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Study to Investigate the Efficacy and Safety of Apomivir®

NCT01677689 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2025-05-14

No results posted yet for this study

Summary

Apomivir® is extracted from a proprietary spirulina strain, FEM-101, a kind of blue cyanobacterium with patented freeze-thaw lysis and extraction method. According to the preclinical studies, Apomivir® have been proven to have excellent broad-spectrum anti-viral ability, especially for seasonal influenza viruses (Influenza virus A and B) that may cause illness, paralysis and even death, especially in children and elderly people. This phase II study is designed to evaluate the efficacy and safety of Apomivir® (120 mg b.i.d.) in subjects with seasonal influenza.

Conditions

Interventions

DRUG

Apomivir®

Study Group: Apomivir® 1 capsule twice daily. All subjects will be treated for 5 days, and all drugs should be taken orally after meal.

DRUG

Placebo

Control Group: Placebo 1 capsule twice daily. All subjects will be treated for 5 days, and all drugs should be taken orally after meal.

Sponsors & Collaborators

  • Far East Bio-Tec Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Liang-Wen Hang, MD · China Medical University Hospital

  • YI-HSIANG CHEN · Far East Bio-Tec Co., Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-05-31
Completion
2027-12-31

Countries

  • Taiwan

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01677689 on ClinicalTrials.gov