Parkinson DiseasePhase 1NCT04693039
Study on the Safety, Tolerance and Pharmacokinetics of Phenlarmide Tablets
A Phase 1 study testing Phenlarmide in people with Parkinson Disease, run by Shijiazhuang Yiling Pharmaceutical Co. Ltd at 1 site in China.
Trial summary
1. To evaluate the safety and tolerability of Phenlarmide tablets in patients with Parkinson's disease in the early and middle stages. 2. To evaluate the pharmacokinetics of Phenlarmide tablets in patients with Parkinson's disease. 3. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Phenlarmide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 23 Feb 2021to 29 Oct 2021
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understand and sign the informed consent, understand the research process and requirements, and volunteer to participate in the study;
- over 30 years old and have no gender limit;
- Patients diagnosed with Parkinson's disease according to the Chinese diagnostic criteria for Parkinson's disease (2016 Edition);
- Hoehn-Yahr grade ≤ 3;
- The Unified Parkinson's disease scale (UPDRS) motor score (Part III) ≥ 10;
- Not using anti Parkinson's disease drugs within 28 days before enrollment;
- If the subjects are receiving dopamine receptor agonists (such as Pramipexole, etc.), anticholinergic drugs (such as Benzhexol Hydrochloride, etc.), monoamine oxidase B (MAO-B) inhibitors (such as Selegiline, Rasagiline, etc.), and N-methyl-D-aspartate (NMDA) receptor antagonists (such as Amantadine), they should stop using the drugs 28 days before the screening period;
- Patients who had been treated with levodopa preparation (including levodopa compound preparation) for less than 6 months before screening, and had not received levodopa preparation treatment within 28 days before screening period.
Who cannot join
- Atypical Parkinson's symptoms due to the use of drugs (such as Flunarizine, Metoclopramide), nervous system diseases, genetic metabolic diseases, encephalitis, cerebrovascular diseases or other degenerative diseases (such as progressive supranuclear paralysis);
- Patients with dementia, active mental illness or hallucination, severe depression (Beck Depression Scale - Ⅱ ≥ 29 points at screening), or Mini-Mental State Examination (MMSE) < 25 points;
- Those who have received neurosurgical operation or electrical stimulation (such as pallidotomy, thalamotomy, deep brain electrical stimulation, etc.);
- Patients with clinically significant abnormal liver function were defined as total bilirubin > 1.5 times of the upper limit of normal value or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 times of the upper limit of normal value;
- Patients with clinically significant renal dysfunction: creatinine clearance rate (CCR) < 30 ml / min (using Cockcroft-Gault formula);
- Patients with uncontrollable or severe cardiovascular diseases, including NYHA grade II or above congestive heart failure, unstable angina pectoris, myocardial infarction, arrhythmia requiring treatment at the time of screening, and QTc interval prolongation more than 480ms, in 6 months before the first administration of trial drug;
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- There is a history of heart, liver, kidney, respiratory, digestive, endocrine, immune or blood system diseases considered by researchers to be serious;
- During the screening period, the patients with HIV positive, HBV or HCV infection and syphilis infection were active;
- Patients with malignant tumor within 5 years before screening were excluded from cervical carcinoma in situ, skin basal cell or squamous cell carcinoma, local prostate cancer after radical operation and breast intraductal carcinoma in situ after radical operation;
- There were significant food or drug allergy history or hypersensitivity reaction judged by researchers as having clinical significance;
- Participants in any clinical trials within 3 months before administration of the study;
- Pregnant or lactating women, or those whose serum hCG test is positive before trial administration, who are unable or unwilling to take contraceptive measures approved by the researcher during the study period and within 3 months after the end of the study according to the instructions of the researcher;
- Those considered unsuitable by the researchers to participate in this clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerance and Pharmacokinetics of Phenlarmide Tablets in Patients With Parkinson's Disease in the Early and Middle Stages
- To evaluate the safety and tolerability of Phenlarmide tablets in patients with Parkinson's disease in the early and middle stages.
- To evaluate the pharmacokinetics of Phenlarmide tablets in patients with Parkinson's disease.
- To explore the efficacy of Phenlarmide tablets in the treatment of early and mid-term Parkinson's disease.
Read the detailed description
- Objective to evaluate the tolerance and safety of multiple administration of fenloramide tablets in patients with early and mid-term Parkinson's disease: To evaluate the adverse events of DLT and MTD, adverse reactions, clinical laboratory tests (blood routine, blood biochemistry, coagulation function, urine routine, stool routine), vital signs, 12 lead ECG and physical examination of fenloramide tablets in patients with early and mid-term Parkinson's disease .
- Objective to evaluate the pharmacokinetics of fenloramide tablets in patients with Parkinson's disease in early and middle stages. The main PK parameters included Tmax, SS, Cmax, SS, cavg, SS, Ke, T1 / 2, Cl / F (only fenloramide prototype), VZ / F (only fenloramide prototype), auc0-24, SS, aucinf, SS, auc0 last, SS, AUC_ %Extrap, DF, etc.
- Objective to explore the efficacy of fenloramide tablets in the treatment of early and mid-term Parkinson's disease, and to observe the changes of UPDRS and CGI.
- Conditions
- Parkinson Disease
- Being tested
- Phenlarmide, Placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenlarmideDrug
Also called FLZ-150mg, FLZ-300mg, FLZ-600mg, FLZ-900mg
Dosage form：Tablet; Give the medicine once a day，4 weeks is a cycle of administration, a total of 3 cycles of administration.
PlaceboDrug
Also called Placebo-150mg, Placebo-300mg, Placebo-600mg, Placebo-900mg
Dosage form：Tablet; Give the medicine once a day，4 weeks is a cycle of administration, a total of 3 cycles of administration.
| Study group | Role | What they receive |
|---|---|---|
| FLZ-150mg | Experimental | Drug：Phenlarmide；Dosage：150mg； Receives: Drug: Phenlarmide |
| FLZ-300mg | Experimental | Drug：Phenlarmide；Dosage：300mg； Receives: Drug: Phenlarmide |
| FLZ-600mg | Experimental | Drug：Phenlarmide；Dosage：600mg； Receives: Drug: Phenlarmide |
| FLZ-900mg | Experimental | Drug：Phenlarmide；Dosage：900mg； Receives: Drug: Phenlarmide |
| Placebo-150mg | Placebo comparator | Drug：Placebo；Dosage：150mg； Receives: Drug: Placebo |
| Placebo-300mg | Placebo comparator | Drug：Placebo；Dosage：300mg； Receives: Drug: Placebo |
| Placebo-600mg | Placebo comparator | Drug：Placebo；Dosage：600mg； Receives: Drug: Placebo |
| Placebo-900mg | Placebo comparator | Drug：Placebo；Dosage：900mg； Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the dose limiting toxicity (DLT)
The occurrence of Dose limiting toxicity.
Measured: through study completion, an average of 6 months
Tmax, ss
After administration, the time when the highest concentration of drug appeared in plasma
Measured: through study completion, an average of 6 months
Efficacy evaluation
explore the efficacy of fenolamide tablets in the treatment of early and middle stage Parkinson's disease, and observe the changes of UPDRS and CGI.
Measured: through study completion, an average of 6 months
maximum tolerable dose (MTD)
The occurrence of Maximum tolerable dose.
Measured: through study completion, an average of 6 months
adverse events
The occurrence rate of adverse events.
Measured: through study completion, an average of 6 months
adverse reactions
The occurrence rate of adverse reactions
Measured: through study completion, an average of 6 months
blood routine
Check whether the red blood cell system, white blood cell system and platelet system are normal
Measured: through study completion, an average of 6 months
blood biochemistry
The contents of various ions, sugars, lipids, proteins, enzymes, hormones and metabolites in blood were detected
Measured: through study completion, an average of 6 months
coagulation function
Four coagulation parameters including prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT) and fibrinogen (FIB) were evaluated.
Measured: through study completion, an average of 6 months
urine routine
Urine routine examination includes urine color, transparency, pH, red blood cells, white blood cells, epithelial cells, tube type, protein, specific gravity and urine sugar.
Measured: through study completion, an average of 6 months
stool routine
Routine stool tests include the detection of red and white blood cells in feces, bacterial sensitivity test, occult blood test (OB) and inspection of eggs.
Measured: through study completion, an average of 6 months
Body temperature
One of the vital signs.
Measured: through study completion, an average of 6 months
12 lead ECG
Evaluation of QT interval
Measured: through study completion, an average of 6 months
Blood pressure
Assess whether systolic blood pressure and diastolic blood pressure are normal.
Measured: through study completion, an average of 6 months
Heart rate
One of the vital signs.
Measured: through study completion, an average of 6 months
Breathing
Assess if breathing is normal
Measured: through study completion, an average of 6 months
Cmax, ss
The highest concentration of the drug in the plasma after administration
Measured: through study completion, an average of 6 months
Cavg, ss
The quotient of the area under the plasma concentration time curve divided by the interval time within a dose interval after the plasma concentration reaches the steady state.
Measured: through study completion, an average of 6 months
Ke
The ratio of the amount of compound eliminated from the body to the total amount in the body in unit time
Measured: through study completion, an average of 6 months
t1/2
The time required for the concentration of a drug to drop by half in an organism
Measured: through study completion, an average of 6 months
CL/F (fenoxamide prototype only)
The amount of a substance excreted by the kidney per minute
Measured: through study completion, an average of 6 months
Vz/F (fenoxamide prototype only)
After the drug reaches dynamic equilibrium in the body, the ratio of the drug dose in the body to the blood concentration is called the apparent distribution volume
Measured: through study completion, an average of 6 months
AUC0-24, ss
After administration, the area under the 0-24 hour time curve of blood concentration absorbed into human circulation
Measured: through study completion, an average of 6 months
AUCinf, ss
After administration, the area under the time curve of 0-infinity of the blood concentration absorbed into human circulation
Measured: through study completion, an average of 6 months
AUC0-last，ss
After administration, the area under the time curve of 0-the last accurately determined sample collection time of the blood concentration absorbed into human circulation
Measured: through study completion, an average of 6 months
AUC_%Extrap
the area under the curve that has been derived after extrapolation of Residual Area
Measured: through study completion, an average of 6 months
DF
The index reflecting the unbalanced situation of transportation in time
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start23 Feb 2021
- Primary completion29 Oct 2021
- Study completion29 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shijiazhuang Yiling Pharmaceutical Co. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Xuanwu Hospital, Beijing
- Responsible party
- Sponsor
- Investigators
- biao chen, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04693039
- Sponsor's protocol ID
- FLZPD1003
- Status last verified
- Dec 2021
- First submitted
- 28 Dec 2020
- Last updated
- 3 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerance and Pharmacokinetics of Phenlarmide Tablets in Patients With Parkinson's Disease in the Early and Middle Stages
- ClinicalTrials.gov ID
- NCT04693039
- Acronym / sponsor ID
- FLZPD1003
- Conditions
- Parkinson Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Shijiazhuang Yiling Pharmaceutical Co. LtdIndustry (pharma, biotech, devices)
- Collaborators
- Xuanwu Hospital, Beijing
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 29 Oct 2021 (actual)
- Study completion
- 29 Oct 2021 (actual)
- First posted
- 5 Jan 2021 (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.
- To evaluate the safety and tolerability of Phenlarmide tablets in patients with Parkinson's disease in the early and middle stages.
- To evaluate the pharmacokinetics of Phenlarmide tablets in patients with Parkinson's disease.
- To explore the efficacy of Phenlarmide tablets in the treatment of early and mid-term Parkinson's disease.
Detailed description
- Objective to evaluate the tolerance and safety of multiple administration of fenloramide tablets in patients with early and mid-term Parkinson's disease: To evaluate the adverse events of DLT and MTD, adverse reactions, clinical laboratory tests (blood routine, blood biochemistry, coagulation function, urine routine, stool routine), vital signs, 12 lead ECG and physical examination of fenloramide tablets in patients with early and mid-term Parkinson's disease .
- Objective to evaluate the pharmacokinetics of fenloramide tablets in patients with Parkinson's disease in early and middle stages. The main PK parameters included Tmax, SS, Cmax, SS, cavg, SS, Ke, T1 / 2, Cl / F (only fenloramide prototype), VZ / F (only fenloramide prototype), auc0-24, SS, aucinf, SS, auc0 last, SS, AUC_ %Extrap, DF, etc.
- Objective to explore the efficacy of fenloramide tablets in the treatment of early and mid-term Parkinson's disease, and to observe the changes of UPDRS and CGI.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| FLZ-150mg | Experimental | Drug: PhenlarmideDrug：Phenlarmide；Dosage：150mg； |
| FLZ-300mg | Experimental | Drug: PhenlarmideDrug：Phenlarmide；Dosage：300mg； |
| FLZ-600mg | Experimental | Drug: PhenlarmideDrug：Phenlarmide；Dosage：600mg； |
| FLZ-900mg | Experimental | Drug: PhenlarmideDrug：Phenlarmide；Dosage：900mg； |
| Placebo-150mg | Placebo comparator | Drug: PlaceboDrug：Placebo；Dosage：150mg； |
| Placebo-300mg | Placebo comparator | Drug: PlaceboDrug：Placebo；Dosage：300mg； |
| Placebo-600mg | Placebo comparator | Drug: PlaceboDrug：Placebo；Dosage：600mg； |
| Placebo-900mg | Placebo comparator | Drug: PlaceboDrug：Placebo；Dosage：900mg； |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Understand and sign the informed consent, understand the research process and requirements, and volunteer to participate in the study;
- over 30 years old and have no gender limit;
- Patients diagnosed with Parkinson's disease according to the Chinese diagnostic criteria for Parkinson's disease (2016 Edition);
- Hoehn-Yahr grade ≤ 3;
- The Unified Parkinson's disease scale (UPDRS) motor score (Part III) ≥ 10;
Key exclusion criteria (13 listed)
- Atypical Parkinson's symptoms due to the use of drugs (such as Flunarizine, Metoclopramide), nervous system diseases, genetic metabolic diseases, encephalitis, cerebrovascular diseases or other degenerative diseases (such as progressive supranuclear paralysis);
- Patients with dementia, active mental illness or hallucination, severe depression (Beck Depression Scale - Ⅱ ≥ 29 points at screening), or Mini-Mental State Examination (MMSE) < 25 points;
- Those who have received neurosurgical operation or electrical stimulation (such as pallidotomy, thalamotomy, deep brain electrical stimulation, etc.);
- Patients with clinically significant abnormal liver function were defined as total bilirubin > 1.5 times of the upper limit of normal value or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 times of the upper limit of normal value;
- Patients with clinically significant renal dysfunction: creatinine clearance rate (CCR) < 30 ml / min (using Cockcroft-Gault formula);
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 |
|---|---|---|
| PhenlarmideAlso: FLZ-150mg, FLZ-300mg, FLZ-600mg, FLZ-900mgDosage form：Tablet; Give the medicine once a day，4 weeks is a cycle of administration, a total of 3 cycles of administration. | Drug | FLZ-150mg, FLZ-300mg, FLZ-600mg, FLZ-900mg |
| PlaceboAlso: Placebo-150mg, Placebo-300mg, Placebo-600mg, Placebo-900mgDosage form：Tablet; Give the medicine once a day，4 weeks is a cycle of administration, a total of 3 cycles of administration. | Drug | Placebo-150mg, Placebo-300mg, Placebo-600mg, Placebo-900mg |
Primary outcome
the dose limiting toxicity (DLT)
Time frame: through study completion, an average of 6 months
The occurrence of Dose limiting toxicity.
Tmax, ss
Time frame: through study completion, an average of 6 months
After administration, the time when the highest concentration of drug appeared in plasma
Efficacy evaluation
Time frame: through study completion, an average of 6 months
explore the efficacy of fenolamide tablets in the treatment of early and middle stage Parkinson's disease, and observe the changes of UPDRS and CGI.
maximum tolerable dose (MTD)
Time frame: through study completion, an average of 6 months
The occurrence of Maximum tolerable dose.
adverse events
Time frame: through study completion, an average of 6 months
The occurrence rate of adverse events.
adverse reactions
Time frame: through study completion, an average of 6 months
The occurrence rate of adverse reactions
blood routine
Time frame: through study completion, an average of 6 months
Check whether the red blood cell system, white blood cell system and platelet system are normal
blood biochemistry
Time frame: through study completion, an average of 6 months
The contents of various ions, sugars, lipids, proteins, enzymes, hormones and metabolites in blood were detected
coagulation function
Time frame: through study completion, an average of 6 months
Four coagulation parameters including prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT) and fibrinogen (FIB) were evaluated.
urine routine
Time frame: through study completion, an average of 6 months
Urine routine examination includes urine color, transparency, pH, red blood cells, white blood cells, epithelial cells, tube type, protein, specific gravity and urine sugar.
stool routine
Time frame: through study completion, an average of 6 months
Routine stool tests include the detection of red and white blood cells in feces, bacterial sensitivity test, occult blood test (OB) and inspection of eggs.
Body temperature
Time frame: through study completion, an average of 6 months
One of the vital signs.
12 lead ECG
Time frame: through study completion, an average of 6 months
Evaluation of QT interval
Blood pressure
Time frame: through study completion, an average of 6 months
Assess whether systolic blood pressure and diastolic blood pressure are normal.
Heart rate
Time frame: through study completion, an average of 6 months
One of the vital signs.
Breathing
Time frame: through study completion, an average of 6 months
Assess if breathing is normal
Cmax, ss
Time frame: through study completion, an average of 6 months
The highest concentration of the drug in the plasma after administration
Cavg, ss
Time frame: through study completion, an average of 6 months
The quotient of the area under the plasma concentration time curve divided by the interval time within a dose interval after the plasma concentration reaches the steady state.
Ke
Time frame: through study completion, an average of 6 months
The ratio of the amount of compound eliminated from the body to the total amount in the body in unit time
t1/2
Time frame: through study completion, an average of 6 months
The time required for the concentration of a drug to drop by half in an organism
CL/F (fenoxamide prototype only)
Time frame: through study completion, an average of 6 months
The amount of a substance excreted by the kidney per minute
Vz/F (fenoxamide prototype only)
Time frame: through study completion, an average of 6 months
After the drug reaches dynamic equilibrium in the body, the ratio of the drug dose in the body to the blood concentration is called the apparent distribution volume
AUC0-24, ss
Time frame: through study completion, an average of 6 months
After administration, the area under the 0-24 hour time curve of blood concentration absorbed into human circulation
AUCinf, ss
Time frame: through study completion, an average of 6 months
After administration, the area under the time curve of 0-infinity of the blood concentration absorbed into human circulation
AUC0-last，ss
Time frame: through study completion, an average of 6 months
After administration, the area under the time curve of 0-the last accurately determined sample collection time of the blood concentration absorbed into human circulation
AUC_%Extrap
Time frame: through study completion, an average of 6 months
the area under the curve that has been derived after extrapolation of Residual Area
DF
Time frame: through study completion, an average of 6 months
The index reflecting the unbalanced situation of transportation in time
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 3 Jan 2022.
- Individual participant dataSharing planned: No
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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.
biao chen principal investigator
Xuanwu Hospital, Beijing
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 Phenlarmide in people with Parkinson Disease, run by Shijiazhuang Yiling Pharmaceutical Co. Ltd at 1 site in China.
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 8 inclusion and 13 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 3 Jan 2022. 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 China. 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?
the dose limiting toxicity (DLT) (time frame: through study completion, an average of 6 months). The study lists 27 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 3 Jan 2022.