Actively Recruiting
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
Led by Joincare Pharmaceutical Group Industry Co., Ltd · Updated on 2026-01-21
177
Participants Needed
1
Research Sites
22 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this phase III study is to learn if JKN2301 Dry Suspension works to treat uncomplicated influenza in Pediatric Participants aged 2 to 11 years.
CONDITIONS
Official 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
- Clinical presentation consistent with influenza confirmed by positive rapid test or PCR
- Presentation for treatment within early symptomatic phase of influenza illness
- Presence of fever and at least one respiratory symptom
- Ability to swallow oral suspension
- Parent/guardian and patient able to provide informed consent/assent as appropriate
You will not qualify if you...
- Signs of severe or complicated influenza requiring hospital care
- Concurrent bacterial infection needing systemic therapy
- Significant immunocompromised or severe/uncontrolled other health conditions
- History of hypersensitivity to any study drug components
- Use of prohibited medications including other anti-influenza antivirals recently
- Recent participation in another interventional clinical trial
- Any condition that could risk patient safety or study compliance as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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