Evaluation the Safety and Tolerance of GP681 Tablets in Healthy Subjects

NCT04729764 | Completed Phase 1

• 1 other identifier: GP681101/CRC-C1933
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetic parameter

  Peak concentration (Cmax)

  12 days

• ncidence of adverse events as a measure of safety and tolerability

  Observed side effects and alteration in laboratory values.

  12 days

• area under the drug-time curve

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

  12 days

Study Arms (5)

GP681 Tablet 20mg

EXPERIMENTAL

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).

Drug: GP681 Tablet

GP681 Tablet 40mg

EXPERIMENTAL

10 subjects in 40mg group (including 2 placebo)

Drug: GP681 Tablet

GP681 Tablet 60mg

EXPERIMENTAL

10 subjects in 60mg group (including 2 placebo)

Drug: GP681 Tablet

GP681 Tablet 80mg

EXPERIMENTAL

10 subjects in 80mg group (including 2 placebo)

Drug: GP681 Tablet

GP681 Tablet 120mg

EXPERIMENTAL

10 subjects in 120mg group (including 2 placebo)

Drug: GP681 Tablet

Interventions

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.

GP681 Tablet 120mg; GP681 Tablet 20mg; GP681 Tablet 40mg; GP681 Tablet 60mg; GP681 Tablet 80mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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;

Sponsors & Collaborators

• Jiangxi Qingfeng Pharmaceutical Co. Ltd.: lead

Study Sites (1)

Shanghai Xuhui Central Hospital

Shanghai, Shanghai Municipality, 200031, China

Location

Related Publications (1)

• Wu Q, Lv L, Yan S, Wang Y, Chen Q, Xu W, Liu Y, Wang W, Jia J, Yu C, Chen J, Liu Y. A first-in-human phase I study to evaluate the safety, tolerability, and pharmacokinetics of a novel anti-influenza agent suraxavir marboxil in healthy Chinese subjects. Antimicrob Agents Chemother. 2025 Nov 5;69(11):e0068525. doi: 10.1128/aac.00685-25. Epub 2025 Sep 30.

  PMID: 41025645 DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• liu yanmei

  Shanghai Xuhui Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: January 28, 2021
• Study Start: August 27, 2020
• Primary Completion: December 15, 2020
• Study Completion: December 15, 2020
• Last Updated: January 28, 2021

Record last verified: 2020-08

Locations

CN (1)