PNH - Paroxysmal Nocturnal HemoglobinuriaPhase 1NCT07256301
A Phase Ib, Multicenter, Open-Label Study of Multiple-Dose EA5 in Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH)
A Phase 1 study testing EA5 in people with PNH - Paroxysmal Nocturnal Hemoglobinuria, run by Shanghai Lanyi Therapeutics Co., Ltd. at 2 sites in China.
Trial summary
This is a multicenter, open-label, Phase Ib clinical trial designed to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of the humanized monoclonal antibody EA5 in adult patients with paroxysmal nocturnal hemoglobinuria (PNH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PNH - Paroxysmal Nocturnal Hemoglobinuria
- What is being tested?
- EA5
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesChina
- Study dates
- 3 Jan 2024to 30 Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged ≥18 years.
- Body weight between 40 kg and 100 kg (inclusive) at screening.
- Patients diagnosed with PNH, confirmed by flow cytometry demonstrating a PNH clone size (glycosylphosphatidylinositol-anchored protein-deficient granulocytes or monocytes) of ≥10% in peripheral blood, and meeting one of the following criteria:
- a) Previously naive to complement inhibitor therapy; or
- b) Previously treated with a complement inhibitor, which has been discontinued for ≥5 half-lives prior to screening.
- Lactate dehydrogenase (LDH) level ≥1.5 times the upper limit of normal (ULN) at screening.
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- Presence of one or more of the following PNH-related signs or symptoms within 3 months prior to screening: fatigue, hemoglobinuria, abdominal pain, shortness of breath (dyspnea), anemia (hemoglobin <10 g/dL), history of major thrombotic event (including thrombosis), dysphagia, or erectile dysfunction; or a history of packed red blood cell (pRBC) transfusion due to PNH.
- Vaccination against Neisseria meningitidis(serogroups A, C, W, Y) within <3 years prior to the initiation of study treatment; OR if not previously vaccinated, receipt of the meningococcal vaccine (MPV-ACYW) at least 14 days prior to the first dose of the investigational product. If the vaccine is administered within 14 days before dosing, antibiotic prophylaxis must be provided until 2 weeks post-vaccination.
- Vaccination against Streptococcus pneumoniaeaccording to national vaccination recommendations (e.g., ACIP guidelines). OR if not previously vaccinated, receipt of the pneumococcal vaccine at least 14 days prior to the first dose of the investigational product. If the vaccine is administered within 14 days before dosing, antibiotic prophylaxis must be provided until 2 weeks post-vaccination.
- For patients receiving concomitant therapies (e.g., immunosuppressants, corticosteroids, iron supplements, anticoagulants, erythropoiesis-stimulating agents): the dose must have been stable for ≥28 days prior to the first dose of the investigational product.
- Platelet count ≥30 × 10^9/L at screening (without transfusion support within 7 days), and absolute neutrophil count (ANC) ≥0.5 × 10^9/L (without short-acting granulocyte colony-stimulating factor (G-CSF) within 14 days or long-acting G-CSF within 28 days).
- Adequate liver function, defined as alanine aminotransferase (ALT) ≤3 × ULN, OR both direct bilirubin and alkaline phosphatase (ALP) ≤2 × ULN at screening.
- Adequate renal function, defined as serum creatinine ≤2.5 × ULN and an estimated creatinine clearance ≥30 mL/min as calculated by the Cockcroft-Gault formula.
- Male subjects must agree to use effective contraception (including vasectomy, abstinence, or condom) from screening until 6 months after the final study intervention. Women of childbearing potential (WOCBP) must have a negative blood pregnancy test at screening and baseline. During the study and for 6 months thereafter, all subjects and their partners must agree to use effective contraceptive measures (Note: contraceptive measures include both pharmacological and non-pharmacological methods).
- Ability to understand the procedures and methods of the study, willingness to provide written informed consent, and commitment to strictly adhere to the clinical study protocol to complete the study.
Who cannot join
- History of allogeneic bone marrow transplantation.
- History of Neisseria meningitidisinfection within 6 months prior to screening and before the first dose.
- Known or suspected immunodeficiency (e.g., history of frequent or recurrent infections).
- Known or suspected hereditary complement deficiency.
- Evidence of active tuberculosis (TB) within 6 months prior to screening, or a history of active TB without having completed an appropriate, documented course of treatment; OR chest X-ray (posteroanterior and lateral) or CT scan findings during the 3 months prior to screening or during the screening period that suggest the presence of active TB infection.
- History of major surgery (Grade 3 or 4 surgery) within 3 months prior to the first dose.
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- Presence of an autoimmune disease, OR use of systemic immunosuppressive/immunomodulatory agents (including, but not limited to, methotrexate, cyclosporine, mycophenolate, tacrolimus, penicillamine, sulfasalazine, hydroxychloroquine, azathioprine, cyclophosphamide) for the treatment of inflammatory diseases within 12 weeks or 5 half-lives (whichever is longer) prior to screening.
- Active systemic bacterial, viral, or fungal infection within 14 days prior to the first dose; OR requirement for hospitalization or intravenous antibiotic therapy for an infection between 28 days prior to screening and the first dose; OR requirement for oral antibiotic therapy for an infection between 14 days prior to screening and the first dose.
- Occurrence of fever (≥38°C) within 7 days prior to the first drug administration.
- Administration of any live-attenuated vaccine within 1 month prior to the first dose.
- History of malignancy within 5 years prior to screening and before the first dose, with the following exceptions: patients with any malignancy that has been treated with curative intent and who have been disease-free and off treatment for >5 years prior to the first dose may be enrolled. Patients with a history of basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situof the cervix that has been cured with no evidence of recurrence at any time prior to the first dose may be enrolled. Patients with a history of low-grade, early-stage prostate cancer (Gleason score ≤6, Stage 1 or 2) not requiring treatment at any time prior to the first dose may be enrolled.
- History of allergy to any component of EA5, including a history of hypersensitivity to human, humanized, or murine monoclonal antibodies, or known hypersensitivity to any excipient of the product.
- Any contraindication to receiving the meningococcal vaccination and/or antibiotic prophylaxis (e.g., beta-lactam antibiotics, ciprofloxacin) as required by the study protocol.
- Participation in another interventional therapeutic clinical trial involving an investigational drug or receipt of any experimental therapy within 3 months (or within 5 half-lives of the investigational agent, whichever is longer) prior to screening.
- History of drug abuse within 12 months prior to screening, as judged by the investigator.
- Alcohol abuse, or regular alcohol consumption exceeding 14 units per week within 6 months prior to screening (1 unit of alcohol ≈ 360 mL of beer, or 45 mL of 40% spirits, or 150 mL of wine).
- Splenectomy performed within ≤6 months prior to screening.
- Positive for hepatitis C virus (HCV) antibody at screening (except for those with a negative HCV RNA result), positive for human immunodeficiency virus (HIV) antibody, positive for anti-Treponema pallidumantibody (TP-Ab) (except for those with a negative RPR or TRUST test), OR positive for hepatitis B virus (HBV) surface antigen (HBsAg) (except for those with an HBV DNA level ≤1000 IU/mL).
- History of or ongoing cryoglobulinemia at the time of screening.
- History of myelodysplastic syndromes (MDS), with a Revised International Prognostic Scoring System (IPSS-R) risk category of Intermediate, High, or Very High.
- Any other condition that, in the opinion of the investigator, renders the subject unsuitable for participation in the trial.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine, Chengzhan Campus
Hangzhou, Zhejiang, 310009
Hongyan Tong, Dr., +86-0571-56181000, hongyantong@yahoo.com.cn
Hongyan Tong, Dr.
- Recruiting
The Institute of Hematology & Blood Diseases Hospital (Chinese Academy of Medical Sciences)
Tianjin, Tianjin Municipality, 300020
Fengkui Zhang, Dr., +86-022-23909999, zhfk@hotmail.com
Fengkui Zhang, Dr.
About this study
Official title: A Multicenter, Open-Label, Phase Ib Clinical Trial to Evaluate the Safety, Pharmacokinetic, and Pharmacodynamic Profiles of Multiple Doses of the Humanized Monoclonal Antibody EA5 in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)
This is a multicenter, open-label, Phase Ib clinical trial designed to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of the humanized monoclonal antibody EA5 in adult patients with paroxysmal nocturnal hemoglobinuria (PNH).
Read the detailed description
This is a multicenter, open-label, Phase Ib clinical trial designed to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of the humanized monoclonal antibody EA5 in adult patients with paroxysmal nocturnal hemoglobinuria (PNH). The study plans to enroll 24-26 PNH patients. The primary objective is to assess the incidence and severity of adverse events (AEs) from baseline to Week 14.The treatment period is divided into a Loading Phase (Day 1 to Day 14) and a Maintenance Phase (Day 15 to Day 85). During the maintenance phase, patients will be assigned to one of three dose cohorts: Cohort 1/Cohort 1' (900 mg, IV, Q4W), Cohort 2/Cohort 2' (1200 mg, IV, Q4W), and Cohort 3 (1400 mg, IV, Q4W). Cohorts 1-3 are for patients previously naive to complement inhibitor therapy, while Cohorts 1'-2' are for patients recently naive to complement inhibitor therapy.
- Being tested
- EA5
- Keywords
- EA5、PNH、Paroxysmal Nocturnal Hemoglobinuria、C5 complement inhibitor
- Medical subject headings
- Hemoglobinuria, Paroxysmal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EA5Biological
All treatments were given as IV infusions.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 and Cohort 1' | Experimental | Participants were administered EA5 900 milligram (mg) on Day 1 and Day 8, EA5 900 mg on Day 15, and then EA5 900 mg every 4 weeks for 2 doses. Receives: Biological: EA5 |
| Cohort 2 and Cohort 2' | Experimental | Participants were administered EA5 900 milligram (mg) on Day 1 and Day 8, EA5 1200 mg on Day 15, and then EA5 1200 mg every 4 weeks for 2 doses. Receives: Biological: EA5 |
| Cohort 3 | Experimental | Participants were administered EA5 900 milligram (mg) on Day 1 and Day 8, EA5 1400 mg on Day 15, and then EA5 1400 mg every 4 weeks for 2 doses. Receives: Biological: EA5 |
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)
TEAEs were defined as AEs that occurred on or after the date and time of study drug administration, or those that first occurred before dosing but worsened in frequency or severity after study drug administration. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Measured: Baseline up to Week 14
Secondary outcomes (11)
Maximum Observed Serum Concentration (Cmax) of EA5
Blood samples were collected for analysis of Cmax
Measured: Baseline up to Week 14
Time To Maximum Observed Serum Concentration (Tmax) of EA5
Blood samples were collected for analysis of Tmax
Measured: Baseline up to Week 14
Area Under The Serum Concentration Versus Time Curve From Time Zero To The Time of The Last Quantifiable Concentration (AUC0-t) of EA5
Blood samples were collected for analysis of AUC0-t
Measured: Baseline up to Week 14
Area Under The Serum Concentration Versus Time Curve From Time Zero (Dosing) To Infinity (AUCinf) of EA5
Blood samples were collected for analysis of AUCinf
Measured: Baseline up to Week 14
Terminal Elimination Rate Constant (λz) of Serum EA5
Blood samples were collected for analysis of λz
Measured: Baseline up to Week 14
Terminal Elimination Half-life (t½) of Serum EA5
Blood samples were collected for analysis of t½
Measured: Baseline up to Week 14
Total Clearance (CL) of EA5
Blood samples were collected for analysis of CL
Measured: Baseline up to Week 14
Percent Change From Baseline in Free Complement Component 5 (C5)
Blood samples were collected for analysis of free C5 concentrations.
Measured: Baseline up to Week 14
Percent Change From Baseline in Total Complement C5
Blood samples were collected for analysis of total C5 concentrations.
Measured: Baseline up to Week 14
Percent Change From Baseline in determination of terminal complement activity in serum
Blood samples were collected for analysis of determination of terminal complement activity
Measured: Baseline up to Week 14
Percentage of Participants With Positive Anti-Drug Antibody (ADA)
Blood samples were collected to evaluate antibody response through development of ADAs.
Measured: Baseline up to Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start3 Jan 2024
- Primary completion31 Aug 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PNH - Paroxysmal Nocturnal HemoglobinuriaStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Lanyi Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fengkui Zhang, Dr., Principal investigator, The Institute of Hematology & Blood Diseases Hospital (Chinese Academy of Medical Sciences)Hongyan Tong, Dr., Principal investigator, The First Affiliated Hospital, Zhejiang University School of Medicine, Chengzhan Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07256301
- Sponsor's protocol ID
- C-EA5-2401
- Status last verified
- May 2026
- First submitted
- 20 Nov 2025
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Phase Ib Clinical Trial to Evaluate the Safety, Pharmacokinetic, and Pharmacodynamic Profiles of Multiple Doses of the Humanized Monoclonal Antibody EA5 in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)
- ClinicalTrials.gov ID
- NCT07256301
- Acronym / sponsor ID
- C-EA5-2401
- Keywords
- EA5、PNH、Paroxysmal Nocturnal Hemoglobinuria、C5 complement inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Shanghai Lanyi Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 1 Dec 2025 (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 multicenter, open-label, Phase Ib clinical trial designed to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of the humanized monoclonal antibody EA5 in adult patients with paroxysmal nocturnal hemoglobinuria (PNH).
Detailed description
This is a multicenter, open-label, Phase Ib clinical trial designed to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of the humanized monoclonal antibody EA5 in adult patients with paroxysmal nocturnal hemoglobinuria (PNH). The study plans to enroll 24-26 PNH patients. The primary objective is to assess the incidence and severity of adverse events (AEs) from baseline to Week 14.The treatment period is divided into a Loading Phase (Day 1 to Day 14) and a Maintenance Phase (Day 15 to Day 85). During the maintenance phase, patients will be assigned to one of three dose cohorts: Cohort 1/Cohort 1' (900 mg, IV, Q4W), Cohort 2/Cohort 2' (1200 mg, IV, Q4W), and Cohort 3 (1400 mg, IV, Q4W). Cohorts 1-3 are for patients previously naive to complement inhibitor therapy, while Cohorts 1'-2' are for patients recently naive to complement inhibitor therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 and Cohort 1' | Experimental | Biological: EA5Participants were administered EA5 900 milligram (mg) on Day 1 and Day 8, EA5 900 mg on Day 15, and then EA5 900 mg every 4 weeks for 2 doses. |
| Cohort 2 and Cohort 2' | Experimental | Biological: EA5Participants were administered EA5 900 milligram (mg) on Day 1 and Day 8, EA5 1200 mg on Day 15, and then EA5 1200 mg every 4 weeks for 2 doses. |
| Cohort 3 | Experimental | Biological: EA5Participants were administered EA5 900 milligram (mg) on Day 1 and Day 8, EA5 1400 mg on Day 15, and then EA5 1400 mg every 4 weeks for 2 doses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Male or female subjects aged ≥18 years.
- Body weight between 40 kg and 100 kg (inclusive) at screening.
- Patients diagnosed with PNH, confirmed by flow cytometry demonstrating a PNH clone size (glycosylphosphatidylinositol-anchored protein-deficient granulocytes or monocytes) of ≥10% in peripheral blood, and meeting one of the following criteria:
- Lactate dehydrogenase (LDH) level ≥1.5 times the upper limit of normal (ULN) at screening.
- Presence of one or more of the following PNH-related signs or symptoms within 3 months prior to screening: fatigue, hemoglobinuria, abdominal pain, shortness of breath (dyspnea), anemia (hemoglobin <10 g/dL), history of major thrombotic event (including thrombosis), dysphagia, or erectile dysfunction; or a history of packed red blood cell (pRBC) transfusion due to PNH.
Key exclusion criteria (21 listed)
- History of allogeneic bone marrow transplantation.
- History of Neisseria meningitidisinfection within 6 months prior to screening and before the first dose.
- Known or suspected immunodeficiency (e.g., history of frequent or recurrent infections).
- Known or suspected hereditary complement deficiency.
- Evidence of active tuberculosis (TB) within 6 months prior to screening, or a history of active TB without having completed an appropriate, documented course of treatment; OR chest X-ray (posteroanterior and lateral) or CT scan findings during the 3 months prior to screening or during the screening period that suggest the presence of active TB infection.
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 |
|---|---|---|
| EA5All treatments were given as IV infusions. | Biological | Cohort 1 and Cohort 1', Cohort 2 and Cohort 2', Cohort 3 |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Baseline up to Week 14
TEAEs were defined as AEs that occurred on or after the date and time of study drug administration, or those that first occurred before dosing but worsened in frequency or severity after study drug administration. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
11 secondary outcomes
Maximum Observed Serum Concentration (Cmax) of EA5
Time frame: Baseline up to Week 14
Time To Maximum Observed Serum Concentration (Tmax) of EA5
Time frame: Baseline up to Week 14
Area Under The Serum Concentration Versus Time Curve From Time Zero To The Time of The Last Quantifiable Concentration (AUC0-t) of EA5
Time frame: Baseline up to Week 14
Area Under The Serum Concentration Versus Time Curve From Time Zero (Dosing) To Infinity (AUCinf) of EA5
Time frame: Baseline up to Week 14
Terminal Elimination Rate Constant (λz) of Serum EA5
Time frame: Baseline up to Week 14
Terminal Elimination Half-life (t½) of Serum EA5
Time frame: Baseline up to Week 14
Total Clearance (CL) of EA5
Time frame: Baseline up to Week 14
Percent Change From Baseline in Free Complement Component 5 (C5)
Time frame: Baseline up to Week 14
Percent Change From Baseline in Total Complement C5
Time frame: Baseline up to Week 14
Percent Change From Baseline in determination of terminal complement activity in serum
Time frame: Baseline up to Week 14
Percentage of Participants With Positive Anti-Drug Antibody (ADA)
Time frame: Baseline up to Week 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- 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.
Fengkui Zhang, Dr. principal investigator
The Institute of Hematology & Blood Diseases Hospital (Chinese Academy of Medical Sciences)
Hongyan Tong, Dr. principal investigator
The First Affiliated Hospital, Zhejiang University School of Medicine, Chengzhan Campus
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EA5 in people with PNH - Paroxysmal Nocturnal Hemoglobinuria, run by Shanghai Lanyi Therapeutics Co., Ltd. at 2 sites 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 15 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fengkui zhang, Dr. (+86-022-23909999, zhfk@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (time frame: Baseline up to Week 14). 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 14 May 2026.