Evaluation the Safety and Tolerance of GP681 Tablets in Healthy Subjects

Qingfeng Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Influenza

Treatments: Drug: GP681 Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT04729764

GP681101/CRC-C1933

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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56 participants in 5 patient groups

GP681 Tablet 20mg

Experimental group

Description:

Two sentinel subjects were first enrolled in the trial (test drug: placebo=1:1). After the two sentinel subjects completed the 72h safety follow-up after the administration, it was judged that if there was no dose-limiting toxicity , Then start the trial of the remaining 6 subjects in the dose group (experimental drug: placebo = 5:1).

Treatment:

Drug: GP681 Tablet

GP681 Tablet 40mg

Experimental group

Description:

10 subjects in 40mg group (including 2 placebo)

Treatment:

Drug: GP681 Tablet

GP681 Tablet 60mg

Experimental group

Description:

10 subjects in 60mg group (including 2 placebo)

Treatment:

Drug: GP681 Tablet

GP681 Tablet 80mg

Experimental group

Description:

10 subjects in 80mg group (including 2 placebo)

Treatment:

Drug: GP681 Tablet

GP681 Tablet 120mg

Experimental group

Description:

10 subjects in 120mg group (including 2 placebo)

Treatment:

Drug: GP681 Tablet