Study of an Investigational Monoclonal Antibody, VIS410, in Subjects With Uncomplicated Influenza A

NCT ID: NCT02989194

Last Updated: 2022-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-06
• Study Completion Date: 2017-10-27

Brief Summary

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

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).

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

VIS410 low dose

Single intravenous fixed low dose of VIS410

Group Type: EXPERIMENTAL

VIS410 low dose

Intervention Type: DRUG

Single intravenous fixed low dose of VIS410

VIS410 high dose

Single intravenous fixed high dose of VIS410

Group Type: EXPERIMENTAL

VIS410 high dose

Intervention Type: DRUG

Single intravenous fixed high dose of VIS410

Placebo

Single intravenous placebo infusion

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Single intravenous infusion of placebo

Interventions

VIS410 low dose

Single intravenous fixed low dose of VIS410

Intervention Type: DRUG

VIS410 high dose

Single intravenous fixed high dose of VIS410

Intervention Type: DRUG

Placebo

Single intravenous infusion of placebo

Intervention Type: DRUG

Eligibility 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 (milli-international units/milliliter) 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biomedical Advanced Research and Development Authority

FED

Sponsor Role: collaborator

Visterra, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Development

Role: STUDY_DIRECTOR

Visterra, Inc.

Locations

Huntsville, Alabama, United States

Coral Gables, Florida, United States

Homestead, Florida, United States

Miami, Florida, United States

Miami, Florida, United States

Orlando, Florida, United States

Eunice, Louisiana, United States

New Orleans, Louisiana, United States

Shelby, North Carolina, United States

Houston, Texas, United States

McAllen, Texas, United States

Asenovgrad, , Bulgaria

Lom, , Bulgaria

Rousse, , Bulgaria

Sofia, , Bulgaria

Sofia, , Bulgaria

Velingrad, , Bulgaria

Paide, , Estonia

Tallinn, , Estonia

Tallinn, , Estonia

Tallinn, , Estonia

Daugavpils, , Latvia

Liepāja, , Latvia

Rēzekne, , Latvia

Riga, , Latvia

Valmiera, , Latvia

Ventspils, , Latvia

Kragujevac, , Serbia

Niš, , Serbia

Novi Sad, , Serbia

Welkom, Free State, South Africa

Benoni, Gauteng, South Africa

Centurion, Gauteng, South Africa

Johannesburg, Gauteng, South Africa

Kempton Park, Gauteng, South Africa

Pretoria, Gauteng, South Africa

Pretoria West, Gauteng, South Africa

Soshanguve, Gauteng, South Africa

Soweto, Gauteng, South Africa

Durban, KwaZulu-Natal, South Africa

Thabazimbi, Limpopo, South Africa

Middelburg, Mpumalanga, South Africa

Witbank, Mpumalanga, South Africa

Cape Town, Western Cape, South Africa

Worcester, Western Cape, South Africa

Kharkiv, , Ukraine

Kharkiv, , Ukraine

Kiev, , Ukraine

Kiev, , Ukraine

Kiev, , Ukraine

Odesa, , Ukraine

Sumy, , Ukraine

Vinnytsia, , Ukraine

Vinnytsia, , Ukraine

Countries

United States; Bulgaria; Estonia; Latvia; Serbia; South Africa; Ukraine

References

Hershberger E, Sloan S, Narayan K, Hay CA, Smith P, Engler F, Jeeninga R, Smits S, Trevejo J, Shriver Z, Oldach D. Safety and efficacy of monoclonal antibody VIS410 in adults with uncomplicated influenza A infection: Results from a randomized, double-blind, phase-2, placebo-controlled study. EBioMedicine. 2019 Feb;40:574-582. doi: 10.1016/j.ebiom.2018.12.051. Epub 2019 Jan 9.

Reference Type: RESULT

PMID: 30638863 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

VIS410-202

Identifier Type: -

Identifier Source: org_study_id