A phase 2 a study to assess the safety profile and the effect of VIS410 in healthy subjects after inoculation with influenza A virus (H1N1).
This is a phase 2a randomized, double-blind, placebo-controlled study to be conducted in healthy volunteers. The study is designed to compare an infusion of a single dose of VIS410 against placebo. Eligible volunteers will be admitted to the clinical center and will receive a single intranasal administration of influenza A (H1N1). One day (24h) after inoculation, subjects will receive a single administration of VIS410 or placebo. Subjects will be confined in the clinical center for 10 days after virus administration. Assessment of safety will be determined from vital sign measurements, physical examinations, hematology, chemistry and urinalysis laboratory testing, 12-lead electrocardiograms (ECGs), pulmonary function, use of concomitant medications, and review of adverse events (AEs) should they occur. During confinement in the clinical center a symptom score card of influenza symptoms will be completed three times a day; nasopharyngeal swabs will be obtained three times a day and assayed for the presence of influenza virus and VIS410 concentration; serum samples will be assayed for VIS410 and the presence of cytokines. Upon release from the clinical center subjects will return for follow-up visits on days 14, 28 and either 56 or 84.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
46
SGS Life Sciences
Antwerp, Belgium
To assess the effect of VIS410 on the area under the curve of viral shedding over time.
The viral AUC will be measured, qRT-PCR, and compared between treatment groups
Time frame: 56-84 days
To assess the safety profile of VIS410
The proportion of subjects with post-infusion adverse events will be compared between treatment groups.
Time frame: 56-84 days
Assess the effects of VIS410 on viral shedding
The peak viral load and time to cessation of shedding will be measured (qRT-PCR and TCID50)
Time frame: 10 days
Assess the pharmacokinetics of VIS410 in serum
The following PK parameters will be calculated: Cmax, tmax, AUC, t1/2, Vd, Cl
Time frame: 56-84 days
Assess the immunogenicity of VIS410
The development of anti-drug antibodies will be measured
Time frame: 56-84 days
Assess the effect of VIS410 on clinical symptoms
The duration of symptoms will be compared between treatment groups
Time frame: 10 days
Assess antibody to challenge strain
The HAI antibody titer will be measured
Time frame: 28 days
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