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

NCT06643156 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2025-03-18

No results posted yet for this study

Summary

This study aims to evaluate the tolerability, safety, pharmacokinetic characteristics and efficacy of a single oral dose of GP681 powder for oral suspension in pediatric and adolescent patients with uncomplicated influenza. The study will also explore the optimal dose for a confirmatory clinical trial. Eligible patients who have been confirmed influenza virus infection and have experienced influenza symptoms within 48 hours prior to enrollment, will receive single dose of GP681 powder for oral suspension. The primary outcome measures included the observation of adverse events during the study, the pharmacokinetic parameters, as well as the efficacy endpoints including time to alleviation of influenza symptoms, viral clearance rate, changes in viral load, etc.

Conditions

Interventions

DRUG

GP681 10mg/20mg/40mg

0.5/1/2×20mg power for oral suspension taken orally

Sponsors & Collaborators

  • Jiangxi Qingfeng Pharmaceutical Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-27
Primary Completion
2025-01-18
Completion
2025-01-18

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06643156 on ClinicalTrials.gov