Acute Kidney Injury Due to SepsisPhase 2NCT05507437
Pharmacokinetics and Safety of TIN816 in Patients With Sepsis-associated Acute Kidney Injury
A Phase 2 study testing TIN816 70 mg lyophilisate powder in people with Acute Kidney Injury Due to Sepsis, run by Novartis Pharmaceuticals at 7 sites in 5 countries.
Trial summary
The purpose of this study was to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile and to evaluate the safety and tolerability of TIN816 in hospitalized adult participants in an intensive care setting with a diagnosis of sepsis-associated acute kidney injury (SA-AKI). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Kidney Injury Due to Sepsis
- What is being tested?
- TIN816 70 mg lyophilisate powder
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 7 sitesin 5 countries
- Study dates
- 22 Nov 2022to 25 Apr 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent must be obtained prior to participation in the study.
- ≥ 18 and ≤ 85 years of age.
- Admitted to ICU or intermediate/HDU.
- Diagnosis of sepsis according to criteria defined by The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) based on:
- Suspected or confirmed infection SOFA score of 2 or more (excluding renal component)
- Diagnosis of AKI Stage 1 or greater per the following criterion at randomization :
Show all 11Show fewer
- An absolute increase in serum or plasma creatinine (CR) by ≥0.3 mg/dL (≥26.5 µmol/L) within 48 hours or presumed to have occurred in the previous 48 hours as compared to the reference creatinine baseline.
- For hospital-acquired AKI, a stable serum creatinine obtained in the hospital prior to AKI should be used as reference baseline, otherwise, baseline serum creatinine in the following order of preference:
- Median value within 3 months of the hospital admission. If not available:
- Median value between 3 and 6 months prior to hospital admission. If not available:
- At hospital admission.
Who cannot join
- Not expected to survive for 24 hours.
- Not expected to survive for 30 days due to medical conditions other than SA-AKI.
- History of CKD with a documented estimated GFR <45 ml/min prior to development of AKI.
- Receiving RRT or a decision has been made to initiate RRT within 24 hours of admission.
- Weight is less than 40 kg or more than 125 kg .
- Has life support limitations (eg, do not resuscitate, do not dialyze, do not intubate).
Show all 26Show fewer
- AKI diagnosis according to the AKI inclusion criteria for a period longer than 48 hours prior to study drug administration.
- Presence of AKI for a period longer than 48 hours prior to study drug administration as suggested by clinical manifestations, e.g., prolonged oliguria or severe renal dysfunction (eg, serum creatinine > 4 mg/dL) on admission without a history of CKD.
- Evidence of recovery from AKI based on the investigator's clinical judgement prior to randomization.
- AKI is most likely attributable to causes other than sepsis such as nephrotoxic drugs (Non-steroidal anti-inflammatory drugs (NSAIDs), contrast, aminoglycosides), other medical conditions (e.g. heart failure, liver failure, acute abdominal aortic aneurysm, dissection, renal artery stenosis) or urinary obstruction.
- Documented (biopsy proven) or suspected history of acute or sub-acute kidney diseases such as rapidly progressive glomerular nephritis (RPGN) and acute interstitial nephritis (AIN).
- Patients who are post-nephrectomy.
- Patients who are on dual antiplatelet therapy.
- Patients who are thrombocytopenic at screening (Platelet count <100,000 microliter) or other high risk for bleeding in the opinion of the investigator.
- Immunosuppressed patients:
- History of immunodeficiency diseases or known HIV test positive. Is receiving immunosuppressant treatment or is on chronic high doses (high-dose therapy exceeding 2 weeks of treatment) of steroids equivalent to prednisone/prednisolone 0.5 mg/kg/day, including solid organ transplant patients. Patients with septic shock treated with hydrocortisone (e.g., 3 × 100 mg) can be included.
- Active hepatitis (defined as (a) abnormal liver enzymes (Alanine aminotransferase (ALT), Gamma-glutamyl transferase (GGT), ALP > 3x Upper Limit of Normal (ULN) or (b)) for active hepatitis B or C infection, a positive Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) serology or patients with advanced chronic liver disease, confirmed by a Child-Pugh score of 10-15 (Class C).
- Acute pancreatitis with no established source of infection.
- Active hematological malignancy (previous hematological malignancies that are not actively treated are allowable).
- Burns requiring ICU treatment.
- Sepsis attributed to confirmed COVID-19.
- Use of other investigational drugs within 5 half-lives of enrollment within 30 days (e.g., small molecules) / or until the expected pharmacodynamic effect has returned to baseline (e.g., biologics), whichever is longer; or longer if required by local regulations.
- History of hypersensitivity to the study treatment or its excipients or to drugs of similar chemical classes.
- Any medical conditions that could significantly increase risk of participants' safety by participating in this study according to investigator's judgement.
- Women with a positive pregnancy test, pregnancy or breast feeding.
- Women of child-bearing potential
Trial locations and contacts
7 sites in 5 countries.
7 sites in 5 countries
Belgium2 sites
Novartis Investigative Site
Genk, 3600
Novartis Investigative Site
Ottignies, 1340
France2 sites
Novartis Investigative Site
Strasbourg, 67091
Novartis Investigative Site
Toulouse, 31054
About this study
Official title: A Participant and Investigator-blinded, Randomized, Placebo-controlled Phase 2a Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of TIN816 in Patients With Sepsis-associated Acute Kidney Injury
The purpose of this study was to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile and to evaluate the safety and tolerability of TIN816 in hospitalized adult participants in an intensive care setting with a diagnosis of sepsis-associated acute kidney injury (SA-AKI).
Read the detailed description
This was a multicenter, participant and investigator-blinded, randomized, placebo-controlled study to characterize PK/PD profile and to evaluate the safety and the tolerability of TIN816. The study enrolled hospitalized adult participants with a diagnosis of sepsis and acute kidney injury (AKI). 20 participants were randomized in the study. The study consisted of a screening period (24-48 hours), a treatment period (day 1), and post-treatment period (days 2 to 90).
Screening took place during hospitalization in a intensive care unit (ICU) (or intermediate/high dependency unit (HDU care) where potential participants were undergo screening to assess the presence of sepsis and AKI. Pre-identified participants provided informed consent and went to screening assessments to determine eligibility. Potential study candidates were hospitalized patients with a diagnosis of sepsis based on Sepsis 3 criteria with suspected or confirmed infection and SOFA score ≥ 2 after excluding the renal component, and a diagnosis of AKI stage 1 or greater. At Treatment Day 1, participants who meet eligibility criteria at screening and baseline were randomized in a 3:1 ratio to treatment with TIN816 or placebo by intravenous infusion in a participant and investigator-blinded fashion.
Treatment day 1 was followed by a 90 day post-treatment period for pharmocokinetic, pharmacodynamic, safety and tolerability assessments.
- Conditions
- Acute Kidney Injury Due to Sepsis
- Being tested
- TIN816 70 mg lyophilisate powder, Placebo
- Keywords
- Sepsis, acute kidney injury, intensive care, therapy
- Medical subject headings
- Sepsis, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIN816 70 mg lyophilisate powderBiological
Recombinant human CD39 enzyme
PlaceboOther
0.9% sterile sodium chloride solution
| Study group | Role | What they receive |
|---|---|---|
| TIN816 | Experimental | Administered as an intravenous dose Receives: Biological: TIN816 70 mg lyophilisate powder |
| Placebo | Placebo comparator | 0.9% sterile sodium chloride solution administered as an intravenous dose Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Serum Concentration (Cmax) of TIN816
Cmax is defined as the maximum (peak) observed concentration following a dose. TIN816 serum concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8.3). TIN816 concentrations were determined by a validated ligand binding assay with a lower limit of quantification (LLOQ) of 10 ng/mL.
Measured: Day 1 (Pre-dose and 2 hours), Day 2, Day 3, Day 5, Day 8, Day 14, Day 30, Day 60 and Day 90
Area Under Serum Concentration-time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) of TIN816
AUClast is the area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (tlast) of TIN816. TIN816 serum concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8.3). TIN816 concentrations were determined by a validated ligand binding assay with a lower limit of quantification (LLOQ) of 10 ng/mL.
Measured: Day 1 (Pre-dose and 2 hours), Day 2, Day 3, Day 5, Day 8, Day 14, Day 30, Day 60 and Day 90
Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0-inf]) of TIN816
The AUC from time zero to infinity (mass x time x volume-1). TIN816 serum concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8.3). TIN816 concentrations were determined by a validated ligand binding assay with a lower limit of quantification (LLOQ) of 10 ng/mL.
Measured: Day 1 (Pre-dose and 2 hours), Day 2, Day 3, Day 5, Day 8, Day 14, Day 30, Day 60 and Day 90
Time to Reach Maximum Serum Concentration (Tmax) of TIN816
Tmax is the time to reach maximum (peak) drug concentration after single-dose administration (time). TIN816 serum concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8.3). TIN816 concentrations were determined by a validated ligand binding assay with a lower limit of quantification (LLOQ) of 10 ng/mL.
Measured: Day 1 (Pre-dose and 2 hours), Day 2, Day 3, Day 5, Day 8, Day 14, Day 30, Day 60 and Day 90
Terminal Elimination Half-life (T1/2) of TIN816
T1/2 is the elimination half-life associated with the terminal slope. TIN816 serum concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8.3). TIN816 concentrations were determined by a validated ligand binding assay with a lower limit of quantification (LLOQ) of 10 ng/mL.
Measured: Day 1 (Pre-dose and 2 hours), Day 2, Day 3, Day 5, Day 8, Day 14, Day 30, Day 60 and Day 90
Total Body Clearance (CL) of TIN816
CL is the total body clearance of TIN816 from the serum following intravenous administration (volume x time-1). TIN816 serum concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8.3). TIN816 concentrations were determined by a validated ligand binding assay with a lower limit of quantification (LLOQ) of 10 ng/mL.
Measured: Day 1 (Pre-dose and 2 hours), Day 2, Day 3, Day 5, Day 8, Day 14, Day 30, Day 60 and Day 90
The Apparent Volume of Distribution (Vz) of TIN816
Vz is the apparent volume of distribution during terminal phase following intravenous administration. TIN816 serum concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8.3). TIN816 concentrations were determined by a validated ligand binding assay with a lower limit of quantification (LLOQ) of 10 ng/mL.
Measured: Day 1 (Pre-dose and 2 hours), Day 2, Day 3, Day 5, Day 8, Day 14, Day 30, Day 60 and Day 90
Secondary outcomes (1)
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with treatment emergent AEs (any AE regardless of seriousness) and SAEs.
Measured: Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start22 Nov 2022
- Primary completion25 Apr 2024
- Study completion25 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Kidney Injury Due to SepsisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05507437
- Sponsor's protocol ID
- CTIN816B12201
- Other IDs
- 2022-000887-23
- Status last verified
- Nov 2025
- First submitted
- 17 Aug 2022
- Last updated
- 4 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Participant and Investigator-blinded, Randomized, Placebo-controlled Phase 2a Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of TIN816 in Patients With Sepsis-associated Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT05507437
- Acronym / sponsor ID
- CTIN816B12201
- Conditions
- Acute Kidney Injury Due to Sepsis
- Keywords
- Sepsis, acute kidney injury, intensive care, therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 25 Apr 2024 (actual)
- Study completion
- 25 Apr 2024 (actual)
- First posted
- 19 Aug 2022 (actual)
- Results
- Posted 1 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile and to evaluate the safety and tolerability of TIN816 in hospitalized adult participants in an intensive care setting with a diagnosis of sepsis-associated acute kidney injury (SA-AKI).
Detailed description
This was a multicenter, participant and investigator-blinded, randomized, placebo-controlled study to characterize PK/PD profile and to evaluate the safety and the tolerability of TIN816. The study enrolled hospitalized adult participants with a diagnosis of sepsis and acute kidney injury (AKI). 20 participants were randomized in the study. The study consisted of a screening period (24-48 hours), a treatment period (day 1), and post-treatment period (days 2 to 90).
Screening took place during hospitalization in a intensive care unit (ICU) (or intermediate/high dependency unit (HDU care) where potential participants were undergo screening to assess the presence of sepsis and AKI. Pre-identified participants provided informed consent and went to screening assessments to determine eligibility. Potential study candidates were hospitalized patients with a diagnosis of sepsis based on Sepsis 3 criteria with suspected or confirmed infection and SOFA score ≥ 2 after excluding the renal component, and a diagnosis of AKI stage 1 or greater. At Treatment Day 1, participants who meet eligibility criteria at screening and baseline were randomized in a 3:1 ratio to treatment with TIN816 or placebo by intravenous infusion in a participant and investigator-blinded fashion.
Treatment day 1 was followed by a 90 day post-treatment period for pharmocokinetic, pharmacodynamic, safety and tolerability assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIN816 | Experimental | Biological: TIN816 70 mg lyophilisate powderAdministered as an intravenous dose |
| Placebo | Placebo comparator | Other: Placebo0.9% sterile sodium chloride solution administered as an intravenous dose |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed informed consent must be obtained prior to participation in the study.
- ≥ 18 and ≤ 85 years of age.
- Admitted to ICU or intermediate/HDU.
- Diagnosis of sepsis according to criteria defined by The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) based on:
- Suspected or confirmed infection SOFA score of 2 or more (excluding renal component)
Key exclusion criteria (26 listed)
- Not expected to survive for 24 hours.
- Not expected to survive for 30 days due to medical conditions other than SA-AKI.
- History of CKD with a documented estimated GFR <45 ml/min prior to development of AKI.
- Receiving RRT or a decision has been made to initiate RRT within 24 hours of admission.
- Weight is less than 40 kg or more than 125 kg .
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 |
|---|---|---|
| TIN816 70 mg lyophilisate powderRecombinant human CD39 enzyme | Biological | TIN816 |
| Placebo0.9% sterile sodium chloride solution | Other | Placebo |
Primary outcome
Maximum Serum Concentration (Cmax) of TIN816
Time frame: Day 1 (Pre-dose and 2 hours), Day 2, Day 3, Day 5, Day 8, Day 14, Day 30, Day 60 and Day 90
Cmax is defined as the maximum (peak) observed concentration following a dose. TIN816 serum concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8.3). TIN816 concentrations were determined by a validated ligand binding assay with a lower limit of quantification (LLOQ) of 10 ng/mL.
Area Under Serum Concentration-time Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) of TIN816
Time frame: Day 1 (Pre-dose and 2 hours), Day 2, Day 3, Day 5, Day 8, Day 14, Day 30, Day 60 and Day 90
AUClast is the area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (tlast) of TIN816. TIN816 serum concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8.3). TIN816 concentrations were determined by a validated ligand binding assay with a lower limit of quantification (LLOQ) of 10 ng/mL.
Area Under the Serum Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0-inf]) of TIN816
Time frame: Day 1 (Pre-dose and 2 hours), Day 2, Day 3, Day 5, Day 8, Day 14, Day 30, Day 60 and Day 90
The AUC from time zero to infinity (mass x time x volume-1). TIN816 serum concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8.3). TIN816 concentrations were determined by a validated ligand binding assay with a lower limit of quantification (LLOQ) of 10 ng/mL.
Time to Reach Maximum Serum Concentration (Tmax) of TIN816
Time frame: Day 1 (Pre-dose and 2 hours), Day 2, Day 3, Day 5, Day 8, Day 14, Day 30, Day 60 and Day 90
Tmax is the time to reach maximum (peak) drug concentration after single-dose administration (time). TIN816 serum concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8.3). TIN816 concentrations were determined by a validated ligand binding assay with a lower limit of quantification (LLOQ) of 10 ng/mL.
Terminal Elimination Half-life (T1/2) of TIN816
Time frame: Day 1 (Pre-dose and 2 hours), Day 2, Day 3, Day 5, Day 8, Day 14, Day 30, Day 60 and Day 90
T1/2 is the elimination half-life associated with the terminal slope. TIN816 serum concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8.3). TIN816 concentrations were determined by a validated ligand binding assay with a lower limit of quantification (LLOQ) of 10 ng/mL.
Total Body Clearance (CL) of TIN816
Time frame: Day 1 (Pre-dose and 2 hours), Day 2, Day 3, Day 5, Day 8, Day 14, Day 30, Day 60 and Day 90
CL is the total body clearance of TIN816 from the serum following intravenous administration (volume x time-1). TIN816 serum concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8.3). TIN816 concentrations were determined by a validated ligand binding assay with a lower limit of quantification (LLOQ) of 10 ng/mL.
The Apparent Volume of Distribution (Vz) of TIN816
Time frame: Day 1 (Pre-dose and 2 hours), Day 2, Day 3, Day 5, Day 8, Day 14, Day 30, Day 60 and Day 90
Vz is the apparent volume of distribution during terminal phase following intravenous administration. TIN816 serum concentrations were determined using the actual recorded sampling times and non-compartmental method with Phoenix WinNonlin (Version 8.3). TIN816 concentrations were determined by a validated ligand binding assay with a lower limit of quantification (LLOQ) of 10 ng/mL.
1 secondary outcome
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Adverse events were reported from first dose of study treatment until end of study treatment plus follow up period, up to a maximum duration of approximately 90 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A Plain Language Trial Summary is available on www.novctrd.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TIN816 70 mg lyophilisate powder in people with Acute Kidney Injury Due to Sepsis, run by Novartis Pharmaceuticals at 7 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 26 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 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Belgium, France, Germany, Hungary, Spain. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maximum Serum Concentration (Cmax) of TIN816 (time frame: Day 1 (Pre-dose and 2 hours), Day 2, Day 3, Day 5, Day 8, Day 14, Day 30, Day 60 and Day 90). The study lists 7 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 4 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.