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OpenTrials
Completed

NCT Number: NCT04729764

Evaluation the Safety and Tolerance of GP681 Tablets in Healthy Subjects

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shanghai Xuhui Central Hospital

Shanghai, Shanghai Municipality, 200031, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

GP681 tablet

Drug

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.

Primary outcomes

  1. Pharmacokinetic parameter

    Time frame: 12 days

    Peak concentration (Cmax)

  2. ncidence of adverse events as a measure of safety and tolerability

    Time frame: 12 days

    Observed side effects and alteration in laboratory values.

  3. area under the drug-time curve

    Time frame: 12 days

    area under the drug-time curve (AUC0-t, AUC0-∞)

Sponsors and collaborators

Lead sponsor

Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Industry

Registry information

Official study title

A Single-center, Randomized, Double-blind, Placebo-controlled and Single-center, Randomized, Open, Double-crossed Food Impact Trial to Evaluate the Safety, Tolerability, Pharmacokineticof GP681 Tablets in Healthy Subjects

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 28, 2021
Registry last updated
Jan 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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