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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GS3-007a- dose level 1 (SAD/FE) | Experimental |
| |
| GS3-007a- dose level 2 (SAD/FE) | Experimental |
| |
| Placebo (SAD/FE) | Placebo Comparator |
| |
| GS3-007a- dose level 1 (MAD) | Experimental |
| |
| GS3-007a- dose level 2 (MAD) | Experimental |
| |
| Placebo (MAD) | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GS3-007a for Suspension | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | up to 6 days (SAD+FE phase), up to 21 days (MAD) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) Indicators - Maximum Observed Concentration (Cmax) | up to 6 days (SAD+FE phase) | |
| Pharmacokinetics (PK) Indicators - Time to Reach Maximum Observed Concentration (Tmax) | up to 6 days (SAD+FE phase) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hong Xu | Contact | +86 15702440681 | xuhong01@genscigroup.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yuehong Plaza, No. 88 Hongcao Road, Xuhui District, Shanghai | Recruiting | Shanghai | Shanghai Municipality | 200233 | China |
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| ID | Term |
|---|---|
| D013535 | Suspensions |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Placebo GS3-007a for Suspension | Drug | 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. |
|
| Pharmacokinetics (PK) Indicators - Area Under the Concentration-Time Curve from Time Zero to Time t (AUC0-t) | up to 6 days (SAD+FE phase) |
| Pharmacokinetics (PK) Indicators - Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC0-∞) | up to 6 days (SAD+FE phase) |
| Pharmacokinetics (PK) Indicators - Time to Reach Maximum Observed Concentration at Steady State (Tss,max) | up to 21 days (MAD) |
| Pharmacokinetics (PK) Indicators - Maximum Observed Concentration at Steady State (Css,max) | up to 21 days (MAD) |
| Pharmacokinetics (PK) Indicators - Minimum Observed Concentration at Steady State (Css,min) | up to 21 days (MAD) |
| Pharmacokinetics (PK) Indicators - Average Observed Concentration at Steady State (Css,av) | up to 21 days (MAD) |
| Pharmacodynamics(PD) Indicators | up to 6 days (SAD+FE phase), up to 21 days (MAD) |
| PD Indicators | The entire MAD research phase |