A Randomized Study of ALG-055009 Drug to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses in Healthy Volunteers and Subjects with Hyperlipidemia
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
98
Single or multiple doses of ALG-055009
Single or multiple doses of Placebo
Biotrial
Rennes, France
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Time frame: Up to 14 days for Part 1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Time frame: Up to 28 days for Part 2
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Time frame: Up to 35 days for Part 3
Maximum Plasma Concentration [Cmax]
Pharmacokinetic parameters of ALG-055009 in plasma
Time frame: Predose (between -0.25 hours and 0 hours) up to 35 Days
Area under the concentration time curve [AUC]
Pharmacokinetic parameters of ALG-055009 in plasma
Time frame: Predose (between -0.25 hours and 0 hours) up to 35 Days
Time to maximum plasma concentration [Tmax]
Pharmacokinetic parameters of ALG-055009 in plasma
Time frame: Predose (between -0.25 hours and 0 hours) up to 35 Days
Half-life [t1/2]
Pharmacokinetic parameters of ALG-055009 in plasma
Time frame: Predose (between -0.25 hours and 0 hours) up to 35 Days
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Minimum Plasma Concentration [Cmin]
Pharmacokinetic parameters of ALG-055009 in plasma
Time frame: Predose (between -0.25 hours and 0 hours) up to 35 Days
Change in lipid / lipoprotein levels from baseline through Day 28 in Multiple Dose in Subjects with Mild Hyperlipidemia
Time frame: Screening, Day -1 to Day 28