Heathly SubjectsPhase 1NCT06387966
A Phase I Clinical Study of Flonoltinib Maleate Tablets in Healthy Subjects
A Phase 1 study testing Flonoltinib Maleate Tablets in people with Heathly Subjects, run by Chengdu Zenitar Biomedical Technology Co., Ltd at 1 site in China.
Trial summary
Evaluate the safety , tolerability and pharmacokinetics of Flonoltinib Maleate tablets in a single increasing dose oral administered to healthy adult Chinese subjects.Subjects will divide into experimental group and placebo group, conduct single oral administration safety and tolerability test group by group. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Heathly Subjects
- What is being tested?
- Flonoltinib Maleate Tablets
- 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
- 18 Mar 2024to 15 Aug 2024
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age and gender: 18 to 45 years old (including 18 and 45 years old), no gender limit;
- The weight of male subjects is ≥50.0 kg, the weight of female subjects is ≥45.0 kg, and the body mass index (BMI) is between 19.0 and 25.0 kg/m2 (including the boundary value);
- Those who fully understand the trial content, trial drugs, trial process, etc., can communicate well with the researchers, are willing to comply with the research regulations, voluntarily participate in the trial and sign the informed consent form.
Who cannot join
- Those with a history of severe allergies (such as angioedema and anaphylactic shock), allergies (such as allergies to pollen, two or more drugs/foods), or those with Those who are judged by the researcher to have a clinically significant history of food or drug allergies or other allergic diseases (asthma, urticaria, eczematous dermatitis, etc.); or those who are known to be allergic to JAK inhibitors or to excipients contained in the trial drug ;
- Pre-selection physical examination, vital signs, 12-lead electrocardiogram, laboratory tests (including: blood routine, blood biochemistry, urine routine, blood pregnancy (females only), infectious disease screening, antinuclear antibodies, coagulation function , tuberculosis antibodies, chest anteroposterior X-ray examination, abdominal color ultrasound) results are abnormal and clinically significant;
- QTcF > 440 ms for males and > 460 ms for females on ECG during the screening period;
- Those who have undergone major surgical operations within 3 months before screening or plan to undergo surgery during the trial;
- Those who suffer from acute diseases within 2 weeks before screening; those who have clinically significant infections (such as upper respiratory tract infection, nasopharyngitis, urinary system infection, etc.) within 3 months before screening; those who have any symptoms within 7 days before screening Those with evidence of infection; those with a history of herpes simplex infection or recurrent (>1) herpes zoster or disseminated herpes zoster.
- Have any history of serious clinical diseases or diseases or conditions that the researcher believes may affect the test results, including but not limited to the circulatory system, endocrine system, nervous system, digestive system, urinary system or History of blood, immune, psychiatric and metabolic diseases;
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- Those with a history of dysphagia or any gastrointestinal system disease (or gastrointestinal resection, etc.) that affects drug absorption;
- Those with irregular bowel movements and habitual constipation or diarrhea;
- Those with a history of lipid metabolism defects, such as: familial hyperlipidemia, lipoid nephropathy, or patients with acute pancreatitis accompanied by hyperlipidemia, etc.;
- Those whose urine is positive for multiple combined drug tests (including morphine, methamphetamine, ketamine, methylenedioxyamphetamine, and tetrahydrocannabinolic acid);
- Those who have a history of drug abuse or drug dependence;
- Those who have been vaccinated within 8 weeks before screening, or plan to be vaccinated during the study or within 8 weeks after the administration of study drugs;
- Those who have donated blood or lost ≥400 mL of blood or received blood transfusions within 3 months before screening; or those who have donated blood or blood components within 1 month after the planned trial ends;
- Those who have special requirements for diet or cannot comply with the unified diet and corresponding regulations of the research center;
- Those who smoke more than 3 cigarettes/day or the same amount of tobacco within 3 months before screening; or drink ≥14 units of alcohol per week (1 unit is equal to 17.5mL or 14g of pure alcohol, Approximately equal to 35mL of 50° liquor or 350mL of 5° beer); or those who do not agree to abstain from smoking or drinking during the trial; or those whose alcohol breath test results are positive;
- Those who have taken any prescription drugs, over-the-counter drugs, any vitamin products or Chinese herbal medicines (JAK inhibitors, immunosuppressants, etc.) within 14 days before screening;
- Concomitant use of strong inducers of liver metabolic enzymes (such as: omeprazole, barbiturates, carbamazepine, aminolutamide) within 4 weeks (28 days) before screening (e.g., griseofulvin, methamphetamine, phenytoin, glutamidate, rifampicin, sulfinpyrazone, roxithromycin, etc.), or others judged by the investigator to be likely to affect the pharmacokinetics of the test drug in vivo Medication history learner. Those who have taken any drugs known to cause QT/QTcF interval prolongation or drugs with a risk of causing torsade de pointes (TdP) within 4 weeks (28 days) before screening; or those with long half-life;
- Within 48 hours before administration, consumption of any food or beverage containing caffeine (such as coffee, strong tea, cola, chocolate, etc.), or containing grapefruit juice, etc. may affect metabolism. Foods that may affect enzymes, or those who consume alcoholic foods or drinks;
- Those who participated in other clinical trials and used investigational drugs, vaccines or devices within 3 months before the first dose;
- Pregnant or lactating women or women of childbearing age who have had unprotected sexual intercourse within 14 days before screening;
- During the trial, the subject or his partner is unwilling to use non-drug contraceptive methods (such as complete abstinence, condoms, IUDs, sterilization, etc.) for contraception or after administration of study drugs The subject and/or his or her partner have pregnancy plans within 3 months;
- The subject may not be able to complete the study due to other reasons or the researcher may think there are other factors that make him or her unsuitable to participate in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Dose-escalating, Single-dose, Oral Phase I Clinical Study of the Safety, Tolerability, and Pharmacokinetics of Flonoltinib Maleate Tablets in Healthy Adult Subjects in China
Evaluate the safety , tolerability and pharmacokinetics of Flonoltinib Maleate tablets in a single increasing dose oral administered to healthy adult Chinese subjects.Subjects will divide into experimental group and placebo group, conduct single oral administration safety and tolerability test group by group.
- Conditions
- Heathly Subjects
- Being tested
- Flonoltinib Maleate Tablets, Flonoltinib Maleate Tablets placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flonoltinib Maleate TabletsDrug
Also called 25mg Flonoltinib Maleate Tablets, 50mg Flonoltinib Maleate Tablets, 100mg Flonoltinib Maleate Tablets, 150mg Flonoltinib Maleate Tablets
Day 1 will be used for drug administration, and Day 1~Day 7 will be used for experimental data collection.
Flonoltinib Maleate Tablets placeboDrug
Also called 25mg Flonoltinib Maleate Tablets placebo, 50mg Flonoltinib Maleate Tablets placebo, 100mg Flonoltinib Maleate Tablets placebo, 150mg Flonoltinib Maleate Tablets placebo
Day 1 will be used for drug administration, and Day 1~Day 7 will be used for experimental data collection.
| Study group | Role | What they receive |
|---|---|---|
| Flonoltinib Maleate Tablets treament group | Experimental | Subjects in this group will take Flonoltinib Maleate Tablets Receives: Drug: Flonoltinib Maleate Tablets |
| placebo group | Placebo comparator | Subjects in this group will take Flonoltinib Maleate Tablets placebo Receives: Drug: Flonoltinib Maleate Tablets placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tmax
time to peak
Measured: Day1 Within 30 minutes before administration and 15 minutes, 0.5 hours, 1 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 5hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours after administration
Cmax
maximum concentration
Measured: Day1 Within 30 minutes before administration and 15 minutes, 0.5 hours, 1 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 5hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours after administration
t1/2
Terminal phase elimination half-life
Measured: Day1 Within 30 minutes before administration and 15 minutes, 0.5 hours, 1 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 5hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours after administration
CL/F
Apparent clearance rate
Measured: Day1 Within 30 minutes before administration and 15 minutes, 0.5 hours, 1 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 5hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours after administration
AUC0-t
Area under the blood concentration-time curve from 0 o 'clock to the last measurable concentration at collection time t
Measured: Day1 Within 30 minutes before administration and 15 minutes, 0.5 hours, 1 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 5hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours after administration
AUC0-∞
The area under the blood drug concentration-time curve from 0 to infinity time
Measured: Day1 Within 30 minutes before administration and 15 minutes, 0.5 hours, 1 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 5hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours after administration
Vz/F
apparent volume of distribution
Measured: Day1 Within 30 minutes before administration and 15 minutes, 0.5 hours, 1 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 5hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours after administration
Ae0-144hours and Ae%
The pharmacokinetic statistical parameters of urine are the cumulative excretion (Ae0-144hours) and excretion rate (Ae%) of prototype drugs and major metabolites in urine，that is collected from the 50 mg and 150mg dose groups.
Measured: Day1 Within 2hours before administration and 0~4 hours, 4~8 hours, 8~12 hours, 12~24 hours, 24~36 hours, 36~48 hours, 48~72 hours, 72~96hours, 96~120 hours, 120~144 hours after administration
Ae0-144hours and Ae%
The statistical parameters of fecal pharmacokinetics are the cumulative excretion of prototype drugs and major metabolites in feces (Ae0-144hours) and excretion rate (Ae%) ,that is collected from the 50 mg and 150mg dose groups
Measured: 1 blank fecal sample before administration and after administration: 0~24 hours, 24~48 hours,48~72 hours, 72~96hours, 96~120 hours, 120~144 h ours
Secondary outcomes (1)
security indicators
Observe the changes in vital signs, physical examination, clinical symptoms, laboratory tests, ECG, and occurrence of adverse events of the subjects after medication.
Measured: According to the experimental schedule D-14-D7 or early termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start18 Mar 2024
- Primary completion15 Aug 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heathly SubjectsStudies of the same condition, open and under way.
- More trials run by Chengdu Zenitar Biomedical Technology Co., LtdThe sponsor's other registered studies.
- 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chengdu Zenitar Biomedical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaolan Yong, bachelor, Principal investigator, Chengdu Xinhua Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06387966
- Sponsor's protocol ID
- H-FNTN-PI-Ia
- Status last verified
- Sep 2025
- First submitted
- 6 Mar 2024
- Last updated
- 23 Sep 2025
- 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 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Dose-escalating, Single-dose, Oral Phase I Clinical Study of the Safety, Tolerability, and Pharmacokinetics of Flonoltinib Maleate Tablets in Healthy Adult Subjects in China
- ClinicalTrials.gov ID
- NCT06387966
- Acronym / sponsor ID
- H-FNTN-PI-Ia
- Conditions
- Heathly Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Chengdu Zenitar Biomedical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 29 Apr 2024 (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.
Evaluate the safety , tolerability and pharmacokinetics of Flonoltinib Maleate tablets in a single increasing dose oral administered to healthy adult Chinese subjects.Subjects will divide into experimental group and placebo group, conduct single oral administration safety and tolerability test group by group.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flonoltinib Maleate Tablets treament group | Experimental | Drug: Flonoltinib Maleate TabletsSubjects in this group will take Flonoltinib Maleate Tablets |
| placebo group | Placebo comparator | Drug: Flonoltinib Maleate Tablets placeboSubjects in this group will take Flonoltinib Maleate Tablets placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age and gender: 18 to 45 years old (including 18 and 45 years old), no gender limit;
- The weight of male subjects is ≥50.0 kg, the weight of female subjects is ≥45.0 kg, and the body mass index (BMI) is between 19.0 and 25.0 kg/m2 (including the boundary value);
- Those who fully understand the trial content, trial drugs, trial process, etc., can communicate well with the researchers, are willing to comply with the research regulations, voluntarily participate in the trial and sign the informed consent form.
Key exclusion criteria (22 listed)
- Those with a history of severe allergies (such as angioedema and anaphylactic shock), allergies (such as allergies to pollen, two or more drugs/foods), or those with Those who are judged by the researcher to have a clinically significant history of food or drug allergies or other allergic diseases (asthma, urticaria, eczematous dermatitis, etc.); or those who are known to be allergic to JAK inhibitors or to excipients contained in the trial drug ;
- Pre-selection physical examination, vital signs, 12-lead electrocardiogram, laboratory tests (including: blood routine, blood biochemistry, urine routine, blood pregnancy (females only), infectious disease screening, antinuclear antibodies, coagulation function , tuberculosis antibodies, chest anteroposterior X-ray examination, abdominal color ultrasound) results are abnormal and clinically significant;
- QTcF > 440 ms for males and > 460 ms for females on ECG during the screening period;
- Those who have undergone major surgical operations within 3 months before screening or plan to undergo surgery during the trial;
- Those who suffer from acute diseases within 2 weeks before screening; those who have clinically significant infections (such as upper respiratory tract infection, nasopharyngitis, urinary system infection, etc.) within 3 months before screening; those who have any symptoms within 7 days before screening Those with evidence of infection; those with a history of herpes simplex infection or recurrent (>1) herpes zoster or disseminated herpes zoster.
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 |
|---|---|---|
| Flonoltinib Maleate TabletsAlso: 25mg Flonoltinib Maleate Tablets, 50mg Flonoltinib Maleate Tablets, 100mg Flonoltinib Maleate Tablets, 150mg Flonoltinib Maleate TabletsDay 1 will be used for drug administration, and Day 1~Day 7 will be used for experimental data collection. | Drug | Flonoltinib Maleate Tablets treament group |
| Flonoltinib Maleate Tablets placeboAlso: 25mg Flonoltinib Maleate Tablets placebo, 50mg Flonoltinib Maleate Tablets placebo, 100mg Flonoltinib Maleate Tablets placebo, 150mg Flonoltinib Maleate Tablets placeboDay 1 will be used for drug administration, and Day 1~Day 7 will be used for experimental data collection. | Drug | placebo group |
Primary outcome
Tmax
Time frame: Day1 Within 30 minutes before administration and 15 minutes, 0.5 hours, 1 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 5hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours after administration
time to peak
Cmax
Time frame: Day1 Within 30 minutes before administration and 15 minutes, 0.5 hours, 1 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 5hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours after administration
maximum concentration
t1/2
Time frame: Day1 Within 30 minutes before administration and 15 minutes, 0.5 hours, 1 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 5hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours after administration
Terminal phase elimination half-life
CL/F
Time frame: Day1 Within 30 minutes before administration and 15 minutes, 0.5 hours, 1 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 5hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours after administration
Apparent clearance rate
AUC0-t
Time frame: Day1 Within 30 minutes before administration and 15 minutes, 0.5 hours, 1 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 5hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours after administration
Area under the blood concentration-time curve from 0 o 'clock to the last measurable concentration at collection time t
AUC0-∞
Time frame: Day1 Within 30 minutes before administration and 15 minutes, 0.5 hours, 1 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 5hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours after administration
The area under the blood drug concentration-time curve from 0 to infinity time
Vz/F
Time frame: Day1 Within 30 minutes before administration and 15 minutes, 0.5 hours, 1 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 5hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours after administration
apparent volume of distribution
Ae0-144hours and Ae%
Time frame: Day1 Within 2hours before administration and 0~4 hours, 4~8 hours, 8~12 hours, 12~24 hours, 24~36 hours, 36~48 hours, 48~72 hours, 72~96hours, 96~120 hours, 120~144 hours after administration
The pharmacokinetic statistical parameters of urine are the cumulative excretion (Ae0-144hours) and excretion rate (Ae%) of prototype drugs and major metabolites in urine，that is collected from the 50 mg and 150mg dose groups.
Ae0-144hours and Ae%
Time frame: 1 blank fecal sample before administration and after administration: 0~24 hours, 24~48 hours,48~72 hours, 72~96hours, 96~120 hours, 120~144 h ours
The statistical parameters of fecal pharmacokinetics are the cumulative excretion of prototype drugs and major metabolites in feces (Ae0-144hours) and excretion rate (Ae%) ,that is collected from the 50 mg and 150mg dose groups
1 secondary outcome
security indicators
Time frame: According to the experimental schedule D-14-D7 or early termination
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 23 Sep 2025.
- 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.
Xiaolan Yong, bachelor principal investigator
Chengdu Xinhua Hospital
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 Flonoltinib Maleate Tablets in people with Heathly Subjects, run by Chengdu Zenitar Biomedical Technology 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 3 inclusion and 22 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 23 Sep 2025. 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?
Tmax (time frame: Day1 Within 30 minutes before administration and 15 minutes, 0.5 hours, 1 hours, 2 hours, 2.5 hours, 3 hours, 3.5 hours, 4 hours, 5hours, 6 hours, 8 hours, 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours after administration). The study lists 9 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 23 Sep 2025.