The goal of this clinical trial is to learn about the safety, tolerability and pharmacokinetics of LIB-01 in healthy male participants. The main questions it aims to answer are: * How safe and tolerable is LIB-01 when given once or repeatedly at different dose levels. * What are the pharmacokinetic characteristics of LIB-01 Participants will receive LIB-01 and be followed up for safety and pharmacokinetics by: * Adverse events * ECG * Blood sampling for laboratory parameters and pharmacokinetic analysis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
64
Clinical Trial Consultants
Uppsala, Sweden
To evaluate the incidence of treatment-emergent adverse events as assessed by CTCAE in healthy male participants, following a single oral dose of LIB-01.
Frequency, seriousness and intensity of adverse events. Adverse events will be graded from 1-5 by the Common Terminology Criteria for Adverse Events (CTCAE): Grade 1, Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2, Moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Grade 3, Severe or medically significant but not immediately life-threatening; hospitalisation or prolongation of hospitalisation indicated; disabling; limiting self- care ADL. Grade 4, Life-threatening consequences: urgent intervention indicated. Grade 5, Death related to AE.
Time frame: 14 days
To evaluate changes in vital signs in healthy male participants, following a single oral dose of LIB-01.
Clinically significant changes in vital signs (blood pressure, pulse, respiratory rate, body temperature).
Time frame: 14 days
To evaluate changes in ECG in healthy male participants, following a single oral dose of LIB-01.
Clinically significant changes in ECG parameters (resting heart rate \[HR\] and PQ/PR, QRS, QT and QTcF intervals).
Time frame: 14 days
To evaluate the incidence of treatment-emergent adverse events as assessed by CTCAE in healthy male participants, following multiple oral dosing of LIB-01.
Frequency, seriousness and intensity of adverse events. Adverse events will be graded from 1-5 by the Common Terminology Criteria for Adverse Events (CTCAE): Grade 1, Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2, Moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living (ADL). Grade 3, Severe or medically significant but not immediately life-threatening; hospitalisation or prolongation of hospitalisation indicated; disabling; limiting self- care ADL. Grade 4, Life-threatening consequences: urgent intervention indicated. Grade 5, Death related to AE. Clinically significant changes in vital signs, ECG and safety laboratory measurements.
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Time frame: 28 days
To evaluate changes in vital signs in healthy male participants, following a multiple oral dosing of LIB-01.
Clinically significant changes in vital signs (blood pressure, pulse, respiratory rate, body temperature).
Time frame: 28 days
To evaluate changes in ECG in healthy male participants, following multiple oral dosing of LIB-01.
Clinically significant changes in ECG parameters (resting heart rate \[HR\] and PQ/PR, QRS, QT and QTcF intervals).
Time frame: 28 days
To characterise the maximum plasma concentration of LIB-01, following a single oral dose.
Maximum Plasma Concentration \[Cmax\]
Time frame: 3 days
To characterise the plasma concentration half life of LIB-01, following a single oral dose.
Plasma Concentration Half Life \[T1/2\]
Time frame: 3 days
To characterise the plasma concentration area under curve of LIB-01, following a single oral dose.
Plasma Concentration Area Under Curve \[AUC\]
Time frame: 3 days
To characterise the maximum plasma concentration of LIB-01 following multiple oral dosing.
Maximum Plasma Concentration \[Cmax\]
Time frame: 4 days
To characterise the plasma concentration half life of LIB-01 following multiple oral dosing.
Plasma Concentration Half Life \[T1/2\]
Time frame: 4 days
To characterise the plasma concentration half life of LIB-01 following multiple oral dosing.
Plasma Concentration Area Under Curve \[AUC\]
Time frame: 4 days