This is a Phase 1 study to assess the safety and tolerability of the liposomal product in healthy participants.
This is a Phase 1 clinical trial consisting of a dose-escalation and dose-expansion study to evaluate the safety, clinical tolerability, and pharmacokinetics of the intravenous liposomal dispersion product in healthy participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
liposome rescue
Daniele Hamamoto
Campinas, São Paulo, Brazil
Safety: Number of Treatment Related Adverse Events
The severity/intensity (grade 1 to grade 5) of adverse events will be assessed by the investigator as "unlikely," "possibly," or "probably" related to the investigational drug. An adverse event will be considered causally related to the use of the investigational drug when the causality assessment was "probable" or "possible."
Time frame: From enrollment to the end of treatment at 2 weeks.
Safety: Number of Clinically Significant (CS) Changes in Physical Examination.
A complete physical examination includes assessments of selected body systems, at the investigator's discretion, but covers at least the cardiovascular, pulmonary, and neurological systems. Examination results will be documented in the eCRF as normal, abnormal without clinical significance (CNS), or abnormal with clinical significance (CS). Post-dose physical examination findings classified as abnormal CS will be reported as adverse events (AEs).
Time frame: From enrollment to the end of treatment at 2 weeks.
Cmax
The Maximal Plasma Concentration (Cmax) after a single dose of liposome in fasting conditions.
Time frame: From time 0 (time of dosing) to 10,080 minutes after dose (concentration measured at timepoints pre-dose and 0; 5; 10; 15; 20; 40; 50; 60; 70; 90 120; 240; 360; 540; 720; 1,440; 2,160; 2,880 and 10,080 minutes post-dose).
AUC
AUC will be determined by evaluating the pharmacokinetic profile, in which the liposome in the blood will be quantified.
Time frame: From time 0 (time of dosing) to 10,080 minutes after dose (concentration measured at timepoints pre-dose and 0; 5; 10; 15; 20; 40; 50; 60; 70; 90 120; 240; 360; 540; 720; 1,440; 2,160; 2,880 and 10,080 minutes post-dose).
T1/2(z)
Plasma half-life associated with the terminal elimination phase (T1/2(z)) after a single dose of Liposome in fasting condition.
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Time frame: From time 0 (time of dosing) to 10,080 minutes after dose (concentration measured at timepoints pre-dose and 0; 5; 10; 15; 20; 40; 50; 60; 70; 90 120; 240; 360; 540; 720; 1,440; 2,160; 2,880 and 10,080 minutes post-dose).