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
Recruiting
Phase 3
Interventional Study
Respiratory Viral Infection
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 2 – 11
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 177 (estimated)
- Sponsor
- Joincare Pharmaceutical Group Industry Co., Ltd · Industry
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About This Trial
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Pediatric patients within the specified age range.
* Clinical presentation consistent with influenza, confirmed by a positive local rapid test or central laboratory PCR test.
* Presentation for treatment within the early symptomatic phase of influenza illness.
* Presence of fe…
Contacts