SafetyPhase 1NCT03385369
A Study to Evaluate the Safety and Pharmacokinetics of MEDI0382 in Overweight/Obese Subjects of Japanese or Chinese Descent
A Phase 1 study testing MEDI0382 in people with Safety and Healthy Subjects, run by MedImmune LLC at 1 site in United States.
Trial summary
This is a phase I, randomized, blinded study to evaluate the safety and pharmacokinetics of MEDI0382 following single dose administration to overweight/obese subjects of Japanese or Chinese descent Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety, Healthy Subjects
- What is being tested?
- MEDI0382
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2018to 12 Apr 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following criteria:
- Healthy subjects age 18 to 65 years inclusive at the time of consent.
- Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act in the USA), obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
- Female subjects of childbearing potential must have a negative serum or urine pregnancy test at screening and randomization, and must not be lactating.
- Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception from screening and must agree to continue using such precautions through to the end of the study. It is strongly recommended for the male partner of a female subject to also use male condom plus spermicide throughout this period. Cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.
- Subject has a body weight ≥ 50 kg (110 lbs) and a BMI ≥ 23 and ≤ 40 kg/m2 inclusive.
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- Venous access suitable for multiple cannulations.
- Part A only:
- Subject is a native of Japan or a Japanese American; defined as having both parents and four grandparents who are Japanese. This includes second and third generation subjects of Japanese descent whose parents or grandparents are living in a country other than Japan.
- Part B only:
- 8. Subject is a native of China or a Chinese American; defined as having both parents and four grandparents who are Chinese. This includes second and third generation subjects of Chinese descent whose parents or grandparents are living in a country other than China.
Who cannot join
- Any of the following would exclude the subject from participation in the study:
- Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results. Specific examples are:
- Past history of acute or chronic pancreatitis, or pancreatic amylase or lipase greater than twice the upper limit of normal (ULN) at screening.
- Past history of gastroparesis requiring treatment.
- Past history of surgery affecting the upper GI tract likely to affect the interpretation of safety and tolerability data.
- History of cholelithiasis leading to episodes of acute cholecystitis not treated by cholecystectomy, or known biliary disease.
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- History of or family history of multiple endocrine neoplasia type 2; or serum calcitonin suggestive of thyroid C-cell hyperplasia (calcitonin level > 50 ng/L); or medullary thyroid carcinoma at screening.
- Past history of clinically significant cardiac rhythm disturbance (eg, permanent or paroxysmal atrial fibrillation/flutter, paroxysmal supraventricular tachycardia, paroxysmal ventricular tachycardia, presence of an implantable pacemaker device or cardioverter/defibrillator).
- History of treated or symptomatic cardiac failure.
- Impaired renal function, defined as estimated glomerular filtration rate < 60 mL/minute/1.73 m2 at screening.
- History of previous myocardial infarction or cerebrovascular accident (eg, stroke).
- History or presence of GI, renal, or hepatic disease (with the exception of Gilbert's syndrome), or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- History of cancer, with the exception of non-melanoma skin cancer.
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks prior to dosing.
- Positive hepatitis B surface antigen or hepatitis C virus antibody serology at screening.
- Positive human immunodeficiency virus test at screening or use of antiretroviral medications as determined by medical history or subject's verbal report.
- Any of the following based on screening blood tests:
- Aspartate aminotransferase (AST) ≥ 1.5 × ULN.
- Alanine aminotransferase (ALT) ≥ 1.5 × ULN.
- Total bilirubin ≥ 1.5 × ULN.
- Hemoglobin below 12 g/dL.
- Neutrophils < 1.5 × 10^9/L.
- Thyroid stimulating hormone level above the normal range.
- Use of any of the following medicinal products:
- Concurrent or previous use of a GLP-1 receptor agonist.
- Current or previous use of systemic corticosteroids within the past 28 days prior to screening.
- Use of any licensed medicinal products, or herbal preparations for control of body weight or appetite, is prohibited from one week prior to Day -1 through Day 3.
- Abnormal vital signs after 10 minutes of supine rest, defined as any of the following:
- Systolic BP < 90 mmHg or ≥ 140 mmHg.
- Diastolic BP < 50 mmHg or ≥ 90 mmHg.
- Heart rate < 45 or > 85 beats per minute.
- Any clinically important abnormalities in rhythm, conduction (eg, Wolff-Parkinson-White syndrome, sick-sinus syndrome), or morphology of the resting 12-lead ECG, or any abnormalities in the ECG that, in the opinion of the investigator, may interfere with the interpretation of changes in the QTc, including abnormal T-wave morphology, or left ventricular hypertrophy.
- Prolonged QTc using the Fridericia formula (QTcF) > 450 milliseconds, or shortened QTcF < 340 milliseconds based on 12-lead ECG, or family history of long QT syndrome.
- PR (PQ) interval shortening < 120 milliseconds (PR < 120 but > 110 milliseconds is acceptable if there is no evidence of ventricular pre excitation).
- PR (PQ) interval prolongation (> 240 milliseconds), intermittent second degree block (Wenckebach block while asleep is not exclusive) or third degree block, or atrioventricular dissociation.
- Complete or intermittent complete bundle branch block, incomplete bundle branch block,or intraventricular conduction delay with QRS > 110 milliseconds. Subjects with QRS > 110 but < 115 milliseconds are acceptable if there is no evidence of ventricular hypertrophy.
- Known or suspected history of drug abuse within the past 3 years as judged by the investigator.
- History of alcohol abuse or excessive intake of alcohol within the past 3 years as judged by the investigator.
- Positive screen for drugs of abuse or positive breath test for alcohol at screening. Subjects who use benzodiazepines for chronic anxiety or sleep disorders may be permitted to enter the study.
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity as judged by the investigator.
- Whole blood or red blood cell donation, or any blood loss > 500 mL within 2 months prior to screening.
- Receipt of another new chemical entity (defined as a compound that has not been approved for marketing), or participation in any other clinical study that included drug treatment within at least 30 days or 5 half-lives of the administration of investigational product in this study (whichever is longer). The period of exclusion will end 30 days or 5 half-lives of investigational product after the final dose, whichever is longest. Subjects consented and screened, but not randomized into this study or a previous study, will not be excluded.
- Psychiatric illness such that subjects have been committed to an institution by way of official or judicial order.
- The subject is an employee, or close relative of an employee, of AstraZeneca, MedImmune, the CRO, or the study site, regardless of the employee's role.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Blinded, Single Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of MEDI0382 in Overweight/Obese Subjects of Japanese or Chinese Descent
This is a phase I, randomized, blinded study to evaluate the safety and pharmacokinetics of MEDI0382 following single dose administration to overweight/obese subjects of Japanese or Chinese descent
Read the detailed description
This is a phase I, randomized, blinded study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of MEDI0382 following single dose administration to overweight/obese but otherwise healthy adult male and female subjects of Japanese or Chinese descent
- Conditions
- Safety, Healthy Subjects
- Being tested
- MEDI0382, Placebo
- Keywords
- MEDI0382, Safety, Tolerability, Pharmacokinetics, Immunogenicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI0382Drug
Single dose of MEDI0382
PlaceboDrug
Single dose of placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo Japanese Descent | Placebo comparator | Participants of Japanese descent will receive a single subcutaneous injection of placebo matching to MEDI0382. Receives: Drug: Placebo |
| MEDI0382 50 mcg Japanese Descent | Experimental | Participants of Japanese descent will receive a single subcutaneous dose of 50 mcg MEDI0382. Receives: Drug: MEDI0382 |
| MEDI0382 100 mcg Japanese Descent | Experimental | Participants of Japanese descent will receive a single subcutaneous dose of 100 mcg MEDI0382. Receives: Drug: MEDI0382 |
| MEDI0382 150 mcg Japanese Descent | Experimental | Participants of Japanese descent will receive a single subcutaneous dose of 150 mcg MEDI0382. Receives: Drug: MEDI0382 |
| Placebo Chinese Descent | Experimental | Participants of Chinese descent will receive a single subcutaneous injection of placebo matching to MEDI0382. Receives: Drug: Placebo |
| MEDI0382 100 mcg Chinese Descent | Experimental | Participants of Chinese descent will receive a single subcutaneous dose of 100 mcg MEDI0382. Receives: Drug: MEDI0382 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug and up to Day 29.
Measured: Day 1 through Day 29
Number of Participants With Treatment Emergent Adverse Events of Special Interest (AESIs)
An AESI (serious or non-serious) was one of scientific and medical interest specific to understanding of study drug and may have required close monitoring and rapid communication by investigator to the sponsor.
Measured: Day 1 through Day 29
Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs
Number of participants with TEAEs related to clinically significant ECG abnormalities are reported.
Measured: Day 1 through Day 29
Number of Participants With Vital Signs Abnormalities Reported as TEAEs
Number of participants with TEAEs related to vital sign abnormalities are reported.
Measured: Day 1 through Day 29
Number of Participants With Abnormal Laboratory parameters Reported as TEAEs
Number of participants with TEAEs related to clinically significant abnormal laboratory parameter are reported.
Measured: Day 1 through Day 29
Secondary outcomes (7)
Number of Participants With Postive Anti-Drug Antibodies (ADA) Titer to MEDI0382
The number of participants with positive serum antibodies to MEDI0382 are reported.
Measured: Baseline (Day-1), Day 8, and Day 29
Maximum Observed Plasma Concentration (Cmax) of MEDI0382
Measured: Pre dose; and at 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI0382
Measured: Pre dose; and at 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose
Area Under the Concentration-time Curve From Time Zero to Last Time of Quantifiable Concentration (AUC0 last) of MEDI0382
Measured: Pre dose; and at 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose
Time to Maximum Observed Plasma Concentration (tmax) of MEDI0382
Measured: Pre dose; and at 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose
Apparent Terminal Elimination Half-life (t1/2) of MEDI0382
Measured: Pre dose; and at 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose
Apparent Clearance (CL/F) of MEDI0382
Measured: Pre dose; and at 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2017
- Study start5 Jan 2018
- Primary completion12 Apr 2018
- Study completion12 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SafetyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter J Winkle, MD, FACP, FACG, CPI, Principal investigator, Anaheim Clinical Trials LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03385369
- Sponsor's protocol ID
- D5670C00012
- Status last verified
- Apr 2019
- First submitted
- 29 Nov 2017
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Blinded, Single Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of MEDI0382 in Overweight/Obese Subjects of Japanese or Chinese Descent
- ClinicalTrials.gov ID
- NCT03385369
- Acronym / sponsor ID
- D5670C00012
- Conditions
- Safety, Healthy Subjects
- Keywords
- MEDI0382, Safety, Tolerability, Pharmacokinetics, Immunogenicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- 5 Jan 2018 (actual)
- Primary completion
- 12 Apr 2018 (actual)
- Study completion
- 12 Apr 2018 (actual)
- First posted
- 28 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.
This is a phase I, randomized, blinded study to evaluate the safety and pharmacokinetics of MEDI0382 following single dose administration to overweight/obese subjects of Japanese or Chinese descent
Detailed description
This is a phase I, randomized, blinded study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of MEDI0382 following single dose administration to overweight/obese but otherwise healthy adult male and female subjects of Japanese or Chinese descent
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo Japanese Descent | Placebo comparator | Drug: PlaceboParticipants of Japanese descent will receive a single subcutaneous injection of placebo matching to MEDI0382. |
| MEDI0382 50 mcg Japanese Descent | Experimental | Drug: MEDI0382Participants of Japanese descent will receive a single subcutaneous dose of 50 mcg MEDI0382. |
| MEDI0382 100 mcg Japanese Descent | Experimental | Drug: MEDI0382Participants of Japanese descent will receive a single subcutaneous dose of 100 mcg MEDI0382. |
| MEDI0382 150 mcg Japanese Descent | Experimental | Drug: MEDI0382Participants of Japanese descent will receive a single subcutaneous dose of 150 mcg MEDI0382. |
| Placebo Chinese Descent | Experimental | Drug: PlaceboParticipants of Chinese descent will receive a single subcutaneous injection of placebo matching to MEDI0382. |
| MEDI0382 100 mcg Chinese Descent | Experimental | Drug: MEDI0382Participants of Chinese descent will receive a single subcutaneous dose of 100 mcg MEDI0382. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Healthy subjects age 18 to 65 years inclusive at the time of consent.
- Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act in the USA), obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
- Female subjects of childbearing potential must have a negative serum or urine pregnancy test at screening and randomization, and must not be lactating.
- Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception from screening and must agree to continue using such precautions through to the end of the study. It is strongly recommended for the male partner of a female subject to also use male condom plus spermicide throughout this period. Cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.
- Subject has a body weight ≥ 50 kg (110 lbs) and a BMI ≥ 23 and ≤ 40 kg/m2 inclusive.
Key exclusion criteria (44 listed)
- Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results. Specific examples are:
- History of previous myocardial infarction or cerebrovascular accident (eg, stroke).
- History or presence of GI, renal, or hepatic disease (with the exception of Gilbert's syndrome), or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- History of cancer, with the exception of non-melanoma skin cancer.
- 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 |
|---|---|---|
| MEDI0382Single dose of MEDI0382 | Drug | MEDI0382 100 mcg Chinese Descent, MEDI0382 100 mcg Japanese Descent, MEDI0382 150 mcg Japanese Descent, MEDI0382 50 mcg Japanese Descent |
| PlaceboSingle dose of placebo | Drug | Placebo Chinese Descent, Placebo Japanese Descent |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Time frame: Day 1 through Day 29
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug and up to Day 29.
Number of Participants With Treatment Emergent Adverse Events of Special Interest (AESIs)
Time frame: Day 1 through Day 29
An AESI (serious or non-serious) was one of scientific and medical interest specific to understanding of study drug and may have required close monitoring and rapid communication by investigator to the sponsor.
Number of Participants With Abnormal Electrocardiogram (ECG) Reported as TEAEs
Time frame: Day 1 through Day 29
Number of participants with TEAEs related to clinically significant ECG abnormalities are reported.
Number of Participants With Vital Signs Abnormalities Reported as TEAEs
Time frame: Day 1 through Day 29
Number of participants with TEAEs related to vital sign abnormalities are reported.
Number of Participants With Abnormal Laboratory parameters Reported as TEAEs
Time frame: Day 1 through Day 29
Number of participants with TEAEs related to clinically significant abnormal laboratory parameter are reported.
7 secondary outcomes
Number of Participants With Postive Anti-Drug Antibodies (ADA) Titer to MEDI0382
Time frame: Baseline (Day-1), Day 8, and Day 29
Maximum Observed Plasma Concentration (Cmax) of MEDI0382
Time frame: Pre dose; and at 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI0382
Time frame: Pre dose; and at 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose
Area Under the Concentration-time Curve From Time Zero to Last Time of Quantifiable Concentration (AUC0 last) of MEDI0382
Time frame: Pre dose; and at 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose
Time to Maximum Observed Plasma Concentration (tmax) of MEDI0382
Time frame: Pre dose; and at 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose
Apparent Terminal Elimination Half-life (t1/2) of MEDI0382
Time frame: Pre dose; and at 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose
Apparent Clearance (CL/F) of MEDI0382
Time frame: Pre dose; and at 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose
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 16 Apr 2019.
- Individual participant dataSharing planned: Undecided
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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.
Peter J Winkle, MD, FACP, FACG, CPI principal investigator
Anaheim Clinical Trials LLC
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 MEDI0382 in people with Safety and Healthy Subjects, 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 11 inclusion and 44 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 16 Apr 2019. 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 Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) (time frame: Day 1 through Day 29). 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 16 Apr 2019.