A Multi-center Study to Evaluate the Safety, Tolerability and Efficacy of TIN816 in Patients at Risk for Acute Kidney Injury Following Cardiac Surgery.

Inclusion Criteria:

• Signed informed consent must be obtained prior to participation in the study.

• Participants must be able to communicate well with the investigator and tounderstand and comply with the requirements of the study.

• Male and female patients ≥45 years at screening.

• Participants must weigh at least 50 kg and maximum 150 kg to participate in thestudy and must have a body mass index (BMI) below 40. BMI = Body weight (kg) / [Height (m)]2.

• At screening, vital signs should be assessed in the sitting or supine position andbe within the following ranges:

1. body temperature between 35.0-37.5 °C

2. blood pressure (systolic 100-160 mmHg, diastolic < 100 mmHg)

3. pulse rate (50-100/min) stable with or without medication(s) as perInvestigator assessment.

• No known increase in SCr of ≥25% at screening visit compared to a previous valueobtained within the last 6 months as documented by a local laboratory using standardassay methodology.

• Non-emergent open chest cavity major cardiopulmonary bypass (CPB) surgery withexpected CPB time ≥1 hour

Exclusion Criteria:

• eGFR at screening <15 mL/min/1.73 m2 (calculated using CKD-EPI 2021 equation).

• Receiving renal replacement therapy currently or at any time within 3 months priorto screening.

• Patients with bleeding risk at screening. The Investigator should make thisdetermination in consideration of the participant's medical history and/or clinicalor laboratory evidence of any of the following:

• History of bleeding with suspected or confirmed bleeding disorder or any otherhigh risk for bleeding in the opinion of the investigator

• Thrombocytopenia: platelet count< 100x109/L

• History of platelet dysfunction: e.g., ADP induced platelet aggregation lowerthan 60 %

• History of coagulation factor deficiency: including, but not limited tofibrinogen ≤ 2.5 g/L or Von Willebrand factor (vWF) ≤ 50 IU/dL

• Any emergency surgeries performed less than 30 days before screening, includingaortic dissection, and/or major congenital heart defects.

• Scheduled to undergo cardiac surgery off CPB or with hypothermic circulatory arrest.

• Cardiogenic shock or hemodynamic instability within four weeks prior to surgery,requiring inotropes or vasopressors or mechanical devices such as intra-aorticballoon counter-pulsation (IABP).

• Have received cardiopulmonary resuscitation (CPR) within 30 days prior to cardiacsurgery.

• Use of other investigational drugs at the time of enrollment, or within 5 half-livesof enrollment, or until the expected PD effect has returned to baseline, whicheveris longer; or longer if required by local regulations.

• Patients who are post-nephrectomy

• Have ongoing sepsis or history of sepsis within the past 8 weeks or untreateddiagnosed infection prior to screening visit. Sepsis is defined as presence of aconfirmed pathogen, along with fever or hypothermia, and hypoperfusion orhypotension.

• Recent (within the last three years) and/or recurrent history of autonomicdysfunction (e.g., recurrent episodes of fainting, palpitations, etc.).

• Pregnant or nursing (lactating) women

• Women of child-bearing potential, defined as all women physiologically capable ofbecoming pregnant, unless they are using highly effective methods of contraceptionwhile taking study treatment and until the end of study. Highly effectivecontraception methods include:

• Total abstinence (when this is in line with the preferred and usual lifestyleof the participant. Periodic abstinence (e.g. calendar, symptothermal andpost-ovulation methods) and withdrawal are not acceptable methods ofcontraception.

• Female bilateral tubal ligation, female sterilization (have had surgicalbilateral oophorectomy with or without hysterectomy) or total hysterectomy atleast six weeks before taking study treatment. In case of oophorectomy alone,only when the reproductive status of the woman has been confirmed by follow uphormone level assessment.

• Male sterilization (at least 6 months prior to screening). For femaleparticipants on the study, the vasectomized male partner should be the solepartner for that participant.

• Use of oral (estrogen and progesterone), injected, or implanted hormonalmethods of contraception or placement of an intrauterine device (IUD) orintrauterine system (IUS), or other forms of hormonal contraception that havecomparable efficacy (failure rate < 1%), for example hormone vaginal ring ortransdermal hormone contraception.