Clinical Trials/NCT02989194

NCT02989194

Completed

Phase 2

A Phase 2a Double-blind, Placebo-controlled Study to Assess the Safety and Tolerability of a Single Intravenous Dose of an Investigational Monoclonal Antibody With Code Name VIS410 in Subjects With Uncomplicated Influenza A Infection

Visterra, Inc.0 sites150 target enrollmentJanuary 6, 2017

ConditionsInfluenza

InterventionsVIS410 low dose VIS410 high dose Placebo

DrugsVIS410 low dose VIS410 high dose Placebo

Overview

Phase: Phase 2
Intervention: VIS410 low dose
Conditions: Influenza
Sponsor: Visterra, Inc.
Enrollment: 150
Primary Endpoint: Assess the Safety and Tolerability of a Single IV Dose of VIS410 in Participants With Uncomplicated Influenza Infection
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

January 6, 2017

End Date

October 27, 2017

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Visterra, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male and female subjects aged ≥18 years and ˂65 years
•Women should fulfill one of the following criteria:
•Post-menopausal; either amenorrhea ≥12 months or follicle stimulating hormone \>40 mIU/mL (milli-international units/milliliter) as documented in their medical history
•Surgically sterile; hysterectomy, bilateral oophorectomy, or tubal ligation
•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

Arms & Interventions

VIS410 low dose

Single intravenous fixed low dose of VIS410

Intervention: VIS410 low dose

VIS410 high dose

Single intravenous fixed high dose of VIS410

Intervention: VIS410 high dose

Placebo

Single intravenous placebo infusion

Intervention: Placebo

Outcomes

Primary Outcomes

Assess the Safety and Tolerability of a Single IV Dose of VIS410 in Participants With Uncomplicated Influenza Infection

Time Frame: 100 days

The percentage of participants with adverse events (AEs) and serious adverse events (SAEs) following administration of a single dose of IV VIS410.

Percentage of Participants With Any Treatment-emergent Adverse Event (TEAE) and TEAEs of Special Interest

Time Frame: 100 days

Percentage of participants experiencing any TEAE, TEAEs considered related to study treatment and the number of participants experiencing adverse events of special interest (AESI). A TEAE is defined as an adverse event that starts on or after the date of study drug IV infusion. AESIs included hypersensitivity reaction, anaphylactic reaction, or injection site adverse event.

Secondary Outcomes

Clearance (CL) of VIS410 in Serum.(1, 3, 5, 7, 14, 28, 56, 100 days)
Peak Viral Load by TCID50(7 days)
Time to Resolution of Peak Viral Load From Nasopharyngeal Samples by TCID50.(7 days)
Percentage Change From Baseline in Signs and Symptoms of Influenza-like Illness as Assessed by the Influenza Patient Reported Outcomes Questionnaire After a Single IV Dose of VIS410(10 days)
Influenza A Relapse/Reinfection(100 days)
VIS410 Plasma Concentration (AUC 0-last)(1, 3, 5, 7, 14, 28, 56, 100 days)
Half-life of VIS410 in Serum.(1, 3, 5, 7, 14, 28, 56, 100 days)
Area Under the Viral Load-Time Curve (VL AUC) From Nasopharyngeal Swab Day 7.(7 days)
Summary of Anti-VIS410 Antibody (ADA) Titers.(100 days)
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(10 days)
Hospitalization for Influenza-related Complications(100 days)
Count of Participants With Complications of Influenza(100 days)
VIS410 Maximum Plasma Concentration(1, 3, 5, 7, 14, 28, 56, 100 days)
Pharmacokinetics of VIS410 Concentration in Serum(1, 3, 5, 7, 14, 28, 56, 100 days)
Duration of Hospitalization for Complications of Influenza(100 days)
VIS410 Plasma Concentration ( AUC 0-infinity)(1, 3, 5, 7, 14, 28, 56, 100 days)