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.
This is a single-center, randomized, double-blind, placebo-controlled, single-dose administration, and dose escalation phase I clinical study in adult participants aged from 18 to 45 years old (including threshold) with healthy male and female subjects. The study includs a single dose ascending study (SAD) and a food effect (FE) study. The single ascending dose (SAD) study will be conducted by increasing the dosage from low dosage level to high. Approximately 40 participants will be randomized 3:1 to PG-033 or placebo in 5 dose groups. The food effect study adopts a single-center, randomized, open-label, single-dose, two-period and two-sequence crossover clinical trial design. 12 participants will be randomly divided into group A and group B, with 6 participants in each group. In the first period, the 6 subjects in Group A will take PG-033 on an empty stomach, while the 6 subjects in Group B will take PG-033 after having a high-fat meal. In the second period, the two groups will cross over in taking the drug. That is, the subjects in Group A will take PG-033 after having a high-fat meal, and the subjects in Group B will take PG-033 on an empty stomach. The washout period between the two dosing periods is 7 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
52
Oral tablets (2mg, 10mg)
Oral tablets (2 mg, 10 mg) (matching corresponding study medication)
Beijing Shijitan Hospital , Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGSafety and tolerability of PG-033 tablets
Incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs)
Time frame: Single Ascending Dose study: 7 days;Food Effect study: 14 days
Pharmacokinetics parameter: Cmax
Maximum Observed Plasma concentration (Cmax)
Time frame: up to 3 days
Pharmacokinetics Parameter:Tmax
Time at which the maximum plasma concentration (Cmax) occurs
Time frame: up to 3 days
Pharmacokinetics parameter: AUC0-t
Area under the plasma concentration-time curve from dosing (time zero) to the time of the last measured concentration
Time frame: up to 3 days
Pharmacokinetics parameter: AUC0-∞
Area Under the Plasma Concentration Versus Time Curve from Zero Extrapolated to Infinity (AUC0-∞)
Time frame: up to 3 days
Pharmacokinetics parameter: t1/2
Terminal Elimination Half-Life (t1/2)
Time frame: up to 3 days
Pharmacokinetics parameter: Vd/F
Volume of Distribution (Vd/F)
Time frame: up to 3 days
Pharmacokinetics parameter: CL/F
Total Body Clearance
Time frame: up to 3 days
Pharmacokinetics parameter: λZ
Elimination rate constant (λz)
Time frame: up to 3 days
Pharmacokinetics parameter: MRT
Mean retention time (MRT)
Time frame: up to 3 days
Corrected QT interval
Change in QT interval corrected for heart rate (QTc) interval from baseline
Time frame: up to 24 hours post-dose
Xiaohua Hao Beijing Shijitan Hospital Affiliated to Capital Medical Univer
CONTACT
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