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An Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of S-033188 after Administration of a Single Dose to Otherwise Healthy Pediatric Patients Aged 6 Months to < 12 Years with Influenza

An Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of S-033188 after Administration of a Single Dose to Otherwise Healthy Pediatric Patients Aged 6 Months to < 12 Years with Influenza

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080223362
Enrollment
Unknown
Registered
2016-11-02
Start date
2016-11-02
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza A and/or B virus infection

Interventions

investigational material(s) Generic name etc : S-033188 INN of investigational material : Therapeutic category code : 625 Anti-virus agents Dosage and Administration for Investigational material : Or

Sponsors

Shionogi & Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients confirmed with influenza virus infection and within 48 hours from onset. Age: 6 months old or more 11years old or less

Exclusion criteria

Exclusion criteria: - Patients with severe symptoms of influenza virus infection requiring inpatient treatment. - Patients with high risk factors. - Patients with concurrent infections requiring antimicrobial therapy. etc.

Design outcomes

Primary

MeasureTime frame
Safety, efficacy, pharmacokinetics—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026