A Open Label Study to Determine the Safety, Tolerability and Pharmacokinetics of STC3141 Administered as an Infusion for up to 72 hours in Subjects in an Intensive Care Unit
- Conditions
- sepsisInflammatory and Immune System - Other inflammatory or immune system disordersInfection - Other infectious diseases
- Registration Number
- ACTRN12620000716965
- Lead Sponsor
- Grand Medical Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 26
1..Aged 18 to 85 years (inclusive at the time of informed consent);
2..Confirmed or suspected infection originating from any source;
3..Initiation of antibiotics;
4..Subjects with the sepsis-associated organ dysfunction as identified by a total Sequential Organ Failure Assessment (SOFA) score greater or equal 2 points;
5. ICU admission time is < 72 hours prior to infusion.
1. Subjects not expected to survive 24 hours;
2. Subjects who require a therapeutic dose of heparin or who are receiving oral anticoagulants, or received warfarin, factor Xa inhibitors within last 24 hours;
3. Subjects who have Absolute Neutrophil Count (ANC) less than 1000/mL;
4. Subjects who have activated Partial Thromboplastin Time (aPTT) greater than 55 s;
5. Severe anaemia (haemoglobin 6. Bleeding in the past 24 hours requiring blood transfusion;
7. Large area thermal burns or chemical burns (III-degree burns area greater than 30% Body Surface Area);
8. Solid organ or bone marrow transplantation within 4 weeks;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of AE and SAEs by severity graded by CTCAE 5.0[Day 8 post start-of-infusion];Incidence of treatment discontinuation due to AEs by data linked to discontinuation[Day 8 post start-of-infusion]
- Secondary Outcome Measures
Name Time Method Plasma PK parameters including Cmax, Tmax, Kel, AUC0-t, AUC0-inf, t1/2, CL, AUMC0-t, AUMC0-inf, MRT, Vss, [Blood samples for PK analysis will be collected within 2 hours prior to the start of the IP infusion, and at 12, 24 and 48 hours (±30 minutes) from the start of infusion, within 10 minutes before the EOI and 1(±2 minutes), 6 and 12 (±10 minutes), 24, 48, 72 and 120 hours (±30 minutes) post infusion.];Urine PK parameters including Ae0-t, fe and CLr.[All urine excreted by each subject will be collected for urine PK analysis, pooled, and the volume measured at the following intervals: a spot sample within 2 hours prior to the start of the IP infusion, and at 0-12, 12-24, 24-48, 48-72, 72-96, 96-120, and 120-144 hours from the start of infusion. At the end of each collection interval, record the total volume of sample pooled. Promptly mix pooled urine thoroughly and use a disposable plastic pipette to transfer at least 1 mL of sample into two 1.8 mL cryotubes (one A aliquot, one B aliquot). ]