About this trial
The goal of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) profiles of single ascending oral doses(SAD) of PG-033 by directly comparing it with placebo. Meanwhile, the impact of a high-fat meal on the pharmacokinetics of PG-033 will also be evaluated. The research will also explore the potential metabolites and metabolic pathways of PG-033 within the human body,as well as investigate the effect of PG-033 on the QTc interval.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
1. Read, understood, and signed an ICF before any investigational procedure(s) are performed.
Disqualifiers
1. Participants with abnormal electrocardiogram results during screening (e.g., QT/QTcF > 440 ms, PR interval > 200 ms, QRS complex duration > 100 ms, clinically significant abnormalities of the P wave, clinically significant changes in the ST-T wave, etc.).
Trial design
Parallel
Treatments tested in this trial
PG-033
DrugOral tablets (2mg, 10mg)
PG-033 placebo comparator
DrugOral tablets (2 mg, 10 mg) (matching corresponding study medication)
Treatment groups
Trial outcomes
Primary outcomes
Safety and tolerability of PG-033 tablets
Incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs)
Secondary outcomes
Pharmacokinetics parameter: Cmax
Maximum Observed Plasma concentration (Cmax)
Pharmacokinetics Parameter:Tmax
Time at which the maximum plasma concentration (Cmax) occurs
Pharmacokinetics parameter: AUC0-t
Area under the plasma concentration-time curve from dosing (time zero) to the time of the last measured concentration
Pharmacokinetics parameter: AUC0-∞
Area Under the Plasma Concentration Versus Time Curve from Zero Extrapolated to Infinity (AUC0-∞)
Sponsors and contacts
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