GastroenterologyPhase 1NCT06515834
Investigating the Safety, Tolerability, Immunogenicity and Pharmacokinetics of Olamkicept in Healthy Japanese Persons
A Phase 1 study testing FE 999301 in people with Gastroenterology, run by Ferring Pharmaceuticals at 1 site in Japan.
Trial summary
Interleukin (IL)-6 is a cytokine produced in response to infection and tissue damage. IL-6 is believed to act as a key mediator in chronic inflammation and autoimmune diseases such as inflammatory bowel diseases. IL-6 is known to be involved in at least two distinct signalling pathways, classical and trans-signalling. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Gastroenterology
- What is being tested?
- FE 999301
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteJapan
- Study dates
- 1 Jul 2024to 28 Nov 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- In good health, determined by:
- no clinically significant findings from medical history,
- physical examination,
- 12-lead electrocardiogram (ECG),
- vital signs measurements,
- and clinical laboratory evaluations
Who cannot join
- History of clinically significant medical conditions including, but not limited to:
- diseases of the renal,
- hepatic,
- respiratory,
- gastrointestinal,
- cardiovascular,
Show all 16Show fewer
- neurological,
- musculoskeletal,
- immunological,
- haematological,
- endocrine,
- and metabolic systems,
- as well as oncological,
- psychiatric,
- dermatological,
- and allergic diseases (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Placebo-controlled, Within-group Randomised, and Double-blind Trial Investigating Safety, Tolerability, and Pharmacokinetics of FE 999301 After Single Ascending Doses in Healthy Japanese Men
Interleukin (IL)-6 is a cytokine produced in response to infection and tissue damage. IL-6 is believed to act as a key mediator in chronic inflammation and autoimmune diseases such as inflammatory bowel diseases. IL-6 is known to be involved in at least two distinct signalling pathways, classical and trans-signalling. The hypothesis is that classical signalling by IL-6 infers some beneficial effects (e.g. on gut barrier function), while excessive IL-6 trans-signalling may have detrimental effects. Olamkicept (FE 999301) has been shown in vitro to be a selective IL-6 trans-signalling inhibitor and administered at lower doses, it has proven to induce clinical improvement for patients with ulcerative colitis. The aim of this trial is to investigate safety, tolerability, immunogenicity and pharmacokinetics of Olamkicept at higher doses, to support the clinical development program. The hypothesis for this study is that treatment with higher doses of Olamkicept will result in greater clinical improvement for participants with inflammatory bowel diseases.
- Conditions
- Gastroenterology
- Being tested
- FE 999301, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FE 999301Drug
To assess the safety and tolerability of FE 999301 after single intravenous (IV) dose infusion in healthy Japanese men
PlaceboDrug
Placebo to assess the safety and tolerability of FE 999301 after single intravenous (IV) dose infusion in healthy Japanese men
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| FE 999301 | Active comparator | Not described Receives: Drug: FE 999301 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number treatment-emergent adverse events
Number of treatment-emergent adverse events, including type, intensity, and causality
Measured: From baseline up to 36 days after a single dose infusion
Blood pressure
Change from baseline in vital signs comprising systolic and diastolic blood pressure
Measured: From baseline up to 36 days after a single dose infusion
Pulse
Change from baseline in vital signs comprising pulse
Measured: From baseline up to 36 days after a single dose infusion
Body temperature
Change from baseline in vital signs comprising body temperature
Measured: From baseline up to 36 days after a single dose infusion
Heart rate
Change from baseline in 12-lead electrocardiogram (ECG) assessing heart rate after a single IV dose infusion.
Measured: From baseline up to 36 days after a single dose infusion
PR interval
Change from baseline in 12-lead electrocardiogram ECG assessing the PR interval after a single IV dose infusion.
Measured: From baseline up to 36 days after a single dose infusion
RR interval
Change from baseline in 12-lead ECG assessing the RR interval after a single IV dose infusion.
Measured: From baseline up to 36 days after a single dose infusion
QRS duration
Change from baseline in 12-lead ECG assessing QRS duration after a single IV dose infusion.
Measured: From baseline up to 36 days after a single dose infusion
QT interval
Change from baseline in 12-lead ECG assessing QT interval after a single IV dose infusion.
Measured: From baseline up to 36 days after a single dose infusion
QTc interval
Change from baseline in 12-lead electrocardiogram (ECG) assessing QTc interval after a single IV dose infusion.
Measured: From baseline up to 36 days after a single dose infusion
QRS axis
Change from baseline in 12-lead ECG assessing QRS axis after a single IV dose infusion.
Measured: From baseline up to 36 days after a single dose infusion
Change in haematology
Number of participants with clinically significant abnormal findings in haematology (haematocrit, haemoglobin, mean cellular volume (MCV), mean corpuscular haemoglobin content (MCHC), platelet count, red blood cell count, reticulocytes, white blood cell count with differential count, neutrophils, eosinophils, basophils, lymphocytes, monocytes) from baseline up to and including Day 36 after a single dose infusion.
Measured: From baseline up to 36 days after a single dose infusion
Clinical chemistry
Number of participants with clinically significant abnormal findings in clinical chemistry (alanine aminotranferase (ALT), albumin, alkaline phosphatase, aspartate aminotranferase (AST), glucose, calcium, chloride, cholesterol, C-reactive protein, creatinine, estimated glomerular filtration rate (eGFR), gamma-glutamyltranferase, phosphate, potassium, sodium, thyroid stimulating hormone, free triiodothyronine, free thyroxine, total bilirubin, urea (blood urea nitrogen)), from baseline up to and including Day 36 after a single dose infusion.
Measured: From baseline up to 36 days after a single dose infusion
Haemostasis
Blood and urine samples to assess change from baseline in haemostasis after a single IV dose infusion.
Measured: From baseline up to 36 days after a single dose infusion
Protein urinalysis parameter
Number of participants with clinically significant abnormal findings in protein urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.
Measured: From baseline up to 36 days after a single dose infusion
Glucose urinalysis parameter
Number of participants with clinically significant abnormal findings in glucose urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.
Measured: From baseline up to 36 days after a single dose infusion
Bilirubin urinalysis parameter
Number of participants with clinically significant abnormal findings in bilirubin urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.
Measured: From baseline up to 36 days after a single dose infusion
pH urinalysis parameter
Number of participants with clinically significant abnormal findings in pH urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.
Measured: From baseline up to 36 days after a single dose infusion
Nitrate urinalysis parameter
Number of participants with clinically significant abnormal findings in nitrate urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.
Measured: From baseline up to 36 days after a single dose infusion
Ketone urinalysis parameter
Number of participants with clinically significant abnormal findings in ketone urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.
Measured: From baseline up to 36 days after a single dose infusion
Urobilinogen urinalysis parameter
Number of participants with clinically significant abnormal findings in urobilinogen urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.
Measured: From baseline up to 36 days after a single dose infusion
Blood urinalysis parameter
Number of participants with clinically significant abnormal findings in blood urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.
Measured: From baseline up to 36 days after a single dose infusion
Leukocyte urinalysis parameter
Number of participants with clinically significant abnormal findings in leukocyte urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.
Measured: From baseline up to 36 days after a single dose infusion
Specific gravity urinalysis parameter
Number of participants with clinically significant abnormal findings in specific gravity urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.
Measured: From baseline up to 36 days after a single dose infusion
Secondary outcomes (9)
Area under the Curve to Infinity (AUCinf)
Single-dose Pharmacokinetics of FE 999301 evaluating the AUCinf after single IV dose infusion in healthy Japanese men.
Measured: From baseline up to 36 days after a single dose infusion
Area Under the Curve last concentration (AUClast)
Single-dose Pharmacokinetics of FE 999301 evaluating AUClast after single IV dose infusion in healthy Japanese men.
Measured: From baseline up to 36 days after a single dose infusion
Concentration at the end of infusion (Ceoi)
Single-dose Pharmacokinetics of FE 999301 assessing Ceoi after single IV dose infusion in healthy Japanese men.
Measured: From baseline up to 36 days after a single dose infusion
Maximum concentration (Cmax)
Single-dose Pharmacokinetics of FE 999301 evaluating maximum concentration in the body Cmax after a single IV dose infusion in healthy Japanese men.
Measured: From baseline up to 36 days after a single dose infusion
Time to reach maximum concentration (tmax)
Single-dose Pharmacokinetics of FE 999301 evaluating time to reach the maximum concentration in the body after a single IV dose infusion in healthy Japanese men.
Measured: From baseline up to 36 days after a single dose infusion
Elimination half-life (t1/2)
Single-dose Pharmacokinetics of FE 999301 evaluating the amount of time required for the drug concentration to be reduced to exactly half of its initial concentration in the blood after single IV dose infusion in healthy Japanese men.
Measured: From baseline up to 36 days after a single dose infusion
Mean residence time (MRT)
Single-dose Pharmacokinetics of FE 999301 assessing the average time the drug stays in the body after single IV dose infusion in healthy Japanese men.
Measured: From baseline up to 36 days after a single dose infusion
Clearance (CL)
Single-dose Pharmacokinetics of FE 999301 evaluating the rate at which the drug is removed from the body after single IV dose infusion in healthy Japanese men.
Measured: From baseline up to 36 days after a single dose infusion
Volume of Distribution at steady state (Vss)
Single-dose Pharmacokinetics of FE 999301 assessing the volume of distribution at a steady state after single IV dose infusion in healthy Japanese men.
Measured: From baseline up to 36 days after a single dose infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start1 Jul 2024
- Primary completion28 Nov 2024
- Study completion28 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GastroenterologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Compliance, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06515834
- Sponsor's protocol ID
- 000435
- Status last verified
- Jul 2024
- First submitted
- 1 Jul 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hanada R, Bruzelius K, Falkenberg M, Kyhl LE, Mogelmose S, Ravi A, Pinton P, Yoneshima N. Safety and Pharmacokinetics of Olamkicept Doses up to 2400 mg in Healthy Japanese Men: Phase I, Randomized, Placebo-Controlled, and Double-Blind Trial. Clin Transl Sci. 2026 Aug;19(8):e70673. doi: 10.1111/cts.70673.
PubMed 42503008
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled, Within-group Randomised, and Double-blind Trial Investigating Safety, Tolerability, and Pharmacokinetics of FE 999301 After Single Ascending Doses in Healthy Japanese Men
- ClinicalTrials.gov ID
- NCT06515834
- Acronym / sponsor ID
- 000435
- Conditions
- Gastroenterology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 28 Nov 2024 (actual)
- Study completion
- 28 Nov 2024 (actual)
- First posted
- 23 Jul 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.
Interleukin (IL)-6 is a cytokine produced in response to infection and tissue damage. IL-6 is believed to act as a key mediator in chronic inflammation and autoimmune diseases such as inflammatory bowel diseases. IL-6 is known to be involved in at least two distinct signalling pathways, classical and trans-signalling. The hypothesis is that classical signalling by IL-6 infers some beneficial effects (e.g. on gut barrier function), while excessive IL-6 trans-signalling may have detrimental effects. Olamkicept (FE 999301) has been shown in vitro to be a selective IL-6 trans-signalling inhibitor and administered at lower doses, it has proven to induce clinical improvement for patients with ulcerative colitis. The aim of this trial is to investigate safety, tolerability, immunogenicity and pharmacokinetics of Olamkicept at higher doses, to support the clinical development program. The hypothesis for this study is that treatment with higher doses of Olamkicept will result in greater clinical improvement for participants with inflammatory bowel diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| FE 999301 | Active comparator | Drug: FE 999301 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- In good health, determined by:
Key exclusion criteria (16 listed)
- History of clinically significant medical conditions including, but not limited to:
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 |
|---|---|---|
| FE 999301To assess the safety and tolerability of FE 999301 after single intravenous (IV) dose infusion in healthy Japanese men | Drug | FE 999301 |
| PlaceboPlacebo to assess the safety and tolerability of FE 999301 after single intravenous (IV) dose infusion in healthy Japanese men | Drug | Placebo |
Primary outcome
Number treatment-emergent adverse events
Time frame: From baseline up to 36 days after a single dose infusion
Number of treatment-emergent adverse events, including type, intensity, and causality
Blood pressure
Time frame: From baseline up to 36 days after a single dose infusion
Change from baseline in vital signs comprising systolic and diastolic blood pressure
Pulse
Time frame: From baseline up to 36 days after a single dose infusion
Change from baseline in vital signs comprising pulse
Body temperature
Time frame: From baseline up to 36 days after a single dose infusion
Change from baseline in vital signs comprising body temperature
Heart rate
Time frame: From baseline up to 36 days after a single dose infusion
Change from baseline in 12-lead electrocardiogram (ECG) assessing heart rate after a single IV dose infusion.
PR interval
Time frame: From baseline up to 36 days after a single dose infusion
Change from baseline in 12-lead electrocardiogram ECG assessing the PR interval after a single IV dose infusion.
RR interval
Time frame: From baseline up to 36 days after a single dose infusion
Change from baseline in 12-lead ECG assessing the RR interval after a single IV dose infusion.
QRS duration
Time frame: From baseline up to 36 days after a single dose infusion
Change from baseline in 12-lead ECG assessing QRS duration after a single IV dose infusion.
QT interval
Time frame: From baseline up to 36 days after a single dose infusion
Change from baseline in 12-lead ECG assessing QT interval after a single IV dose infusion.
QTc interval
Time frame: From baseline up to 36 days after a single dose infusion
Change from baseline in 12-lead electrocardiogram (ECG) assessing QTc interval after a single IV dose infusion.
QRS axis
Time frame: From baseline up to 36 days after a single dose infusion
Change from baseline in 12-lead ECG assessing QRS axis after a single IV dose infusion.
Change in haematology
Time frame: From baseline up to 36 days after a single dose infusion
Number of participants with clinically significant abnormal findings in haematology (haematocrit, haemoglobin, mean cellular volume (MCV), mean corpuscular haemoglobin content (MCHC), platelet count, red blood cell count, reticulocytes, white blood cell count with differential count, neutrophils, eosinophils, basophils, lymphocytes, monocytes) from baseline up to and including Day 36 after a single dose infusion.
Clinical chemistry
Time frame: From baseline up to 36 days after a single dose infusion
Number of participants with clinically significant abnormal findings in clinical chemistry (alanine aminotranferase (ALT), albumin, alkaline phosphatase, aspartate aminotranferase (AST), glucose, calcium, chloride, cholesterol, C-reactive protein, creatinine, estimated glomerular filtration rate (eGFR), gamma-glutamyltranferase, phosphate, potassium, sodium, thyroid stimulating hormone, free triiodothyronine, free thyroxine, total bilirubin, urea (blood urea nitrogen)), from baseline up to and including Day 36 after a single dose infusion.
Haemostasis
Time frame: From baseline up to 36 days after a single dose infusion
Blood and urine samples to assess change from baseline in haemostasis after a single IV dose infusion.
Protein urinalysis parameter
Time frame: From baseline up to 36 days after a single dose infusion
Number of participants with clinically significant abnormal findings in protein urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.
Glucose urinalysis parameter
Time frame: From baseline up to 36 days after a single dose infusion
Number of participants with clinically significant abnormal findings in glucose urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.
Bilirubin urinalysis parameter
Time frame: From baseline up to 36 days after a single dose infusion
Number of participants with clinically significant abnormal findings in bilirubin urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.
pH urinalysis parameter
Time frame: From baseline up to 36 days after a single dose infusion
Number of participants with clinically significant abnormal findings in pH urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.
Nitrate urinalysis parameter
Time frame: From baseline up to 36 days after a single dose infusion
Number of participants with clinically significant abnormal findings in nitrate urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.
Ketone urinalysis parameter
Time frame: From baseline up to 36 days after a single dose infusion
Number of participants with clinically significant abnormal findings in ketone urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.
Urobilinogen urinalysis parameter
Time frame: From baseline up to 36 days after a single dose infusion
Number of participants with clinically significant abnormal findings in urobilinogen urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.
Blood urinalysis parameter
Time frame: From baseline up to 36 days after a single dose infusion
Number of participants with clinically significant abnormal findings in blood urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.
Leukocyte urinalysis parameter
Time frame: From baseline up to 36 days after a single dose infusion
Number of participants with clinically significant abnormal findings in leukocyte urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.
Specific gravity urinalysis parameter
Time frame: From baseline up to 36 days after a single dose infusion
Number of participants with clinically significant abnormal findings in specific gravity urinalysis parameter from baseline up to and including Day 36 after a single dose infusion.
9 secondary outcomes
Area under the Curve to Infinity (AUCinf)
Time frame: From baseline up to 36 days after a single dose infusion
Area Under the Curve last concentration (AUClast)
Time frame: From baseline up to 36 days after a single dose infusion
Concentration at the end of infusion (Ceoi)
Time frame: From baseline up to 36 days after a single dose infusion
Maximum concentration (Cmax)
Time frame: From baseline up to 36 days after a single dose infusion
Time to reach maximum concentration (tmax)
Time frame: From baseline up to 36 days after a single dose infusion
Elimination half-life (t1/2)
Time frame: From baseline up to 36 days after a single dose infusion
Mean residence time (MRT)
Time frame: From baseline up to 36 days after a single dose infusion
Clearance (CL)
Time frame: From baseline up to 36 days after a single dose infusion
Volume of Distribution at steady state (Vss)
Time frame: From baseline up to 36 days after a single dose infusion
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 6 Dec 2024.
- Derived from this study: PubMed 42503008Hanada R, Bruzelius K, Falkenberg M, Kyhl LE, Mogelmose S, Ravi A, Pinton P, Yoneshima N. Safety and Pharmacokinetics of Olamkicept Doses up to 2400 mg in Healthy Japanese Men: Phase I, Randomized, Placebo-Controlled, and Double-Blind Trial. Clin Transl Sci. 2026 Aug;19(8):e70673. doi: 10.1111/cts.70673.
- 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.
Global Clinical Compliance study director
Ferring Pharmaceuticals
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 FE 999301 in people with Gastroenterology, run by Ferring Pharmaceuticals at 1 site in Japan.
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 6 inclusion and 16 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 6 Dec 2024. 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 Japan. 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 treatment-emergent adverse events (time frame: From baseline up to 36 days after a single dose infusion). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06515834, which also lists 1 linked publication.
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 6 Dec 2024.