Influenza
Conditions
Brief summary
Influenza (influenza for short) is an acute respiratory infectious disease caused by influenza virus. The symptoms of the disease range from mild, moderate to severe, and severe cases require hospitalization and may die. According to estimates by the US Centers for Disease Control and Prevention in 2018, influenza causes approximately 290,000 to 640,000 deaths worldwide each year. Therefore, the prevention and treatment of influenza has become a serious public health problem.
Detailed description
The GP681 in this test is a prodrug of a polymerase acidic protein (PA, Polymerase Acidic protein) inhibitor. Its metabolite GP1707D07 can selectively inhibit the cap-dependent endonuclease of influenza virus and prevent influenza virus replication. Mechanism of action against influenza virus. The results of previous non-clinical studies show that GP681 can effectively inhibit influenza virus replication, has good safety, and has antiviral activity 1,000 times that of oseltamivir phosphate. It also has good antiviral activity against oseltamivir resistant strains. And it is expected to have a longer half-life than oseltamivir phosphate. Therefore, it is expected that a new type of PA inhibitor can be developed to provide patients with influenza with a new mechanism of action, better efficacy, and higher compliance.
Interventions
DRUGGP681 Tablet
Designed as 5 dose groups (20mg, 40mg, 60mg, 80mg, 120mg), the starting dose group (20mg) 8 subjects (including 2 placebo), each other 10 subjects (including Placebo (2 cases), male and female.
Sponsors
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
This trial uses a double-blind technique, that is, neither the investigator nor the subject knows what kind of drug they are taking. The sponsor or its designated unit shall provide the trial drug and placebo to ensure that the placebo's shape, color, smell, taste, and weight are consistent with the trial drug, and the drug randomization and supply management system (RTSM) is used for drug randomization
Intervention model description
According to the initial dose and maximum dose interval, it is designed as 5 dose groups (20mg, 40mg, 60mg, 80mg, 120mg), the initial dose group (20mg) has 8 subjects (including 2 placebo), and each of the others 10 subjects in the dose group (including 2 placebo), male and female.
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
\- 18-45 years old, male or female (the food impact test is limited to males); male ≥50 kg, female ≥45kg,BMI19-26; Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent form, and be able to complete the entire trial process according to the trial requirements.
Exclusion criteria
\- history of allergies, allergic diseases or allergies to drugs in research; medical history of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic disorders, etc. or other diseases that are not suitable for participating in clinical trials (such as mental illness history, etc.); donated blood or blood loss ≥ 400 mL within 3 months before enrollment;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic parameter | 12 days | Peak concentration (Cmax) |
| ncidence of adverse events as a measure of safety and tolerability | 12 days | Observed side effects and alteration in laboratory values. |
| area under the drug-time curve | 12 days | area under the drug-time curve (AUC0-t, AUC0-∞) |
Countries
China
Outcome results
None listed