To Assess the Efficacy of GP681 Tablet Versus Placebo in Patients With Acute Uncomplicated Influenza Virus Infection
NCT05474755 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 591
Last updated 2023-11-14
Summary
This study will evaluate the efficacy, safety, and population pharmacokinetics of a single, oral dose of GP681 compared with placebo in patients aged 12 to 65 years with acute uncomplicated influenza virus infection
Conditions
Interventions
- DRUG
-
GP681 40mg
2X20mg tablets taken orally
- DRUG
-
Placebo tablets matching GP681 40mg
Sponsors & Collaborators
-
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
lead INDUSTRY
Principal Investigators
-
Bin Cao, phd · China-Japan Friendship Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 5 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-07-28
- Primary Completion
- 2023-04-25
- Completion
- 2023-10-31
Countries
- China
Study Locations
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