Safety, tolerability, pharmacokinetics, and efficacy of kukoamine B in patients with sepsis: A randomized phase IIa trial
Authors' conclusion
In patients with sepsis-induced organ failure, KB was safe and well tolerated.
Study context
- Population
- Patients with sepsis-induced organ failureenrolled
- Participants
- 44 patients
- Comparison
- Kukoamine B vs placebo, every 8 h for 7 days
- Primary endpoint
- Safety
Methodological detailsphase IIa, multicentre, double-blind, placebo-controlled
- Phase IIa
- Multicentre
- Double-blind
- Placebo-controlled
Primary result
As reported in the abstract
Adverse events
Secondary outcomes
Death · 28-day follow-up
Pharmacokinetic (PK) parameters
- Dose-dependent drug exposure and no drug accumulation
Clinical outcomes (ΔSOFA score, vasopressor-free days, ventilator-free days)
- Kukoamine B (KB) did not affect clinical outcomes
Death · 28-day follow-up
- None related to study drug
Safety
Treatment emergent adverse events
Original publication
Safety, tolerability, pharmacokinetics, and efficacy of kukoamine B in patients with sepsis: A randomized phase IIa trial. J Crit Care. Published 26 April 2023. doi:10.
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