Healthy VolunteersPhase 1NCT03001297
Phase 1, Single Dose Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of MEDI5884
A Phase 1 study testing MEDI5884 Dose 1, MEDI5884 Dose 2 and MEDI5884 Dose 3 in people with Healthy Volunteers, run by MedImmune LLC at 1 site in United States.
Trial summary
A Phase 1, single dose study with 4 cohorts of ascending doses and an optional Japanese cohort designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of MEDI5884 in healthy volunteers Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- MEDI5884 Dose 1, MEDI5884 Dose 2 and MEDI5884 Dose 3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2017to 10 Aug 2018
- 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 aged 18-55 years
- Must provide written informed consent
- Ability and willingness to adhere to the protocol
- BMI 18-30kg/m2
- Females not of childbearing potential
- Males must practice 2 effective contraceptive measures if sexually active
- Japanese descent for the Japanese cohort
Who cannot join
- Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product
- History or presence of gastrointestinal, renal, or hepatic disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
- Abnormal lab values, physical exam, vital signs
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks prior to dosing
- Positive Hepatitis B, Hepatitis C or HIV test
- Receipt of investigational therapy with 4 months from screening
Show all 11Show fewer
- Current or previous use of systemic corticosteroids 60 days prior to dosing or lipid lowering medications 28 days prior to dosing
- Abnormal ECG
- Recent plasma or blood donation
- Positive drug or alcohol screen.
- Current smoker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Randomized, Blinded, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single-Ascending Doses of MEDI5884 in Healthy Volunteers
A Phase 1, single dose study with 4 cohorts of ascending doses and an optional Japanese cohort designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of MEDI5884 in healthy volunteers
Read the detailed description
This is a first time in human, phase 1, randomized, blinded, placebo-controlled study to evaluate the safety, pharmacokinetics and pharmacodynamics of single ascending subcutaneous doses of MEDI5884 in healthy volunteers (age 18-55). The study consists of 4 cohorts of increasing doses (8 subjects each) and an optional Japanese American cohort (24 subjects) for a total of 56 healthy subjects. The decision whether or not to dose escalate will be based upon data review by the Dose Escalation Committee. Subjects will be randomized 3:1 to MEDI5884 or placebo. Following screening, the study consists of a 3 day inpatient stay and follow up visits. The number of follow up visits depend on the cohort assigned.
- Conditions
- Healthy Volunteers
- Being tested
- Placebo, MEDI5884 Dose 1, MEDI5884 Dose 2, MEDI5884 Dose 3, MEDI5884 Dose 4
- Keywords
- atherosclerosis; acute coronary syndrome; MEDI5884
- Medical subject headings
- Atherosclerosis, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboBiological
Participants will receive single dose of placebo matched MEDI5884 injection SC on Day 1
MEDI5884 Dose 1Biological
Participants will receive single dose MEDI5884 Dose 1 injection SC on Day 1.
MEDI5884 Dose 2Biological
Participants will receive single dose MEDI5884 Dose 2 injection SC on Day 1
MEDI5884 Dose 3Biological
Participants will receive single dose MEDI5884 Dose 3 injection SC on Day 1
MEDI5884 Dose 4Biological
Participants will receive single dose MEDI5884 Dose 4 injection SC on Day 1
| Study group | Role | What they receive |
|---|---|---|
| MEDI5884 Dose 1 | Experimental | Participants will receive single dose of MEDI5884 Dose 1 injection SC on Day 1. Receives: Biological: MEDI5884 Dose 1 |
| Placebo | Placebo comparator | Placebo will be administered subcutaneously (SC). Receives: Biological: Placebo |
| MEDI5884 Dose 2 | Experimental | Participants will receive single dose of MEDI5884 Dose 2 injection SC on Day 1. Receives: Biological: MEDI5884 Dose 2 |
| MEDI5884 Dose 3 | Experimental | Participants will receive single dose of MEDI5884 Dose 3 injection SC on Day 1. Receives: Biological: MEDI5884 Dose 3 |
| MEDI5884 Dose 4 | Experimental | Participants will receive single dose of MEDI5884 Dose 4 injection SC on Day 1. Receives: Biological: MEDI5884 Dose 4 |
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 MEDI5884
Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs)
Measured: Baseline until last follow-up visit, assessed up to 90 days post dose depending on cohort.
Number of subjects with adverse events as a measure of safety and tolerability of MEDI5884
12 lead electrocardiogram (ECG) including RR (The time between corresponding points on 2 consecutive R waves on ECG), PR (ECG interval measured from the onset of the P wave to the onset of the QRS complex) , QRS (ECG interval measured from the onset of the QRS complex to the J point) , QT (ECG interval measured from the onset of the QRS complex to the end of the T wave), and QTc (QT interval corrected for heart rate) intervals
Measured: Baseline until last follow-up visit, assessed up to 90 days post dose depending on cohort.
Number of subjects with adverse events as a measure of safety and tolerability of MEDI5884
Vital signs (systolic and diastolic blood pressure, pulse rate, temperature, and respiratory rates)
Measured: Baseline until last follow-up visit, assessed up to 90 days post dose depending on cohort.
Number of subjects with adverse events as a measure of safety and tolerability of MEDI5884
Clinical laboratory assessments (serum chemistry, hematology, and urinalysis)
Measured: Baseline until last follow-up visit, assessed up to 90 days post dose depending on cohort.
HDL-Cholesterol over time
HDL-Cholesterol over time
Measured: Baseline until last follow-up visit, assessed up to 90 days post dose depending on cohort.
Secondary outcomes (14)
Lipoprotein particle size
Lipoprotein particle size
Measured: Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing
Lipoprotein particle number
Lipoprotein particle number
Measured: Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing
Levels of total cholesterol
Levels of total cholesterol
Measured: Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing
Non-HDL-Cholesterol
Non-HDL-Cholesterol
Measured: Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing
Low-density lipoprotein cholesterol (direct and Friedewald equation)
Low-density lipoprotein cholesterol (direct and Friedewald equation)
Measured: Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing
Very low-density lipoprotein cholesterol
Very low-density lipoprotein cholesterol
Measured: Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing
Triglycerides
Triglycerides
Measured: Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing
Apolipoprotein B
Apolipoprotein B
Measured: Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing
Apolipoprotein A1
Apolipoprotein A1
Measured: Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing
MEDI5884 serum concentration: maximum observed concentration
MEDI5884 serum concentration: maximum observed concentration
Measured: Post dose on Days 1, 2, 3, 7, 14, 21, 28, 45 (cohorts 2-4 and Japanese American), 60 (cohorts 3, 4 and Japanese American), 75 (cohort 4), and 90 (cohort 4)
MEDI5884 serum concentration: time to maximum observed concentration
MEDI5884 serum concentration:
time to maximum observed concentration
Measured: Post dose on Days 1, 2, 3, 7, 14, 21, 28, 45 (cohorts 2-4 and Japanese American), 60 (cohorts 3, 4 and Japanese American), 75 (cohort 4), and 90 (cohort 4)
MEDI5884 serum concentration: area under the concentration time curve
MEDI5884 serum concentration: area under the concentration time curve
Measured: Post dose on Days 1, 2, 3, 7, 14, 21, 28, 45 (cohorts 2-4 and Japanese American), 60 (cohorts 3, 4 and Japanese American), 75 (cohort 4), and 90 (cohort 4)
MEDI5884 serum concentration: terminal half-life
MEDI5884 serum concentration:
terminal half-life
Measured: Post dose on Days 1, 2, 3, 7, 14, 21, 28, 45 (cohorts 2-4 and Japanese American), 60 (cohorts 3, 4 and Japanese American), 75 (cohort 4), and 90 (cohort 4)
Anti-drug antibody
Anti-drug antibody
Measured: Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2016 (estimated)
- Study start17 Jan 2017
- Primary completion10 Aug 2018
- Study completion10 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03001297
- Sponsor's protocol ID
- D7870C00001
- Status last verified
- Aug 2018
- First submitted
- 23 Nov 2016
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Blinded, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single-Ascending Doses of MEDI5884 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03001297
- Acronym / sponsor ID
- D7870C00001
- Conditions
- Healthy Volunteers
- Keywords
- atherosclerosis; acute coronary syndrome; MEDI5884
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- 17 Jan 2017 (actual)
- Primary completion
- 10 Aug 2018 (actual)
- Study completion
- 10 Aug 2018 (actual)
- First posted
- 23 Dec 2016 (estimated)
- 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.
A Phase 1, single dose study with 4 cohorts of ascending doses and an optional Japanese cohort designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of MEDI5884 in healthy volunteers
Detailed description
This is a first time in human, phase 1, randomized, blinded, placebo-controlled study to evaluate the safety, pharmacokinetics and pharmacodynamics of single ascending subcutaneous doses of MEDI5884 in healthy volunteers (age 18-55). The study consists of 4 cohorts of increasing doses (8 subjects each) and an optional Japanese American cohort (24 subjects) for a total of 56 healthy subjects. The decision whether or not to dose escalate will be based upon data review by the Dose Escalation Committee. Subjects will be randomized 3:1 to MEDI5884 or placebo. Following screening, the study consists of a 3 day inpatient stay and follow up visits. The number of follow up visits depend on the cohort assigned.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| MEDI5884 Dose 1 | Experimental | Biological: MEDI5884 Dose 1Participants will receive single dose of MEDI5884 Dose 1 injection SC on Day 1. |
| Placebo | Placebo comparator | Biological: PlaceboPlacebo will be administered subcutaneously (SC). |
| MEDI5884 Dose 2 | Experimental | Biological: MEDI5884 Dose 2Participants will receive single dose of MEDI5884 Dose 2 injection SC on Day 1. |
| MEDI5884 Dose 3 | Experimental | Biological: MEDI5884 Dose 3Participants will receive single dose of MEDI5884 Dose 3 injection SC on Day 1. |
| MEDI5884 Dose 4 | Experimental | Biological: MEDI5884 Dose 4Participants will receive single dose of MEDI5884 Dose 4 injection SC on Day 1. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy volunteers aged 18-55 years
- Must provide written informed consent
- Ability and willingness to adhere to the protocol
- BMI 18-30kg/m2
- Females not of childbearing potential
Key exclusion criteria (11 listed)
- Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product
- History or presence of gastrointestinal, renal, or hepatic disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
- Abnormal lab values, physical exam, vital signs
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks prior to dosing
- Positive Hepatitis B, Hepatitis C or HIV test
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 |
|---|---|---|
| PlaceboParticipants will receive single dose of placebo matched MEDI5884 injection SC on Day 1 | Biological | Placebo |
| MEDI5884 Dose 1Participants will receive single dose MEDI5884 Dose 1 injection SC on Day 1. | Biological | MEDI5884 Dose 1 |
| MEDI5884 Dose 2Participants will receive single dose MEDI5884 Dose 2 injection SC on Day 1 | Biological | MEDI5884 Dose 2 |
| MEDI5884 Dose 3Participants will receive single dose MEDI5884 Dose 3 injection SC on Day 1 | Biological | MEDI5884 Dose 3 |
| MEDI5884 Dose 4Participants will receive single dose MEDI5884 Dose 4 injection SC on Day 1 | Biological | MEDI5884 Dose 4 |
Primary outcome
Number of subjects with adverse events as a measure of safety and tolerability of MEDI5884
Time frame: Baseline until last follow-up visit, assessed up to 90 days post dose depending on cohort.
Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs)
Number of subjects with adverse events as a measure of safety and tolerability of MEDI5884
Time frame: Baseline until last follow-up visit, assessed up to 90 days post dose depending on cohort.
12 lead electrocardiogram (ECG) including RR (The time between corresponding points on 2 consecutive R waves on ECG), PR (ECG interval measured from the onset of the P wave to the onset of the QRS complex) , QRS (ECG interval measured from the onset of the QRS complex to the J point) , QT (ECG interval measured from the onset of the QRS complex to the end of the T wave), and QTc (QT interval corrected for heart rate) intervals
Number of subjects with adverse events as a measure of safety and tolerability of MEDI5884
Time frame: Baseline until last follow-up visit, assessed up to 90 days post dose depending on cohort.
Vital signs (systolic and diastolic blood pressure, pulse rate, temperature, and respiratory rates)
Number of subjects with adverse events as a measure of safety and tolerability of MEDI5884
Time frame: Baseline until last follow-up visit, assessed up to 90 days post dose depending on cohort.
Clinical laboratory assessments (serum chemistry, hematology, and urinalysis)
HDL-Cholesterol over time
Time frame: Baseline until last follow-up visit, assessed up to 90 days post dose depending on cohort.
HDL-Cholesterol over time
14 secondary outcomes
Lipoprotein particle size
Time frame: Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing
Lipoprotein particle number
Time frame: Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing
Levels of total cholesterol
Time frame: Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing
Non-HDL-Cholesterol
Time frame: Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing
Low-density lipoprotein cholesterol (direct and Friedewald equation)
Time frame: Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing
Very low-density lipoprotein cholesterol
Time frame: Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing
Triglycerides
Time frame: Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing
Apolipoprotein B
Time frame: Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing
Apolipoprotein A1
Time frame: Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing
MEDI5884 serum concentration: maximum observed concentration
Time frame: Post dose on Days 1, 2, 3, 7, 14, 21, 28, 45 (cohorts 2-4 and Japanese American), 60 (cohorts 3, 4 and Japanese American), 75 (cohort 4), and 90 (cohort 4)
MEDI5884 serum concentration: time to maximum observed concentration
Time frame: Post dose on Days 1, 2, 3, 7, 14, 21, 28, 45 (cohorts 2-4 and Japanese American), 60 (cohorts 3, 4 and Japanese American), 75 (cohort 4), and 90 (cohort 4)
MEDI5884 serum concentration: area under the concentration time curve
Time frame: Post dose on Days 1, 2, 3, 7, 14, 21, 28, 45 (cohorts 2-4 and Japanese American), 60 (cohorts 3, 4 and Japanese American), 75 (cohort 4), and 90 (cohort 4)
MEDI5884 serum concentration: terminal half-life
Time frame: Post dose on Days 1, 2, 3, 7, 14, 21, 28, 45 (cohorts 2-4 and Japanese American), 60 (cohorts 3, 4 and Japanese American), 75 (cohort 4), and 90 (cohort 4)
Anti-drug antibody
Time frame: Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
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Irritability
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 MEDI5884 Dose 1, MEDI5884 Dose 2 and MEDI5884 Dose 3 in people with Healthy Volunteers, run by MedImmune LLC at 1 site in United States.
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 7 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: finished, as of the sponsor's last update on 22 Aug 2018. 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 States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 MEDI5884 (time frame: Baseline until last follow-up visit, assessed up to 90 days post dose depending on cohort.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2018.