| Outcome Measures: |
To assess safety and tolerability of BioE-1115 following escalating single and multiple doses of BioE-1115 in healthy volunteers.[The safety and tolerability will be evaluated by targeted physical examination including Adverse Events (AEs) reporting, Weight, Vital signs (blood pressure, heart rate, body temperature, respiration rate), 12-lead electrocardiogram (ECG) monitoring, Ambulatory arrhythmia monitoring (telemetry), Blood and urine sampling for haematology, clinical chemistry including Creatinine Phosphokinase (CPK) and cardiac troponins and coagulation<br>]To determine pharmacokinetics (PK), including the effects on PK in fed vs. fasting states, of single ascending doses (SAD) of BioE-1115.
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<br>PK parameters- Area under the plasma concentration time curve (AUC), maximum concentration (Cmax), time to maximum concentration (Tmax). The PK concentrations by nominal time profile data will be presented graphically on linear and log-linear scales. Individual subject profiles (spaghetti or overlay plots) will be presented for each dosing group. The mean and median concentrations over time will also be presented. PK concentrations will be assessed using both plasma and urinalysis.[Part A (SAD):
<br>PK analysis will be collected on Day 1 at pre-dose (within 5 minutes prior to IMP administration) and post-dose at 20 minutes, 40 minutes, 60 minutes, 90 minutes, 120 minutes, 180 minutes, 4 hours, 6 hours, 9 hours, 12 hours and 18 hours; on Day 2 (24 hours post dosing on Day 1) and on Day 3 (48 hours post dosing on Day 1)
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<br>];To assess the PK effects of BioE-1115 assessed as fructose-stimulated de-novo lipogenesis (FS-DNL) and resting metabolic rate (RMR) of multiple ascending doses (MAD) of BioE-1115.[Part B (MAD):
<br>FS-DNL will be measured using sodium [1-13C1] acetate at approximately 1 week prior to the initiation of dosing and at the end of dosing. Subjects will undergo measurement of RMR along with the FS-DNL measurement.
<br>Blood samples for PK analysis will be collected on Day 1 at pre-dose (within 5 minutes prior to IMP administration) and post-dose at 20 minutes, 40 minutes, 60 minutes, 90 minutes, 120 minutes, 180 minutes, 4 hours, 6 hours, 9 hours, 12 hours and 18 hours; on Day 2 (24 hours post Day 1 dosing time) and on Day 3 (48 hours post Day 2 dosing time)
<br>On Day 5, blood samples for PK analysis will be collected at pre-dose (within 5 minutes prior to IMP administration) only
<br>Blood samples for PK analysis will again be collected on Day 7 at pre-dose (within 5 minutes prior to IMP administration) and post-dose at 20 minutes, 40 minutes, 60 minutes, 90 minutes, 120 minutes, 180 minutes, 4 hours, 6 hours, 9 hours, 12 hours and 18 hours; on Day 8 (24 hours post Day 7 dosing time) and on Day 9 (48 hours post Day 7 dosing time).
<br>Urine sampling for PK will be collected at 0 to 2 hours, 2 to 4 hours, 4 to 9 hours, 9 to 24 hours post Day 1 and Day 7 dosing time. Urine samples will also be collected at 24-36 and 36-48 hr time points post the last dose on Day 7. ];To assess the Pharmacodynamic (PD) effects of
<br>BioE-1115 assessed as fructose-stimulated de-novo lipogenesis (FS-DNL) and resting metabolic rate (RMR) of multiple ascending doses (MAD) of BioE-1115.[FS-DNL will be measured using sodium [1-13C1] acetate at approximately 1 week prior to the initiation of dosing and at the end of dosing. Subjects will undergo measurement of RMR along with the FS-DNL measurement. RMR will be measured by indirect calorimetry.
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