Study to Investigate the Efficacy and Safety of Apomivir®

Sponsor
Far East Bio-Tec Co., Ltd
Study ID
NCT01677689
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Influenza

Eligibility Criteria

Sex
ALL
Age
20 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Sep 3, 2012
Start date
May 31, 2026
Status verified
May 2025
Primary completion
May 31, 2027
Completion
Dec 31, 2027

Study Design

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

Arms

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

Primary Outcome Measure

To evaluate the safety profile of Apomivir® treatment (120 mg b.i.d.). [ Time Frame: from day1 to day 29, the entire treatment period and follow-up period. ]

Central Contacts

Related Studies