmune LLC at 1 site in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: MEDI7219 and Formulation without Active Drug
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 186 participants
Where: 1 siteUnited Kingdom
Study dates: 4 Dec 2017to 11 May 2020
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Show all 11Show fewer

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)

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Research Site
Ruddington, NG11 6JS

Other trials in United Kingdom

About this study

Official title: A Phase 1 Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MEDI7219 in Healthy Subjects, Including Assessment of the Impact of Changes to the Oral Formulation and Determination of Intravenous Pharmacokinetics

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.

Read the 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
Being tested: MEDI7219, Placebo, Formulation without Active Drug

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MEDI7219Drug
Experimental Drug
PlaceboDrug
Placebo
Formulation without Active DrugDrug
Formulation without Active Drug

Study groups in NCT03362593
Study group	Role	What they receive
MEDI7219	Experimental	Experimental Drug Receives: Drug: MEDI7219
Placebo	Placebo comparator	Placebo Receives: Drug: Placebo
Formulation without Active Drug	Placebo comparator	Formulation without Active Drug Receives: Drug: Formulation without Active Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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
PK parameters will be calculated from the plasma concentration versus time data for Cmax (maximum observed concentration)
Measured: 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
PK parameters will be calculated from the plasma concentration versus time data for Tmax (time to maximum observed concentration)
Measured: 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
PK parameters will be calculated from the plasma concentration versus time data for T1/2 (terminal half-life)
Measured: 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)
PK parameters will be calculated from the plasma concentration versus time data for AUC (0-inf) [area under the curve (AUC) extrapolated to infinity]
Measured: 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)
PK parameters will be calculated from the plasma concentration versus time data for AUC (0-last) [area under the curve (AUC) from time 0 to last measurable concentration]
Measured: 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(0-24h)
PK parameters will be calculated from the plasma concentration versus time data for (AUC 0-24) [area under the curve (AUC) from time 0 to 24 hours post dose]
Measured: 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 (%extrap)
PK parameters will be calculated from the plasma concentration versus time data for AUC%extrapolated [The percentage of AUC(0-inf) accounted for by extrapolation]
Measured: 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)
Pharmacokinetics of MEDI7219: Lambda-z
PK parameters will be calculated from the plasma concentration versus time data for Lambda-z [Slope of the regression line passing through the apparent elimination phase in a concentration vs time plot]
Measured: 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)
Pharmacokinetics of MEDI7219: CL/F
PK parameters will be calculated from the plasma concentration for CL/F (apparent clearance)
Measured: Pre-dose to 144 hours post-dose (Parts A, B and Part E cohorts 1 & 2 only); Pre-dose to 168 hours post-dose (Part E optional cohorts only)
Pharmacokinetics of MEDI7219: Vz/F
PK parameters will be calculated from the plasma concentration for Vz/F (volume of distribution)
Measured: Pre-dose to 144 hours post-dose (Parts A, B and Part E cohorts 1 & 2 only); Pre-dose to 168 hours post-dose (Part E optional cohorts only); Pre-dose to Day 63/EOS visit (Parts D & F)
Pharmacokinetics of MEDI7219: Frel
PK parameters will be calculated from the plasma concentration for Frel (relative bioavailability)
Measured: Pre-dose to 144 hours post-dose (Parts B and Part E cohorts 1 & 2 only); Pre-dose to 168 hours post-dose (Part E optional cohorts only)
Pharmacokinetics of MEDI7219: Vd
PK parameters will be calculated from the plasma concentration for Vd (volume of distribution)
Measured: Pre-dose to 144 hours (Part C)
Pharmacokinetics of MEDI7219: F
PK parameters will be calculated from the plasma concentration for F (absolute bioavailability)
Measured: Pre-dose to 144 hours (Part C )
Pharmacokinetics of MEDI7219: AUC (0-tau)
PK parameters will be calculated from the plasma concentration versus time data for AUC (0-tau) [area under the curve (AUC) for a dosing interval]
Measured: Pre-dose to Day 63/EOS visit (Parts D & F)
Immunogenicity
Presence of Anti-drug antibody to MEDI7219
Measured: Day -1 to Day 28/EOS Visit (Parts A and C); Day -1 to Day 63/EOS Visit (Parts D & F); Day -1 to 28 days post last dose of final period/EOS Visit (Parts B and E)
Pharmacokinetics of Formulation Component: Cmax
PK parameters will be calculated from the plasma concentration versus time data for Cmax (maximum observed concentration)
Measured: Predose to 8 hours post dose Day 1 (Parts A, B and E); Pre-dose to 8 hours post dose on Days 1, 7, 8, 14, 15, 21, 22, 28, 29 and 35 (Part D and F Cohort 1); Pre-dose to 24 hours post dose on Days 1, 14, 28 and 35 (Part F Cohort 2, respectively)
Pharmacokinetics of Formulation Component: Tmax
PK parameters will be calculated from the plasma concentration versus time data for Tmax (time to maximum observed concentration)
Measured: Predose to 8 hours post dose Day 1 (Parts A, B and E); Pre-dose to 8 hours post dose on Days 1, 7, 8, 14, 15, 21, 22, 28, 29 and 35 (Part D and F Cohort 1); Pre-dose to 24 hours post dose on Days 1, 14, 28 and 35 (Part F Cohort 2, respectively)
Pharmacokinetics of Formulation Component: T(1/2)
PK parameters will be calculated from the plasma concentration versus time data for T1/2 (terminal half-life)
Measured: Predose to 8 hours post dose Day 1 (Parts A, B and E); Pre-dose to 8 hours post dose on Days 1, 7, 8, 14, 15, 21, 22, 28, 29 and 35 (Part D and F Cohort 1); Pre-dose to 24 hours post dose on Days 1, 14, 28 and 35 (Part F Cohort 2, respectively)
Pharmacokinetics of Formulation Component: AUC (0-inf)
PK parameters will be calculated from the plasma concentration versus time data for AUC (0-inf) [area under the curve (AUC) extrapolated to infinity]
Measured: Predose to 8 hours post dose Day 1 (Parts A, B and E); Pre-dose to 8 hours post dose on Days 1, 7, 8, 14, 15, 21, 22, 28, 29 and 35 (Part D and F Cohort 1); Pre-dose to 24 hours post dose on Days 1, 14, 28 and 35 (Part F Cohort 2, respectively)
Pharmacokinetics of Formulation Component: AUC (0-last)
PK parameters will be calculated from the plasma concentration versus time data for AUC (0-last) [area under the curve (AUC) from time 0 to last measurable concentration]
Measured: Predose to 8 hours post dose Day 1 (Parts A, B and E); Pre-dose to 8 hours post dose on Days 1, 7, 8, 14, 15, 21, 22, 28, 29 and 35 (Part D and F Cohort 1); Pre-dose to 24 hours post dose on Days 1, 14, 28 and 35 (Part F Cohort 2, respectively)
Pharmacokinetics of Formulation Component: AUC (0-8h)
PK parameters will be calculated from the plasma concentration versus time data for (AUC 0-24) [area under the curve (AUC) from time 0 to 8 hours post dose]
Measured: Predose to 8 hours post dose Day 1 (Parts A, B and E); Pre-dose to 8 hours post dose on Days 1, 7, 8, 14, 15, 21, 22, 28, 29 and 35 (Part D and F Cohort 1); Pre-dose to 24 hours post dose on Days 1, 14, 28 and 35 (Part F Cohort 2, respectively)
Pharmacokinetics of MEDI7219: CL
PK parameters will be calculated from the plasma concentration from CL (apparent clearance)
Measured: Pre-dose to 144 hours post-dose (Part C)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Dec 201711 May 2020

First posted5 Dec 2017
Study start4 Dec 2017
Primary completion11 May 2020
Study completion11 May 2020

Why it stopped: The program is canceled due to company strategic reasons.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 186 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03362593
Sponsor's protocol ID: D8170C00001
Status last verified: Aug 2020
First submitted: 22 Nov 2017
Last updated: 31 Aug 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ standards.

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.
PubMed 40370985

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MEDI7219 in Healthy Subjects, Including Assessment of the Impact of Changes to the Oral Formulation and Determination of Intravenous Pharmacokinetics
ClinicalTrials.gov ID: NCT03362593
Acronym / sponsor ID: D8170C00001
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: The program is canceled due to company strategic reasons.
Enrolment: 186 participants (actual)
Lead sponsor: MedImmune LLCIndustry (pharma, biotech, devices)
Study start: 4 Dec 2017 (actual)
Primary completion: 11 May 2020 (actual)
Study completion: 11 May 2020 (actual)
First posted: 5 Dec 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
MEDI7219	Experimental	Drug: MEDI7219Experimental Drug
Placebo	Placebo comparator	Drug: PlaceboPlacebo
Formulation without Active Drug	Placebo comparator	Drug: Formulation without Active DrugFormulation without Active Drug

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MEDI7219Experimental Drug	Drug	MEDI7219
PlaceboPlacebo	Drug	Placebo
Formulation without Active DrugFormulation without Active Drug	Drug	Formulation without Active Drug

Primary outcome

Number of subjects with Adverse Events as a measure of safety and tolerability of MEDI7219
Time frame: 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)
Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs)

22 secondary outcomes

Pharmacokinetics of MEDI7219: Cmax
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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(0-24h)
Time frame: 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 (%extrap)
Time frame: 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)
Pharmacokinetics of MEDI7219: Lambda-z
Time frame: 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)
Pharmacokinetics of MEDI7219: CL/F
Time frame: Pre-dose to 144 hours post-dose (Parts A, B and Part E cohorts 1 & 2 only); Pre-dose to 168 hours post-dose (Part E optional cohorts only)
Pharmacokinetics of MEDI7219: Vz/F
Time frame: Pre-dose to 144 hours post-dose (Parts A, B and Part E cohorts 1 & 2 only); Pre-dose to 168 hours post-dose (Part E optional cohorts only); Pre-dose to Day 63/EOS visit (Parts D & F)
Pharmacokinetics of MEDI7219: Frel
Time frame: Pre-dose to 144 hours post-dose (Parts B and Part E cohorts 1 & 2 only); Pre-dose to 168 hours post-dose (Part E optional cohorts only)
Pharmacokinetics of MEDI7219: Vd
Time frame: Pre-dose to 144 hours (Part C)
Pharmacokinetics of MEDI7219: F
Time frame: Pre-dose to 144 hours (Part C )
Pharmacokinetics of MEDI7219: AUC (0-tau)
Time frame: Pre-dose to Day 63/EOS visit (Parts D & F)
Immunogenicity
Time frame: Day -1 to Day 28/EOS Visit (Parts A and C); Day -1 to Day 63/EOS Visit (Parts D & F); Day -1 to 28 days post last dose of final period/EOS Visit (Parts B and E)
Pharmacokinetics of Formulation Component: Cmax
Time frame: Predose to 8 hours post dose Day 1 (Parts A, B and E); Pre-dose to 8 hours post dose on Days 1, 7, 8, 14, 15, 21, 22, 28, 29 and 35 (Part D and F Cohort 1); Pre-dose to 24 hours post dose on Days 1, 14, 28 and 35 (Part F Cohort 2, respectively)
Pharmacokinetics of Formulation Component: Tmax
Time frame: Predose to 8 hours post dose Day 1 (Parts A, B and E); Pre-dose to 8 hours post dose on Days 1, 7, 8, 14, 15, 21, 22, 28, 29 and 35 (Part D and F Cohort 1); Pre-dose to 24 hours post dose on Days 1, 14, 28 and 35 (Part F Cohort 2, respectively)
Pharmacokinetics of Formulation Component: T(1/2)
Time frame: Predose to 8 hours post dose Day 1 (Parts A, B and E); Pre-dose to 8 hours post dose on Days 1, 7, 8, 14, 15, 21, 22, 28, 29 and 35 (Part D and F Cohort 1); Pre-dose to 24 hours post dose on Days 1, 14, 28 and 35 (Part F Cohort 2, respectively)
Pharmacokinetics of Formulation Component: AUC (0-inf)
Time frame: Predose to 8 hours post dose Day 1 (Parts A, B and E); Pre-dose to 8 hours post dose on Days 1, 7, 8, 14, 15, 21, 22, 28, 29 and 35 (Part D and F Cohort 1); Pre-dose to 24 hours post dose on Days 1, 14, 28 and 35 (Part F Cohort 2, respectively)
Pharmacokinetics of Formulation Component: AUC (0-last)
Time frame: Predose to 8 hours post dose Day 1 (Parts A, B and E); Pre-dose to 8 hours post dose on Days 1, 7, 8, 14, 15, 21, 22, 28, 29 and 35 (Part D and F Cohort 1); Pre-dose to 24 hours post dose on Days 1, 14, 28 and 35 (Part F Cohort 2, respectively)
Pharmacokinetics of Formulation Component: AUC (0-8h)
Time frame: Predose to 8 hours post dose Day 1 (Parts A, B and E); Pre-dose to 8 hours post dose on Days 1, 7, 8, 14, 15, 21, 22, 28, 29 and 35 (Part D and F Cohort 1); Pre-dose to 24 hours post dose on Days 1, 14, 28 and 35 (Part F Cohort 2, respectively)
Pharmacokinetics of MEDI7219: CL
Time frame: Pre-dose to 144 hours post-dose (Part C)

Results and safety

The study was stopped early (reason given: The program is canceled due to company strategic reasons.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2020.
Derived from this study: PubMed 40370985Mou 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.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ standards.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MEDI7219 and Formulation without Active Drug in people with Healthy Volunteers, run by MedImmune LLC at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 31 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The program is canceled due to company strategic reasons.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of subjects with Adverse Events as a measure of safety and tolerability of MEDI7219 (time frame: 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03362593, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2020.