None listed
Conditions
Brief summary
Septic patients often present renal dysfunction,, while it is important to figure it out the safety coverage and dose adjustment for these patients. This is a dose-adjusted, open-label, multi-centre study to determine the safety, tolerability and PK of STC3141 administered as a continuous IV infusion of up to 72 hours in subjects with sepsis and normal or compromised renal function in an ICU, where the rate of infusion is adjusted to account for calculated creatinine clearance. Four target steady state plasma concentrations (Css) are planned: 5µg/ml, 10µg/ml, 20 µg/mL and 25 µg/mL. Up to a total of 26 subjects will be enrolled into four (4) cohorts in the study, but numbers will depend on dose escalation/expansion decisions.
Interventions
The study drug is STC3141. The Investigator is responsible for the education of study staff as to the correct administration of the study drug. Once the study drug has been assigned to a subject it must not be reassigned to another subject. The study drug will be administered as a continuous IV infusion for up to 72 hours and shall be given as 3 x 100mLvolume sequentially over 24 hours via a dedicated infusion line. Each 100mL of study drug will be prepared daily in a bag, prior to use. An infus
The study drug is STC3141. The Investigator is responsible for the education of study staff as to the correct administration of the study drug. Once the study drug has been assigned to a subject it must not be reassigned to another subject. The study drug will be administered as a continuous IV infusion for up to 72 hours and shall be given as 3 x 100mLvolume sequentially over 24 hours via a dedicated infusion line. Each 100mL of study drug will be prepared daily in a bag, prior to use. An infusion pump set to a rate of 4.0 mL/hr will be used to administer the study drug. Four target steady state plasma concentrations (Css) are planned: 5µg/ml, 10µg/ml, 20 µg/mL and 25 µg/mL. (This is a pharmacokinetic guided design, so the infusion rate of each patients can be varied, which will be calculated based on their CrCL. This is a dose ascending study, with sequential cohorts only commencing upon satisfactory completion of the previous cohort. A subject may remain in the study but discontinue the infusion, at any time during treatment. Reason may include: • Protocol deviations or subject non compliance (must be specified on the appropriate eCRF) • Serious or severe AEs • Administrative decision by the Investigator or the Sponsor • Death • The subject is discharged from ICU • The subject requires a therapeutic heparin infusion to be commenced • The condition of the subject deteriorates to the point that active treatment is withdrawn • It is not in the subject’s best interests for the infusion to continue at the Investigators’ discretion • Withdrawal of consent by subject or their legal representatives
Sponsors
Grand Medical Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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 <less than 7.0 g/dL); 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;
Outcome results
None listed