Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04736758 | A Clinical Study on the Safety and Efficacy of GP681 Tablets in the Treatment of Uncomplicated Acute Influenza | PHASE2 | COMPLETED | 216 | — | — | Jan 8, 2021 | Dec 18, 2021 | Jul 26, 2022 | 1 | China |
| NCT06643156 | Study to Assess the Tolerability, Safety and Efficacy of GP681 Powder for Oral Suspension | PHASE1 | COMPLETED | 44 | — | — | Sep 27, 2024 | Jan 18, 2025 | Mar 18, 2025 | 1 | China |
Defined as the time from the start of treatment until the patient's body temperature returns to normal and all 7 flu symptoms (cough, sore throat, headache, nasal congestion, fever or chills, muscle or joint pain, fatigue) have alleviated (scoring 0 or 1 point) .
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
| Arm | Type | Description |
|---|---|---|
| GP681 tablet 40mg | EXPERIMENTAL | Patients in the GP681 tablet 40mg group is treated with GP681 tablet 40mg orally once with 240mL water. |
| GP681 tablet 20mg | EXPERIMENTAL | Patients in the GP681 tablet 40mg group is treated with GP681 tablet 20mg orally once with 240mL water. |
| Placebo group | PLACEBO_COMPARATOR | Patients in the Placebo group is treated with GP681 Simulant orally once with 240mL water. |
| GP681 powder for oral suspension 10mg/20mg/40mg | EXPERIMENTAL | All patients will receive a single oral dose of GP681 dry suspension dissolved in approximately 10 mL of warm water. The mixture will be stirred thoroughly before administration, and then the cup will be rinsed twice with an additional 10-20 mL of warm water (about 40°C) to ensure the full dose is taken. The dosage of GP681 in patients 2-18 years of age is a single weight-based dose displayed in the following table. Dosage Patients 40mg Aged 5-18years(exclusive)，weight≥40kg 20mg Aged 5-18years(exclusive)，20kg≤weight\<40kg 40mg Aged 5-18years(exclusive)，20kg≤weight\<40kg 10mg Aged 2-5years(exclusive)，10kg≤weight\<20kg 20mg Aged 2-5years(exclusive)，10kg≤weight\<20kg |
| Name | Type | Description |
|---|---|---|
| GP681 tablet | DRUG | influenza subjects is randomized 1:1:1 into GP681 tablet 40mg group,GP681 tablet 20mg group and Placebo group,with 72 patients in each group.subjects is given with GP681 tablet or GP681 Simulant only once to treat influenza. |
| GP681 Simulant | DRUG | influenza subjects is randomized 1:1:1 into GP681 tablet 40mg group,GP681 tablet 20mg group and Placebo group,with 72 patients in each group.subjects is given with GP681 tablet or GP681 Simulant only once to treat influenza. |
| GP681 10mg/20mg/40mg | DRUG | 0.5/1/2×20mg power for oral suspension taken orally |
Inclusion Criteria: * Positive Influenza rapid antigen test; * Fever (axillary temperature ≥37.3℃) or the axillary temperature ≥37.3℃ after taking the medicine for more than 4 hours; * At least one systemic symptom and respiratory symptom related to a moderate or above influenza virus infection: ...