A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Safety and Efficacy of Onradivir Tablets in Participants Aged 12 to 17 Years With Uncomplicated Influenza A.

Sponsor
Ruijin Hospital
Study ID
NCT07229547
Phase
PHASE3
Status
Recruiting
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Conditions

  • Influenza

Eligibility Criteria

Sex
ALL
Age
12 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    A placebo that resembles Onradivir tablet in appearance, weight, and odor. The external packaging of Onradivir tablet and the placebo is identical. Take placebo once daily, 3 tablets per dose, for a total of 5 days (5 doses).
  • Onradivir tablet — DRUG
    Take Onradivir Tablets once daily, 600 mg (3 tablets) per dose, for a total of 5 days (5 doses).

Study Details

This randomized, double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of Onradivir Tablets in participants aged 12 to 17 years with influenza A virus infection. The trial plans to enroll approximately 150 adolescent participants (12-17 years) with uncomplicated influenza A, confirmed by rapid antigen/nucleic acid testing and within 48 hours of symptom onset. Eligible participants who meet the inclusion criteria and do not meet any exclusion criteria will be randomized in a 2:1 ratio to receive either Onradivir Tablets or placebo once daily for 5 consecutive days. The study consists of a screening period, a treatment period, and a safety follow-up period. Each participant will be followed up until Day 14 after the first dose. Nasopharyngeal swabs will be collected at screening, Day 2, Day 4, Day 5, and Day 10 for virological testing, including: Viral load measurement by reverse transcription quantitative polymerase chain reaction (RT-qPCR) Viral titer determination by culture assay (50% tissue culture infectious dose, TCID₅₀) Throughout the treatment and safety follow-up periods, participants will record body temperature, influenza symptom scores, and daily activity scores using a diary card. Clinical laboratory tests will be performed at screening, Day 5, and Day 15. Physical examinations and vital signs measurements will be conducted at each follow-up visit. Adverse events and concomitant medications will be documented throughout the study.

Key Dates

First listed
Nov 17, 2025
Start date
Nov 14, 2025
Status verified
Sep 2025
Primary completion
Dec 1, 2026
Completion
Dec 1, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo Group
    Placebo Group: Take the Onradivir Tablets matching placebo once daily, 3 tablets per dose, for a total of 5 days (5 doses).
  • Experimental: Onradivir Tablet Group
    Onradivir Tablets Group: Take Onradivir Tablets once daily, 600 mg (3 tablets) per dose, for a total of 5 days (5 doses).

Primary Outcome Measure

Time to alleviation of influenza symptoms [ Time Frame: Up to Day 15 ]

Central Contacts

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