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

• Status: Recruiting
• Trial end date: 2022-02-28
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TaiGen Biotechnology Co., Ltd.
• Collaborator: R&G Pharma Studies Co.,Ltd.

Criteria

Inclusion Criteria:

1. Willing and able to provide written informed consent.

2. Age ≥ 18 (or legal adult age) to < 65 years at the time of signing the informed consent.

3. Must have a positive result of Rapid influenza diagnostic test (RIDT) or Polymerase chain reaction (PCR).

4. The time interval between the onset of symptoms and the randomization is 48 hours or less.

5. Must be able to comply with all study procedures and assessments, including completion of the patient diary.

Exclusion Criteria:

1. Patients with severe influenza virus infection requiring inpatient treatment.

2. Patients with high risk factors may develop into severe cases.

3. Investigator suspects or confirms that patients with bronchitis, pneumonia, pleural effusion or interstitial disease through chest imaging examination.

4. Acute respiratory infection, otitis media or sinusitis within 2 weeks prior to Screening.

5. Purulent sputum or purulent tonsillitis.

6. Positive nucleic acid test for COVID-19.

7. Suspects allergic to active ingredients or excipients.

8. Body weight < 40 kg.

9. Has received anti-influenza drug.

10. Has received any investigational agents or devices for any indication within 30 days prior to Screening.

11. Patients who, in the opinion of the Investigator, may not be qualified or suitable for the study.