A Study of SYH2085 Tablets Compared With Placebo in Chinese Adult Patients With Uncomplicated Influenza.

NCT07798193 | Not Yet Recruiting Phase 2

• 1 other identifier: SYH2085-002
• Study Type: interventional
• Target: 213
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multicenter, randomized, double-blind, placebo-controlled Phase II study to evaluate the efficacy and safety of SYH2085 tablets compared with placebo in Chinese adult participants with uncomplicated influenza. The study plans to enroll patients with typical systemic and respiratory influenza symptoms, with symptom onset ≤48 hours.

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

• Time to resolution of all influenza symptoms (hours)

  Time to resolution of all influenza symptoms (hours) is defined as the time from start of study treatment to resolution of all influenza symptoms. Resolution of all influenza symptoms. is defined as all 7 influenza symptoms (headache, fever/chills, muscle/joint aches, fatigue, cough, nasal congestion, sore throat) rated as 2 or 3 becoming 0 (absent) or 1 (mild), and all clinical symptoms rated as 0 or 1 remaining resolved; with duration of resolution at least 21.5 hours (approximately 24 hours minus 10%).

  Up to Day22

Secondary Outcomes (26)

• Time to influenza virus RNA negativity (hours)

  Up to Day22

• Time to influenza virus titer negativity (hours)

  Up to Day22

• Change from baseline in influenza virus RNA (log10 copies/mL) at each visit

  Up to Day22

• Change from baseline in influenza virus and virus titer (log10 TCID50/mL) at each visit

  Up to Day22

• Viral load AUC and virus titer AUC

  Up to Day22

Study Arms (3)

SYH2085 40 mg

EXPERIMENTAL

Eligible participants will receive one 40-mg SYH2085 tablet and one placebo tablet orally on Day 1.

Drug: SYH2085; Drug: Placebo

SYH2085 80 mg

EXPERIMENTAL

Eligible participants will receive two 40-mg SYH2085 tablets orally on Day 1.

Drug: SYH2085

Placebo

PLACEBO COMPARATOR

Eligible participants will receive two SYH2085 placebo tablets orally on Day 1.

Drug: Placebo

Interventions

SYH2085 DRUG

One or two 40-mg SYH2085 tablets taken orally

SYH2085 40 mg; SYH2085 80 mg

Placebo DRUG

One or two placebo tablets taken orally

Placebo; SYH2085 40 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years at time of signing ICF.
• At screening, meet all of the following:
• Positive influenza antigen test or influenza virus nucleic acid test (other rapid molecular diagnostic methods are acceptable).
• Axillary temperature ≥37.3°C at screening; if antipyretics have been taken, axillary temperature ≥37.3°C at least 4 hours after dosing;
• At least one systemic influenza symptom of moderate or greater severity: muscle/joint aches, fatigue, headache, fever/chills;
• At least one respiratory influenza symptom of moderate or greater severity: nasal congestion, sore throat, cough.
• Time from onset of first influenza symptom to randomization ≤48 hours.
• Female participants must meet:
• Not of childbearing potential (i.e., hysterectomy, bilateral oophorectomy, documented ovarian failure, or postmenopausal defined as \>50 years and amenorrhea ≥12 months), or
• Of childbearing potential, with negative pregnancy test at screening, and not pregnant, peripartum, or breastfeeding.
• Participants and their partners agree to complete abstinence or use effective contraception from screening until 1 month after study completion.
• Male participants agree not to donate sperm from screening until 1 month after study completion.
• Understand and voluntarily sign ICF, willing and able to comply with all study procedures, and able to complete the participant diary as required.

You may not qualify if:

• Influenza virus infection requiring hospitalization (any of the following):
• Significant exacerbation of underlying diseases, e.g., COPD, diabetes, chronic heart failure, chronic renal failure, cirrhosis, etc.
• Any of the following severe case criteria:
• Respiratory rate ≥30/min;
• Oxygen saturation ≤93% on room air at rest;
• PaO2/FiO2 ≤300; for high-altitude areas (\>1000 m), correction: PaO2/FiO2 × \[760/atmospheric pressure (mmHg)\] (1 mmHg=0.133 kPa);
• Progressive clinical deterioration with lung imaging showing \>50% lesion progression within 24-48 hours.
• Any critical case criteria:
• Respiratory failure requiring mechanical ventilation;
• Shock;
• Acute necrotizing encephalopathy;
• Other organ failure requiring ICU monitoring.
• High-risk groups for severe/critical cases (any of the following):
• Severe or poorly controlled underlying diseases, e.g., COPD, liver disease (ALT or AST ≥3×ULN, total bilirubin ≥1.5×ULN), chronic kidney disease (serum creatinine \>177 μmol/L or 2 mg/dL), severe hematological disorders, chronic congestive heart failure (NYHA class III-IV), neurological and neuromuscular diseases, metabolic diseases, etc.;
• Clinically significant corrected QT interval abnormality on ECG (QTc \>450 ms for males or \>470 ms for females, QTcF by Fridericia formula);

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

86-31169085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: multicenter, randomized, parallel-group, placebo-controlled study

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: September 1, 2026
• Study Start (Estimated): October 10, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 1, 2026

Record last verified: 2026-07