Actively Recruiting
A Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled Phase III Study Evaluating Safety, Pharmacokinetics, and Efficacy of JKN2301 Dry Suspension in Pediatric Patients Aged 2 to Under 12 Years With Influenza
Led by Joincare Pharmaceutical Group Industry Co., Ltd · Updated on 2026-01-21
177
Participants Needed
1
Research Sites
10 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, pharmacokinetics, and effectiveness of JKN2301 Dry Suspension in treating uncomplicated influenza in children aged 2 to 11 years. This phase III study compares JKN2301 with Oseltamivir and aims to understand how well JKN2301 works for influenza in pediatric patients. The study is sponsored by Joincare Pharmaceutical Group Industry Co., Ltd and focuses on early treatment during the symptomatic phase of influenza. Participants are randomly assigned to receive either a single oral dose of JKN2301 Dry Suspension with a placebo matching Oseltamivir or an oral suspension of Oseltamivir twice daily for 5 days with a placebo matching JKN2301. The dosing is based on weight tiers for both treatments. The study is double-blind and double-dummy, ensuring participants and researchers do not know which treatment is given. Treatment effects and safety are monitored closely throughout the study. During the study, participants will be monitored from baseline through Day 15 for adverse events, physical exams, vital signs, lab tests, and ECGs. Researchers will measure influenza symptom relief, fever duration, viral shedding, viral load changes, and complications up to Day 15. Plasma levels of JKN2301 and metabolites will be assessed up to Day 6. The total participation includes treatment and follow-up visits to assess safety and treatment outcomes.
CONDITIONS
Brief Title
Phase III Clinical Study Evaluating the Safety, Pharmacokinetics, and Efficacy of JKN2301 Dry Suspension in Pediatric Patients Aged 2 to Under 12 Years With Influenza
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pediatric patients aged 2 to under 12 years
- Confirmed influenza by positive rapid test or PCR
- Presenting for treatment early in symptomatic phase
- Fever and at least one respiratory symptom present
- Able to swallow oral suspension
- Parent/guardian and patient able to provide informed consent/assent
You will not qualify if you...
- Signs of severe or complicated influenza needing hospital care
- Concurrent bacterial infection requiring systemic therapy
- Significant immunocompromised or severe/uncontrolled comorbid conditions
- History of hypersensitivity to study drug components
- Use of prohibited medications including other antivirals before enrollment
- Recent participation in another interventional clinical trial
- Any condition risking patient safety or protocol compliance as judged by investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 days
Participants receive a single oral dose of JKN2301 Dry Suspension or placebo, and either Oseltamivir or Oseltamivir placebo twice daily for 5 days according to weight-based dosing.
Daily visits or contacts during treatment for dosing and monitoring
Duration - Up to 10 days after treatment
Participants are monitored for safety, symptom alleviation, and viral shedding up to Day 15 after treatment initiation.
Approximately 2 follow-up visits or contacts
Trial Site Locations
Total: 1 location
1
First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
Y
Ying Yang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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