This study consists of two parts: the first part is a single-dose escalating(SAD) and food effect (FE)study, and the second part is a multiple-dose (14-day) escalating(MAD) study. Both phases are designed as randomized, double-blind, dose-escalation, placebo-controlled clinical studies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
32
GS3-007a dry suspension for oral use. Each sachet contains 50 mg of GS3-007a. The dry suspension is reconstituted with water before administration. Dosing is based on body weight, as specified in the arm descriptions. The product should be stored protected from light, in a sealed container, at or below 25°C.
Placebo dry suspension matching GS3-007a in appearance, odor, and packaging. It contains all excipients except the active ingredient, with added bitter agent. It is reconstituted with water before administration. Dosing is based on body weight, as specified in the arm descriptions. Storage conditions are the same as for the active drug.
Yuehong Plaza, No. 88 Hongcao Road, Xuhui District, Shanghai
Shanghai, Shanghai Municipality, China
RECRUITINGNumber of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: up to 6 days (SAD+FE phase), up to 21 days (MAD)
Pharmacokinetics (PK) Indicators - Maximum Observed Concentration (Cmax)
Time frame: up to 6 days (SAD+FE phase)
Pharmacokinetics (PK) Indicators - Time to Reach Maximum Observed Concentration (Tmax)
Time frame: up to 6 days (SAD+FE phase)
Pharmacokinetics (PK) Indicators - Area Under the Concentration-Time Curve from Time Zero to Time t (AUC0-t)
Time frame: up to 6 days (SAD+FE phase)
Pharmacokinetics (PK) Indicators - Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC0-∞)
Time frame: up to 6 days (SAD+FE phase)
Pharmacokinetics (PK) Indicators - Time to Reach Maximum Observed Concentration at Steady State (Tss,max)
Time frame: up to 21 days (MAD)
Pharmacokinetics (PK) Indicators - Maximum Observed Concentration at Steady State (Css,max)
Time frame: up to 21 days (MAD)
Pharmacokinetics (PK) Indicators - Minimum Observed Concentration at Steady State (Css,min)
Time frame: up to 21 days (MAD)
Pharmacokinetics (PK) Indicators - Average Observed Concentration at Steady State (Css,av)
Time frame: up to 21 days (MAD)
Pharmacodynamics(PD) Indicators
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Time frame: up to 6 days (SAD+FE phase), up to 21 days (MAD)
PD Indicators
Time frame: The entire MAD research phase