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 to
understand 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 the
study 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 and
be 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 per
Investigator assessment.

- No known increase in SCr of ≥25% at screening visit compared to a previous value
obtained within the last 6 months as documented by a local laboratory using standard
assay methodology.

- Non-emergent open chest cavity major cardiopulmonary bypass (CPB) surgery with
expected 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 prior
to screening.

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

- History of bleeding with suspected or confirmed bleeding disorder or any other
high risk for bleeding in the opinion of the investigator

- Thrombocytopenia: platelet count< 100x109/L

- History of platelet dysfunction: e.g., ADP induced platelet aggregation lower
than 60 %

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

- Any emergency surgeries performed less than 30 days before screening, including
aortic 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-aortic
balloon counter-pulsation (IABP).

- Have received cardiopulmonary resuscitation (CPR) within 30 days prior to cardiac
surgery.

- Use of other investigational drugs at the time of enrollment, or within 5 half-lives
of enrollment, or until the expected PD effect has returned to baseline, whichever
is 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 untreated
diagnosed infection prior to screening visit. Sepsis is defined as presence of a
confirmed pathogen, along with fever or hypothermia, and hypoperfusion or
hypotension.

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

- Pregnant or nursing (lactating) women

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

- Total abstinence (when this is in line with the preferred and usual lifestyle
of the participant. Periodic abstinence (e.g. calendar, symptothermal and
post-ovulation methods) and withdrawal are not acceptable methods of
contraception.

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

- Male sterilization (at least 6 months prior to screening). For female
participants on the study, the vasectomized male partner should be the sole
partner for that participant.

- Use of oral (estrogen and progesterone), injected, or implanted hormonal
methods of contraception or placement of an intrauterine device (IUD) or
intrauterine system (IUS), or other forms of hormonal contraception that have
comparable efficacy (failure rate < 1%), for example hormone vaginal ring or
transdermal hormone contraception.