Evaluation the Safety and Tolerance of GP681 Tablets in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-27

Study Completion Date

2020-12-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of GP681 Tablets Compared With Placebo in Patients With Influenza at High Risk of Influenza Complications

NCT06573008

Influenza, Human

RECRUITING PHASE3

Study to Assess the Efficacy and Safety of GP681 Versus Placebo for Postexposure Prophylaxis Against Influenza

NCT06574503

Influenza

RECRUITING PHASE3

To Assess the Efficacy of GP681 Tablet Versus Placebo in Patients With Acute Uncomplicated Influenza Virus Infection

NCT05474755

Influenza

COMPLETED PHASE3

A Clinical Study on the Safety and Efficacy of GP681 Tablets in the Treatment of Uncomplicated Acute Influenza

NCT04736758

Influenza

COMPLETED PHASE2

Study to Assess the Tolerability, Safety and Efficacy of GP681 Powder for Oral Suspension

NCT06643156

Influenza

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Influenza

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

GP681 Tablet 20mg

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).

Group Type EXPERIMENTAL