NCT06342921

ADC189 Tablets on Influenza A Virus Infection/Influenza B Virus Infection

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II/III Study of the Safety and Efficacy of ADC189 Tablets in the Treatment of Influenza A Virus Infection/Influenza B Virus Infection in Adolescents and Adults

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 749 (actual)
• Sponsor: Jiaxing AnDiCon Biotech Co.,Ltd · Industry
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this Phase II/III study is to investigate the safty and efficacy of ADC189 tablets in adolescents and adults with influenza A virus infection/influenza B virus infection. The main aim to answer: * Phase II study is to evaluate the efficacy of ADC189 tablets in the treatment of adult influenza subjects and determine the optimal therapeutic dose by analyzing the time of virus titer turning to negative. All the results will be used to design the Phase III study. * Phase III study is to evaluate the efficacy of ADC189 tablets by analyzing the duration of remission of all influenza symptoms in adolescents and adults subjects with influenza. Participants will be taken ADC189 teblets/Placebo once, and be observed by 22 days. Phase II study has 3 groups: 15 mg ADC189; 45 mg ADC189; and Placebo; Phase III study has 2 groups: 45 mg ADC189; and Placebo.

Conditions

• Safety Issues
• Effect of Drug

Interventions

Type	Name	Description
DRUG	15 mg ADC189	Use only once during the whole study.
DRUG	45 mg ADC189	Use only once during the whole study.
DRUG	Placebo	Use only once during the whole study.

Timeline

• Start date: 2022-12-07
• Primary completion: 2023-10-08
• Completion: 2024-01-22
• First posted: 2024-04-02
• Last updated: 2025-01-21

Locations

1 site across 1 country: China