NCT04706468

To Evaluate the Efficacy and Safety of TG-1000 Compared With Placebo in Adult Patients With Acute Uncomplicated Influenza Virus Infection

A Phase 2, Multicenter, Randomized, Double-blind, Dose-ranging Study to Evaluate the Efficacy and Safety of TG-1000 Compared With Placebo in Adult Patients With Acute Uncomplicated Influenza Virus Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: TaiGen Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the antiviral effect of TG-1000 compared with placebo in adult patients with acute uncomplicated influenza virus infection.

Detailed description

This study is a multicenter, randomized, double-blind, dose-ranging study to evaluate the efficacy and safety of different doses of TG-1000 compared with placebo in adult patients with acute uncomplicated influenza virus infection. Approximately 200 patients will be randomly assigned to 1 of 4 treatments groups in a ratio of 1:1:1:1 to receive study treatment orally: "40 mg TG-1000", "80 mg TG-1000", "40mg+40mg TG-1000" or "placebo".

Conditions

• Influenza Virus Infection

Interventions

Type	Name	Description
DRUG	TG-1000	Capsules taken orally

Timeline

• Start date: 2020-12-15
• Primary completion: 2022-02-15
• Completion: 2022-02-15
• First posted: 2021-01-12
• Last updated: 2022-03-09

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study