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

TaiGen Biotechnology

Status and phase: Completed; Phase 2

Conditions: Influenza Virus Infection

Treatments: Drug: TG-1000

Study type: Interventional

Funder types: Industry

Identifiers

NCT04706468

TG-1000-C-02

Details and patient eligibility

About

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

Full 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".

Enrollment: 202 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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202 participants in 4 patient groups, including a placebo group

40 mg TG-1000

Experimental group

Description:

Participants received 40 mg of TG-1000 and 40 mg of placebo orally on Day 1 and 40 mg of placebo on Day 3.

Treatment:

Drug: TG-1000

80 mg TG-1000

Experimental group

Description:

Participants received 80 mg of TG-1000 orally on Day 1 and 40 mg of placebo on Day 3.

Treatment:

Drug: TG-1000

40 mg TG-1000+40 mg TG-1000

Experimental group

Description:

Participants received 40 mg of TG-1000 and 40 mg of placebo orally on Day 1 and 40 mg of TG-1000 on Day 3.

Treatment:

Drug: TG-1000

Placebo

Placebo Comparator group

Description:

Participants received 80 mg of placebo orally on Day 1 and 40 mg of placebo on Day 3.

Treatment:

Drug: TG-1000