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Study of VIS410 in Subjects With Uncomplicated Influenza A

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02989194
Recruitment Status : Completed
First Posted : December 12, 2016
Last Update Posted : December 15, 2017
Sponsor:
Collaborator:
Biomedical Advanced Research and Development Authority
Information provided by (Responsible Party):
Visterra, Inc.

Brief Summary:
This is a Phase 2a randomized, double-blind, placebo-controlled study designed to assess the safety and tolerability of VIS410 in subjects with uncomplicated influenza.

Condition or disease Intervention/treatment Phase
Influenza Drug: VIS410 low dose Drug: VIS410 high dose Drug: Placebo Phase 2

Detailed Description:
Subjects will be admitted to an infusion unit for drug administration and observation following infusion. The study is designed to compare an infusion of a single high or low IV dose of VIS410 against placebo. Subjects will be followed for 100 (±7 days).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2a Double-blind, Placebo-controlled Study to Assess the Safety and Tolerability of a Single Intravenous Dose of VIS410 in Subjects With Uncomplicated Influenza A Infection
Study Start Date : December 2016
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: VIS410 low dose
Single intravenous fixed low dose of VIS410
Drug: VIS410 low dose
Single intravenous fixed low dose of VIS410

Experimental: VIS410 high dose
Single intravenous fixed high dose of VIS410
Drug: VIS410 high dose
Single intravenous fixed high dose of VIS410

Placebo Comparator: Placebo
Single intravenous placebo infusion
Drug: Placebo
Single intravenous infusion of placebo




Primary Outcome Measures :
  1. The proportion of subjects with adverse events (AEs) and serious adverse events (SAEs) following administration of VIS410 [ Time Frame: 100 days ]
  2. The proportion of subjects with treatment-emergent AEs (TEAEs) including hypersensitivity reaction, anaphylactic reaction, and AEs of special interest (AESIs) following dosing [ Time Frame: 100 days ]

Secondary Outcome Measures :
  1. The incidence, severity, and duration of signs and symptoms of influenza-like illness as assessed by the Influenza Patient Reported Outcomes questionnaire after a single IV dose of VIS410 [ Time Frame: 14 days ]
  2. Percentage of participants requiring hospitalization for influenza-related complications [ Time Frame: 100 days ]
  3. Duration of hospitalization for influenza-related complications [ Time Frame: 100 days ]
  4. Percentage of participants with complications of influenza [ Time Frame: 100 days ]
  5. Percentage of participants with influenza A relapse/reinfection [ Time Frame: 100 days ]
  6. VIS410 peak plasma concentration (Cmax) in serum [ Time Frame: 100 days ]
  7. Time to peak plasma concentration in serum (Tmax) [ Time Frame: 100 days ]
  8. VIS410 plasma concentration versus time curve (AUC) in serum [ Time Frame: 100 days ]
  9. VIS410 terminal half-life in serum [ Time Frame: 100 days ]
  10. The difference between VIS410 and placebo treatment groups in viral AUC from nasopharyngeal swabs [ Time Frame: 7 days ]
  11. The difference between VIS410 and placebo treatment groups in peak viral load from nasopharyngeal swabs [ Time Frame: 7 days ]
  12. The difference between VIS410 and placebo treatment groups in time to resolution of viral load from nasopharyngeal swabs [ Time Frame: 7 days ]
  13. Titer of anti-VIS410 antibody positive samples [ Time Frame: 100 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects aged ≥18 years and ˂65 years
  • Women should fulfill one of the following criteria:

    1. Post-menopausal; either amenorrhea ≥12 months or follicle stimulating hormone >40 mIU/mL as documented in their medical history
    2. Surgically sterile; hysterectomy, bilateral oophorectomy, or tubal ligation
    3. Women of childbearing potential participating in heterosexual sexual relations must be willing to use adequate contraception from screening until 60 days post infusion
  • Non-vasectomized (or vasectomized less than 6 months prior to dosing) male subjects who have a female partner of childbearing potential must use an effective birth control method when having heterosexual intercourse, from screening until 60 days post infusion
  • Test positive for influenza A by Rapid Antigen Test performed with a commercially available test on an adequate nasopharyngeal specimen in accordance with the manufacturer's instructions
  • Presence of at least one respiratory symptom (cough, sore throat, or nasal symptoms) of moderate to severe intensity, or presence of at least one constitutional symptom (myalgia [aches and pains], headache, feverishness, or fatigue) of moderate to severe intensity
  • Onset of symptoms (time when the temperature was first measured as elevated [temperature of ≥100.4°F or ≥38°C], OR the time when the subject experienced at least one respiratory symptom or at least one constitutional symptom) no more than 72 hours before the start of infusion

Exclusion Criteria:

  • Use of NSAIDs or antihistamines within 6 hours of study drug dosing with the exception of those used as part of the pretreatment regimen
  • History of intolerance or allergic response to monoclonal antibodies and/or pretreatment medications (diphenhydramine, ibuprofen and acetylsalicylic acid)
  • Subject weight less than (<) 45 kg
  • Subjects with clinical history that would lead to increased risk of influenza complications including but not limited to clinically significant cardiac disease, moderate to severe asthma, or other moderate to severe chronic obstructive pulmonary disease, metabolic syndrome including moderate to severe diabetes or active tuberculosis
  • History of chronic GI disease, including bleeding, ulceration, Irritable Bowel Syndrome, systemic mastocytosis or chronic diarrhea
  • Women who are pregnant, breast-feeding, or considering becoming pregnant
  • Patients with hypoxemia requiring oxygen support
  • Clinical evidence of worsening of any chronic medical condition (temporally associated with the onset of symptoms of influenza) which, in the Investigator's opinion, indicates that such finding(s) could represent complications of influenza
  • Presence of immunocompromised status due to chronic illness, previous organ transplant, or use of immunosuppressive medical therapy including systemic steroids
  • Presence of known Acquired Immune Deficiency Syndrome-defining illness, chronic hepatitis B or hepatitis C
  • Receipt of any dose of antiviral therapy such as, but not limited to, rimantadine, amantadine, peramivir, zanamivir, laninamivir or oseltamivir in the 7 days prior to screening
  • Enrollment in any other investigational drug or device study, any disease or vaccine study within 30 days prior to Day 1 or within 5 half-lives of the investigational compound, whichever is longer
  • Subjects unable to take oral predose medication
  • Known or suspected alcohol or drug abuse, that is, abuse of a level that would compromise the safety or cooperation of the subject in the opinion of the Investigator
  • Subjects on chronic medications where the dose has not been stable for at least 3 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02989194


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Sponsors and Collaborators
Visterra, Inc.
Biomedical Advanced Research and Development Authority
Investigators
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Study Director: Clinical Development Visterra, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Visterra, Inc.
ClinicalTrials.gov Identifier: NCT02989194     History of Changes
Other Study ID Numbers: VIS410-202
First Posted: December 12, 2016    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: December 2017
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases