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

Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Study ID
NCT07798193
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Influenza

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SYH2085 — DRUG
    One or two 40-mg SYH2085 tablets taken orally
  • Placebo — DRUG
    One or two placebo tablets taken orally

Study Details

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.

Key Dates

First listed
Sep 1, 2026
Start date
Oct 10, 2026
Status verified
Jul 2026
Primary completion
Apr 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
213 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SYH2085 40 mg
    Eligible participants will receive one 40-mg SYH2085 tablet and one placebo tablet orally on Day 1.
  • Experimental: SYH2085 80 mg
    Eligible participants will receive two 40-mg SYH2085 tablets orally on Day 1.
  • Placebo Comparator: Placebo
    Eligible participants will receive two SYH2085 placebo tablets orally on Day 1.

Primary Outcome Measure

Time to resolution of all influenza symptoms (hours) [ Time Frame: Up to Day22 ]

Central Contacts

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