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NOT YET RECRUITING
NCT07893847
PHASE2/PHASE3

Evaluation of the Efficacy and Safety of 102D-6 in the Treatment of Acute Uncomplicated Influenza

Sponsor: Capital Medical University

View on ClinicalTrials.gov

Summary

The goal of this Phase II/III study is to investigate the safty and efficacy of 102D-6 in adolescents and adults with influenza. The main aim to answer: 1. Phase II study is to evaluate the efficacy of 102D-6 in the treatment of adult influenza subjects and determine the optimal therapeutic dose by analyzing the time of virus titer turning to negative. The results will be used to design the Phase III study. 2. Phase III study is to evaluate the efficacy of 102D-6 by analyzing the duration of remission of all influenza symptoms in adolescents and adults subjects with influenza. Participants will be taken 102D-6/Placebo once, and be observed by 15 days.

Official title: A Randomized, Double-blind, Multicenter, Phase II/III Study to Evaluate the Efficacy and Safety of 102D-6 in the Treatment of Uncomplicated Influenza.

Key Details

Gender

All

Age Range

12 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

570

Start Date

2026-10-21

Completion Date

2027-03-30

Last Updated

2026-10-26

Healthy Volunteers

No

Interventions

DRUG

20 mg 102D-6 dry suspension

Use only once during the whole study.

DRUG

40 mg 102D-6 dry suspension

Use only once during the whole study.

DRUG

Placebo

Use only once during the whole study.

Locations (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China