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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02989194

Enrollment

150

Registered

2016-12-12

Start date

2017-01-06

Completion date

2017-10-27

Last updated

2022-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

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).

Interventions

DRUGVIS410 low dose

Single intravenous fixed low dose of VIS410

DRUGVIS410 high dose

Single intravenous fixed high dose of VIS410

DRUGPlacebo

Single intravenous infusion of placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

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

Measure	Time frame	Description
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	The Influenza Patient Reported Outcome (FluPRO) questionnaire is a 32-question instrument that assesses the occurrence and intensity of influenza associated symptoms (scale of 0 to 4, with 0 representing no symptoms) over 24 hours (lower scores indicate better outcomes). FluPRO data were recorded by subjects at Baseline (Day 1), then daily thereafter through Day 10. These data were summarized at each visit by treatment group. The data below show the percent change in mean total symptom scores over time by treatment arm.
Hospitalization for Influenza-related Complications	100 days	Number of participants requiring hospitalization for influenza-related complications
Duration of Hospitalization for Complications of Influenza	100 days	Duration of hospitalization for participants with at least 1 complication of influenza. There were no participants hospitalized for complications of influenza.
Count of Participants With Complications of Influenza	100 days	Count of participants with at least 1 complication of influenza
Influenza A Relapse/Reinfection	100 days	Number of participants with influenza A relapse/reinfection
VIS410 Maximum Plasma Concentration	1, 3, 5, 7, 14, 28, 56, 100 days	The maximum observed concentration of VIS410 in serum (Cmax).
Pharmacokinetics of VIS410 Concentration in Serum	1, 3, 5, 7, 14, 28, 56, 100 days	Time corresponding to the maximum serum concentration of VIS410.
Peak Viral Load by TCID50	7 days	The difference between VIS410 and placebo treatment groups in peak viral load based on the half-maximal tissue culture infective dose (TCID50) from nasopharyngeal swab samples taken from the first 50 participants.
VIS410 Plasma Concentration (AUC 0-last)	1, 3, 5, 7, 14, 28, 56, 100 days	VIS410 area under the plasma concentration time curve in serum. AUC 0-last is the area under the plasma concentration time curve from time 0 to the last measurable concentration.
Half-life of VIS410 in Serum.	1, 3, 5, 7, 14, 28, 56, 100 days	Terminal elimination half-life of VIS410 in serum (t1/2) in serum.
Clearance (CL) of VIS410 in Serum.	1, 3, 5, 7, 14, 28, 56, 100 days	Summary of VIS410 total clearance (CL) in serum.
Area Under the Viral Load-Time Curve (VL AUC) From Nasopharyngeal Swab Day 7.	7 days	The difference between VIS410 and placebo treatment groups in viral AUC based on the half-maximal tissue culture infective dose (TCID50) from nasopharyngeal swab samples taken from the first 50 participants.
Summary of Anti-VIS410 Antibody (ADA) Titers.	100 days	Count of subjects testing positive for anti-VIS410 antibodies on days 1, 14, 56 and 100. A positive result includes samples confirmed positive and above titer cut point factor (and titer ≥ 1). Negative results include screened or confirmed negative or confirmed positive but below titer cut point factor (titer \< 1). For participants receiving placebo, only samples from two participants were tested at Days 14 and 56.
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	The Influenza Patient Reported Outcome (FluPRO) questionnaire is a 32-question instrument that assesses the occurrence and intensity of influenza associated symptoms (scale of 0 to 4, with 0 representing no symptoms) over 24 hours (lower scores indicate better outcomes). FluPRO data were recorded by subjects at Baseline (Day 1), then daily thereafter through Day 10. Data below show the time to symptom resolution for Total Symptom Score.
VIS410 Plasma Concentration ( AUC 0-infinity)	1, 3, 5, 7, 14, 28, 56, 100 days	VIS410 area under the plasma concentration time curve in serum. AUC 0-infinity is from the time of dosing extrapolated to infinity.
Time to Resolution of Peak Viral Load From Nasopharyngeal Samples by TCID50.	7 days	The number of days for the median time to resolution of peak viral load from end of infusion by nasopharyngeal swabs collected from the first 50 participants and tested by half maximal tissue culture infective dose (TCID50)

Countries

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

Participant flow

Recruitment details

This study was initiated in 58 study centers; 28 sites enrolled at least 1 subject.

Pre-assignment details

When required, subject may have been given a pre-screening informed consent to perform a Rapid Antigen Test for influenza. Flu-positive subjects were given a full explanation of the nature of the study and written informed consent (approved by local ethics committee) was obtained according to local requirements before any study related assessments

Participants by arm

Arm	Count
VIS410 High Dose Single intravenous fixed dose of 4000 mg VIS410	50
VIS410 Low Dose Single intravenous fixed dose of 2000 mg VIS410	50
Placebo Single intravenous saline solution	50
Total	150

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	0	1
Overall Study	Study on hold for safety and participant was withdrawn	1	0
Overall Study	Withdrawal by Subject	0	1

Baseline characteristics

Characteristic	VIS410 High Dose	Total	Placebo	VIS410 Low Dose
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	50 Participants	150 Participants	50 Participants	50 Participants
Age, Continuous	40.3 years STANDARD_DEVIATION 13.13	41.0 years STANDARD_DEVIATION 13.23	43.1 years STANDARD_DEVIATION 12.77	39.6 years STANDARD_DEVIATION 13.79
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants	35 Participants	13 Participants	12 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	40 Participants	115 Participants	37 Participants	38 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	1 Participants	3 Participants	1 Participants	1 Participants
Race (NIH/OMB) Black or African American	10 Participants	31 Participants	10 Participants	11 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants	4 Participants	3 Participants	0 Participants
Race (NIH/OMB) White	38 Participants	112 Participants	36 Participants	38 Participants
Region of Enrollment Bulgaria	0 participants	1 participants	1 participants	0 participants
Region of Enrollment Estonia	1 participants	3 participants	0 participants	2 participants
Region of Enrollment Latvia	6 participants	15 participants	7 participants	2 participants
Region of Enrollment South Africa	24 participants	73 participants	24 participants	25 participants
Region of Enrollment United States	19 participants	58 participants	18 participants	21 participants
Sex: Female, Male Female	27 Participants	84 Participants	28 Participants	29 Participants
Sex: Female, Male Male	23 Participants	66 Participants	22 Participants	21 Participants
Subjects Body Mass Index	29.01 kg/m^2	29.54 kg/m^2	28.82 kg/m^2	30.80 kg/m^2
Time since onset of influenza (hours)	27.69 hours	28.60 hours	28.07 hours	28.88 hours

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 49	0 / 49	0 / 50
other Total, other adverse events	16 / 49	10 / 49	7 / 50
serious Total, serious adverse events	0 / 49	0 / 49	2 / 50

Outcome results

Primary

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

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

Time frame: 100 days

Population: Safety Population The safety population included all subjects randomized who received IV study drug. The safety population summaries were based on the actual treatment received.

Arm	Measure	Group	Value (NUMBER)
VIS410 High Dose	Assess the Safety and Tolerability of a Single IV Dose of VIS410 in Participants With Uncomplicated Influenza Infection	Percentage of subjects with any adverse events	57.1 percentage of participants
VIS410 High Dose	Assess the Safety and Tolerability of a Single IV Dose of VIS410 in Participants With Uncomplicated Influenza Infection	Percentage of subjects with any serious adverse events	0 percentage of participants
VIS410 Low Dose	Assess the Safety and Tolerability of a Single IV Dose of VIS410 in Participants With Uncomplicated Influenza Infection	Percentage of subjects with any serious adverse events	0 percentage of participants
VIS410 Low Dose	Assess the Safety and Tolerability of a Single IV Dose of VIS410 in Participants With Uncomplicated Influenza Infection	Percentage of subjects with any adverse events	34.7 percentage of participants
VIS410 Total	Assess the Safety and Tolerability of a Single IV Dose of VIS410 in Participants With Uncomplicated Influenza Infection	Percentage of subjects with any serious adverse events	0 percentage of participants
VIS410 Total	Assess the Safety and Tolerability of a Single IV Dose of VIS410 in Participants With Uncomplicated Influenza Infection	Percentage of subjects with any adverse events	45.9 percentage of participants
Placebo	Assess the Safety and Tolerability of a Single IV Dose of VIS410 in Participants With Uncomplicated Influenza Infection	Percentage of subjects with any serious adverse events	4 percentage of participants
Placebo	Assess the Safety and Tolerability of a Single IV Dose of VIS410 in Participants With Uncomplicated Influenza Infection	Percentage of subjects with any adverse events	26.0 percentage of participants

Primary

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

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.

Time frame: 100 days

Population: Safety Population. The safety population included all participants randomized who received IV study drug. The safety population summaries were based on the actual treatment received.

Arm	Measure	Group	Value (NUMBER)
VIS410 High Dose	Percentage of Participants With Any Treatment-emergent Adverse Event (TEAE) and TEAEs of Special Interest	Percentage of subjects with any injection site AEs.	2.0 percentage of participants
VIS410 High Dose	Percentage of Participants With Any Treatment-emergent Adverse Event (TEAE) and TEAEs of Special Interest	Percentage of subjects with treatment related TEAEs	30.6 percentage of participants
VIS410 High Dose	Percentage of Participants With Any Treatment-emergent Adverse Event (TEAE) and TEAEs of Special Interest	Percentage of subjects with any TEAEs of Special Interest	34.7 percentage of participants
VIS410 High Dose	Percentage of Participants With Any Treatment-emergent Adverse Event (TEAE) and TEAEs of Special Interest	Percentage of Subjects with any hypersensitivity Reactions	0 percentage of participants
VIS410 High Dose	Percentage of Participants With Any Treatment-emergent Adverse Event (TEAE) and TEAEs of Special Interest	Percentage of subjects with any anaphylactic reactions	0 percentage of participants
VIS410 High Dose	Percentage of Participants With Any Treatment-emergent Adverse Event (TEAE) and TEAEs of Special Interest	Percentage of subjects with any TEAE	55.1 percentage of participants
VIS410 Low Dose	Percentage of Participants With Any Treatment-emergent Adverse Event (TEAE) and TEAEs of Special Interest	Percentage of subjects with any TEAE	34.7 percentage of participants
VIS410 Low Dose	Percentage of Participants With Any Treatment-emergent Adverse Event (TEAE) and TEAEs of Special Interest	Percentage of Subjects with any hypersensitivity Reactions	0 percentage of participants
VIS410 Low Dose	Percentage of Participants With Any Treatment-emergent Adverse Event (TEAE) and TEAEs of Special Interest	Percentage of subjects with any TEAEs of Special Interest	16.3 percentage of participants
VIS410 Low Dose	Percentage of Participants With Any Treatment-emergent Adverse Event (TEAE) and TEAEs of Special Interest	Percentage of subjects with any anaphylactic reactions	0 percentage of participants
VIS410 Low Dose	Percentage of Participants With Any Treatment-emergent Adverse Event (TEAE) and TEAEs of Special Interest	Percentage of subjects with treatment related TEAEs	14.3 percentage of participants
VIS410 Low Dose	Percentage of Participants With Any Treatment-emergent Adverse Event (TEAE) and TEAEs of Special Interest	Percentage of subjects with any injection site AEs.	0.0 percentage of participants
VIS410 Total	Percentage of Participants With Any Treatment-emergent Adverse Event (TEAE) and TEAEs of Special Interest	Percentage of subjects with treatment related TEAEs	22.4 percentage of participants
VIS410 Total	Percentage of Participants With Any Treatment-emergent Adverse Event (TEAE) and TEAEs of Special Interest	Percentage of subjects with any injection site AEs.	1.0 percentage of participants
VIS410 Total	Percentage of Participants With Any Treatment-emergent Adverse Event (TEAE) and TEAEs of Special Interest	Percentage of subjects with any TEAEs of Special Interest	25.5 percentage of participants
VIS410 Total	Percentage of Participants With Any Treatment-emergent Adverse Event (TEAE) and TEAEs of Special Interest	Percentage of Subjects with any hypersensitivity Reactions	0 percentage of participants
VIS410 Total	Percentage of Participants With Any Treatment-emergent Adverse Event (TEAE) and TEAEs of Special Interest	Percentage of subjects with any anaphylactic reactions	0 percentage of participants
VIS410 Total	Percentage of Participants With Any Treatment-emergent Adverse Event (TEAE) and TEAEs of Special Interest	Percentage of subjects with any TEAE	44.9 percentage of participants
Placebo	Percentage of Participants With Any Treatment-emergent Adverse Event (TEAE) and TEAEs of Special Interest	Percentage of subjects with any TEAEs of Special Interest	12 percentage of participants
Placebo	Percentage of Participants With Any Treatment-emergent Adverse Event (TEAE) and TEAEs of Special Interest	Percentage of subjects with any injection site AEs.	0 percentage of participants
Placebo	Percentage of Participants With Any Treatment-emergent Adverse Event (TEAE) and TEAEs of Special Interest	Percentage of subjects with treatment related TEAEs	12.0 percentage of participants
Placebo	Percentage of Participants With Any Treatment-emergent Adverse Event (TEAE) and TEAEs of Special Interest	Percentage of subjects with any TEAE	24.0 percentage of participants
Placebo	Percentage of Participants With Any Treatment-emergent Adverse Event (TEAE) and TEAEs of Special Interest	Percentage of subjects with any anaphylactic reactions	0 percentage of participants
Placebo	Percentage of Participants With Any Treatment-emergent Adverse Event (TEAE) and TEAEs of Special Interest	Percentage of Subjects with any hypersensitivity Reactions	0 percentage of participants

Secondary

Area Under the Viral Load-Time Curve (VL AUC) From Nasopharyngeal Swab Day 7.

The difference between VIS410 and placebo treatment groups in viral AUC based on the half-maximal tissue culture infective dose (TCID50) from nasopharyngeal swab samples taken from the first 50 participants.

Time frame: 7 days

Population: Modified Intent-to-Treat Population The modified intent-to-treat (mITT) population included all subjects who received IV study drug and were confirmed influenza A positive by a molecular test at the central virological laboratory.

Arm	Measure	Value (MEDIAN)
VIS410 High Dose	Area Under the Viral Load-Time Curve (VL AUC) From Nasopharyngeal Swab Day 7.	3.726 d x log10 TCID50/mL
VIS410 Low Dose	Area Under the Viral Load-Time Curve (VL AUC) From Nasopharyngeal Swab Day 7.	3.570 d x log10 TCID50/mL
VIS410 Total	Area Under the Viral Load-Time Curve (VL AUC) From Nasopharyngeal Swab Day 7.	3.660 d x log10 TCID50/mL
Placebo	Area Under the Viral Load-Time Curve (VL AUC) From Nasopharyngeal Swab Day 7.	4.782 d x log10 TCID50/mL

Comparison: A t-test was used to assess the difference between the VIS410 total and placebo treatment groups from nasopharyngeal swabs based on the TCID50.p-value: 0.083t-test, 2 sided

Secondary

Clearance (CL) of VIS410 in Serum.

Summary of VIS410 total clearance (CL) in serum.

Time frame: 1, 3, 5, 7, 14, 28, 56, 100 days

Population: The PK population included all subjects who received IV study drug and had at least 1 PK concentration that could be calculated.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
VIS410 High Dose	Clearance (CL) of VIS410 in Serum.	465.175 mL/day	Geometric Coefficient of Variation 38.3172
VIS410 Low Dose	Clearance (CL) of VIS410 in Serum.	372.302 mL/day	Geometric Coefficient of Variation 30.0631

Secondary

Count of Participants With Complications of Influenza

Count of participants with at least 1 complication of influenza

Time frame: 100 days

Population: Modified Intent-to-Treat Population. The modified intent-to-treat (mITT) population included all subjects who received IV study drug and were confirmed influenza A positive by a molecular test at the central virological laboratory.

Arm	Measure	Value (NUMBER)
VIS410 High Dose	Count of Participants With Complications of Influenza	1 participants
VIS410 Low Dose	Count of Participants With Complications of Influenza	3 participants
VIS410 Total	Count of Participants With Complications of Influenza	4 participants
Placebo	Count of Participants With Complications of Influenza	3 participants

Secondary

Duration of Hospitalization for Complications of Influenza

Duration of hospitalization for participants with at least 1 complication of influenza. There were no participants hospitalized for complications of influenza.

Time frame: 100 days

Arm	Measure	Value (NUMBER)
VIS410 High Dose	Duration of Hospitalization for Complications of Influenza	0 days
VIS410 Low Dose	Duration of Hospitalization for Complications of Influenza	0 days
VIS410 Total	Duration of Hospitalization for Complications of Influenza	0 days
Placebo	Duration of Hospitalization for Complications of Influenza	0 days

Secondary

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

The Influenza Patient Reported Outcome (FluPRO) questionnaire is a 32-question instrument that assesses the occurrence and intensity of influenza associated symptoms (scale of 0 to 4, with 0 representing no symptoms) over 24 hours (lower scores indicate better outcomes). FluPRO data were recorded by subjects at Baseline (Day 1), then daily thereafter through Day 10. Data below show the time to symptom resolution for Total Symptom Score.

Time frame: 10 days

Arm	Measure	Value (MEDIAN)
VIS410 High Dose	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	2.7 days
VIS410 Low Dose	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	2.0 days
VIS410 Total	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	2.1 days
Placebo	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	2.6 days

Comparison: All null hypotheses were defined as no treatment difference.p-value: 0.173Log Rank

Secondary

Half-life of VIS410 in Serum.

Terminal elimination half-life of VIS410 in serum (t1/2) in serum.

Time frame: 1, 3, 5, 7, 14, 28, 56, 100 days

Population: The PK population included all subjects who received IV study drug and had at least 1 PK concentration that could be calculated

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
VIS410 High Dose	Half-life of VIS410 in Serum.	9.941 day	Geometric Coefficient of Variation 40.6241
VIS410 Low Dose	Half-life of VIS410 in Serum.	10.119 day	Geometric Coefficient of Variation 34.2559

Secondary

Hospitalization for Influenza-related Complications

Number of participants requiring hospitalization for influenza-related complications

Time frame: 100 days

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
VIS410 High Dose	Hospitalization for Influenza-related Complications	0 Participants
VIS410 Low Dose	Hospitalization for Influenza-related Complications	0 Participants
VIS410 Total	Hospitalization for Influenza-related Complications	0 Participants
Placebo	Hospitalization for Influenza-related Complications	0 Participants

Secondary

Influenza A Relapse/Reinfection

Number of participants with influenza A relapse/reinfection

Time frame: 100 days

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
VIS410 High Dose	Influenza A Relapse/Reinfection	0 Participants
VIS410 Low Dose	Influenza A Relapse/Reinfection	0 Participants
VIS410 Total	Influenza A Relapse/Reinfection	0 Participants
Placebo	Influenza A Relapse/Reinfection	0 Participants

Secondary

Peak Viral Load by TCID50

The difference between VIS410 and placebo treatment groups in peak viral load based on the half-maximal tissue culture infective dose (TCID50) from nasopharyngeal swab samples taken from the first 50 participants.

Time frame: 7 days

Arm	Measure	Value (MEDIAN)
VIS410 High Dose	Peak Viral Load by TCID50	3.125 log10 TCID50/mL
VIS410 Low Dose	Peak Viral Load by TCID50	2.50 log10 TCID50/mL
VIS410 Total	Peak Viral Load by TCID50	2.625 log10 TCID50/mL
Placebo	Peak Viral Load by TCID50	3.375 log10 TCID50/mL

Comparison: The null hypothesis was defined as no treatment difference.p-value: 0.169t-test, 2 sided

Secondary

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

The Influenza Patient Reported Outcome (FluPRO) questionnaire is a 32-question instrument that assesses the occurrence and intensity of influenza associated symptoms (scale of 0 to 4, with 0 representing no symptoms) over 24 hours (lower scores indicate better outcomes). FluPRO data were recorded by subjects at Baseline (Day 1), then daily thereafter through Day 10. These data were summarized at each visit by treatment group. The data below show the percent change in mean total symptom scores over time by treatment arm.

Time frame: 10 days

Arm	Measure	Group	Value (MEAN)	Dispersion
VIS410 High Dose	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	Percent Change from Baseline to Day 2	-26.12 Percent Change	Standard Deviation 27
VIS410 High Dose	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	Percentage change from baseline to day 3	-38.65 Percent Change	Standard Deviation 28.78
VIS410 High Dose	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	Percentage change from baseline to day 4	-53.46 Percent Change	Standard Deviation 26.16
VIS410 High Dose	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	Percentage change from baseline to day 5	-60.85 Percent Change	Standard Deviation 25.52
VIS410 High Dose	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	Percentage change from baseline to day 6	-69.31 Percent Change	Standard Deviation 20.9
VIS410 High Dose	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	Percentage change from baseline to day 7	-74.03 Percent Change	Standard Deviation 19.31
VIS410 High Dose	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	Percentage change from baseline to day 10	-82.30 Percent Change	Standard Deviation 20.07
VIS410 High Dose	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	Percentage change from baseline to day 8	-77.98 Percent Change	Standard Deviation 20.76
VIS410 High Dose	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	Percentage change from baseline to day 9	-80.05 Percent Change	Standard Deviation 19.78
VIS410 Low Dose	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	Percentage change from baseline to day 4	-59.08 Percent Change	Standard Deviation 31.12
VIS410 Low Dose	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	Percentage change from baseline to day 5	-64.61 Percent Change	Standard Deviation 29.91
VIS410 Low Dose	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	Percentage change from baseline to day 6	-66.80 Percent Change	Standard Deviation 33.42
VIS410 Low Dose	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	Percentage change from baseline to day 8	-76.03 Percent Change	Standard Deviation 25.53
VIS410 Low Dose	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	Percentage change from baseline to day 7	-70.76 Percent Change	Standard Deviation 31.18
VIS410 Low Dose	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	Percentage change from baseline to day 9	-78.48 Percent Change	Standard Deviation 25.95
VIS410 Low Dose	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	Percentage change from baseline to day 10	-81.38 Percent Change	Standard Deviation 20.43
VIS410 Low Dose	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	Percent Change from Baseline to Day 2	-29.98 Percent Change	Standard Deviation 29.55
VIS410 Low Dose	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	Percentage change from baseline to day 3	-49.37 Percent Change	Standard Deviation 29.62
VIS410 Total	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	Percentage change from baseline to day 6	-68.08 Percent Change	Standard Deviation 27.61
VIS410 Total	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	Percentage change from baseline to day 7	-72.43 Percent Change	Standard Deviation 25.71
VIS410 Total	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	Percentage change from baseline to day 3	-43.89 Percent Change	Standard Deviation 29.53
VIS410 Total	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	Percentage change from baseline to day 9	-79.27 Percent Change	Standard Deviation 22.91
VIS410 Total	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	Percentage change from baseline to day 8	-77.02 Percent Change	Standard Deviation 23.13
VIS410 Total	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	Percentage change from baseline to day 10	-81.85 Percent Change	Standard Deviation 20.14
VIS410 Total	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	Percentage change from baseline to day 4	-56.21 Percent Change	Standard Deviation 28.67
VIS410 Total	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	Percentage change from baseline to day 5	-62.69 Percent Change	Standard Deviation 27.66
VIS410 Total	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	Percent Change from Baseline to Day 2	-28.01 Percent Change	Standard Deviation 28.18
Placebo	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	Percentage change from baseline to day 5	-56.75 Percent Change	Standard Deviation 24.31
Placebo	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	Percent Change from Baseline to Day 2	-19.53 Percent Change	Standard Deviation 26.51
Placebo	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	Percentage change from baseline to day 10	-84.35 Percent Change	Standard Deviation 17.52
Placebo	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	Percentage change from baseline to day 4	-44.55 Percent Change	Standard Deviation 28.2
Placebo	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	Percentage change from baseline to day 7	-71.51 Percent Change	Standard Deviation 20.61
Placebo	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	Percentage change from baseline to day 8	-76.16 Percent Change	Standard Deviation 21.01
Placebo	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	Percentage change from baseline to day 9	-79.52 Percent Change	Standard Deviation 19.84
Placebo	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	Percentage change from baseline to day 6	64.01 Percent Change	Standard Deviation 23.35
Placebo	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	Percentage change from baseline to day 3	-33.63 Percent Change	Standard Deviation 23.6

Comparison: Percent Change from Baseline to Day 2. All null hypotheses were defined as no treatment difference.p-value: 0.158Wilcoxon (Mann-Whitney)

Comparison: Percent Change from Baseline to Day 3. All null hypotheses were defined as no treatment difference.p-value: 0.025Wilcoxon (Mann-Whitney)

Comparison: Percent Change from Baseline to Day 4. All null hypotheses were defined as no treatment difference.p-value: 0.007Wilcoxon (Mann-Whitney)

Comparison: Percent Change from Baseline to Day 5. All null hypotheses were defined as no treatment difference.p-value: 0.061Wilcoxon (Mann-Whitney)

Comparison: Percent Change from Baseline to Day 6. All null hypotheses were defined as no treatment difference.p-value: 0.107Wilcoxon (Mann-Whitney)

Comparison: Percent Change from Baseline to Day 7. All null hypotheses were defined as no treatment difference.p-value: 0.237Wilcoxon (Mann-Whitney)

Comparison: Percent Change from Baseline to Day 8. All null hypotheses were defined as no treatment difference.p-value: 0.497Wilcoxon (Mann-Whitney)

Comparison: Percent Change from Baseline to Day 9. All null hypotheses were defined as no treatment difference.p-value: 0.704Wilcoxon (Mann-Whitney)

Comparison: Percent Change from Baseline to Day 10. All null hypotheses were defined as no treatment difference.p-value: 0.585Wilcoxon (Mann-Whitney)

Secondary

Pharmacokinetics of VIS410 Concentration in Serum

Time corresponding to the maximum serum concentration of VIS410.

Time frame: 1, 3, 5, 7, 14, 28, 56, 100 days

Population: The PK population included all subjects who received IV study drug and had at least 1 PK concentration that could be calculated

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
VIS410 High Dose	Pharmacokinetics of VIS410 Concentration in Serum	0.119 day	Geometric Coefficient of Variation 79.0624
VIS410 Low Dose	Pharmacokinetics of VIS410 Concentration in Serum	0.133 day	Geometric Coefficient of Variation 131.4255

Secondary

Summary of Anti-VIS410 Antibody (ADA) Titers.

Count of subjects testing positive for anti-VIS410 antibodies on days 1, 14, 56 and 100. A positive result includes samples confirmed positive and above titer cut point factor (and titer ≥ 1). Negative results include screened or confirmed negative or confirmed positive but below titer cut point factor (titer \< 1). For participants receiving placebo, only samples from two participants were tested at Days 14 and 56.

Time frame: 100 days

Population: Safety Population The safety population included all ITT subjects who received IV study drug. The safety population summaries were based on the actual treatment received. Not all participants had samples for all timepoints. For participants receiving placebo, all participants were tested on Day 1 and Day 100; only samples from two participants were tested at Days 14 and 56.

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
VIS410 High Dose	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 100 anti-VIS410 antibody titer	ADA Titer ≤ 1	32 Participants
VIS410 High Dose	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 56 anti-VIS410 antibody titer	ADA Titer > 1 to 4	5 Participants
VIS410 High Dose	Summary of Anti-VIS410 Antibody (ADA) Titers.	Visit day 1 anti-VIS410 antibody titer	ADA Titer > 16 to 64	0 Participants
VIS410 High Dose	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 56 anti-VIS410 antibody titer	ADA Titer > 64	0 Participants
VIS410 High Dose	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 56 anti-VIS410 antibody titer	ADA Titer > 4 to 16	1 Participants
VIS410 High Dose	Summary of Anti-VIS410 Antibody (ADA) Titers.	Visit day 1 anti-VIS410 antibody titer	ADA Titer ≤ 1	45 Participants
VIS410 High Dose	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 56 anti-VIS410 antibody titer	ADA Titer > 16 to 64	1 Participants
VIS410 High Dose	Summary of Anti-VIS410 Antibody (ADA) Titers.	Visit day 1 anti-VIS410 antibody titer	ADA Titer > 1 to 4	3 Participants
VIS410 High Dose	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 100 anti-VIS410 antibody titer	ADA Titer > 16 to 64	1 Participants
VIS410 High Dose	Summary of Anti-VIS410 Antibody (ADA) Titers.	Visit day 1 anti-VIS410 antibody titer	ADA Titer > 64	0 Participants
VIS410 High Dose	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 14 anti-VIS410 antibody titer	ADA Titer ≤ 1	46 Participants
VIS410 High Dose	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 100 anti-VIS410 antibody titer	ADA Titer > 4 to 16	10 Participants
VIS410 High Dose	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 14 anti-VIS410 antibody titer	ADA Titer > 1 to 4	2 Participants
VIS410 High Dose	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 100 anti-VIS410 antibody titer	ADA Titer > 64	0 Participants
VIS410 High Dose	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 14 anti-VIS410 antibody titer	ADA Titer > 4 to 16	1 Participants
VIS410 High Dose	Summary of Anti-VIS410 Antibody (ADA) Titers.	Visit day 1 anti-VIS410 antibody titer	ADA Titer > 4 to 16	1 Participants
VIS410 High Dose	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 100 anti-VIS410 antibody titer	ADA Titer > 1 to 4	6 Participants
VIS410 High Dose	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 14 anti-VIS410 antibody titer	ADA Titer > 16 to 64	0 Participants
VIS410 High Dose	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 14 anti-VIS410 antibody titer	ADA Titer > 64	0 Participants
VIS410 High Dose	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 56 anti-VIS410 antibody titer	ADA Titer ≤ 1	42 Participants
VIS410 Low Dose	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 100 anti-VIS410 antibody titer	ADA Titer ≤ 1	26 Participants
VIS410 Low Dose	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 56 anti-VIS410 antibody titer	ADA Titer ≤ 1	34 Participants
VIS410 Low Dose	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 100 anti-VIS410 antibody titer	ADA Titer > 16 to 64	2 Participants
VIS410 Low Dose	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 56 anti-VIS410 antibody titer	ADA Titer > 64	0 Participants
VIS410 Low Dose	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 14 anti-VIS410 antibody titer	ADA Titer ≤ 1	43 Participants
VIS410 Low Dose	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 56 anti-VIS410 antibody titer	ADA Titer > 1 to 4	8 Participants
VIS410 Low Dose	Summary of Anti-VIS410 Antibody (ADA) Titers.	Visit day 1 anti-VIS410 antibody titer	ADA Titer ≤ 1	43 Participants
VIS410 Low Dose	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 100 anti-VIS410 antibody titer	ADA Titer > 64	0 Participants
VIS410 Low Dose	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 14 anti-VIS410 antibody titer	ADA Titer > 64	0 Participants
VIS410 Low Dose	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 56 anti-VIS410 antibody titer	ADA Titer > 4 to 16	3 Participants
VIS410 Low Dose	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 14 anti-VIS410 antibody titer	ADA Titer > 1 to 4	3 Participants
VIS410 Low Dose	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 56 anti-VIS410 antibody titer	ADA Titer > 16 to 64	3 Participants
VIS410 Low Dose	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 14 anti-VIS410 antibody titer	ADA Titer > 16 to 64	0 Participants
VIS410 Low Dose	Summary of Anti-VIS410 Antibody (ADA) Titers.	Visit day 1 anti-VIS410 antibody titer	ADA Titer > 16 to 64	0 Participants
VIS410 Low Dose	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 100 anti-VIS410 antibody titer	ADA Titer > 1 to 4	8 Participants
VIS410 Low Dose	Summary of Anti-VIS410 Antibody (ADA) Titers.	Visit day 1 anti-VIS410 antibody titer	ADA Titer > 4 to 16	1 Participants
VIS410 Low Dose	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 14 anti-VIS410 antibody titer	ADA Titer > 4 to 16	1 Participants
VIS410 Low Dose	Summary of Anti-VIS410 Antibody (ADA) Titers.	Visit day 1 anti-VIS410 antibody titer	ADA Titer > 64	0 Participants
VIS410 Low Dose	Summary of Anti-VIS410 Antibody (ADA) Titers.	Visit day 1 anti-VIS410 antibody titer	ADA Titer > 1 to 4	3 Participants
VIS410 Low Dose	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 100 anti-VIS410 antibody titer	ADA Titer > 4 to 16	11 Participants
VIS410 Total	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 56 anti-VIS410 antibody titer	ADA Titer > 4 to 16	4 Participants
VIS410 Total	Summary of Anti-VIS410 Antibody (ADA) Titers.	Visit day 1 anti-VIS410 antibody titer	ADA Titer ≤ 1	88 Participants
VIS410 Total	Summary of Anti-VIS410 Antibody (ADA) Titers.	Visit day 1 anti-VIS410 antibody titer	ADA Titer > 1 to 4	6 Participants
VIS410 Total	Summary of Anti-VIS410 Antibody (ADA) Titers.	Visit day 1 anti-VIS410 antibody titer	ADA Titer > 4 to 16	2 Participants
VIS410 Total	Summary of Anti-VIS410 Antibody (ADA) Titers.	Visit day 1 anti-VIS410 antibody titer	ADA Titer > 16 to 64	0 Participants
VIS410 Total	Summary of Anti-VIS410 Antibody (ADA) Titers.	Visit day 1 anti-VIS410 antibody titer	ADA Titer > 64	0 Participants
VIS410 Total	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 14 anti-VIS410 antibody titer	ADA Titer ≤ 1	89 Participants
VIS410 Total	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 14 anti-VIS410 antibody titer	ADA Titer > 1 to 4	5 Participants
VIS410 Total	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 14 anti-VIS410 antibody titer	ADA Titer > 4 to 16	2 Participants
VIS410 Total	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 14 anti-VIS410 antibody titer	ADA Titer > 16 to 64	0 Participants
VIS410 Total	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 14 anti-VIS410 antibody titer	ADA Titer > 64	0 Participants
VIS410 Total	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 56 anti-VIS410 antibody titer	ADA Titer ≤ 1	76 Participants
VIS410 Total	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 56 anti-VIS410 antibody titer	ADA Titer > 1 to 4	13 Participants
VIS410 Total	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 56 anti-VIS410 antibody titer	ADA Titer > 16 to 64	4 Participants
VIS410 Total	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 56 anti-VIS410 antibody titer	ADA Titer > 64	0 Participants
VIS410 Total	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 100 anti-VIS410 antibody titer	ADA Titer ≤ 1	58 Participants
VIS410 Total	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 100 anti-VIS410 antibody titer	ADA Titer > 1 to 4	14 Participants
VIS410 Total	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 100 anti-VIS410 antibody titer	ADA Titer > 4 to 16	21 Participants
VIS410 Total	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 100 anti-VIS410 antibody titer	ADA Titer > 16 to 64	3 Participants
VIS410 Total	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 100 anti-VIS410 antibody titer	ADA Titer > 64	0 Participants
Placebo	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 14 anti-VIS410 antibody titer	ADA Titer > 64	0 Participants
Placebo	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 14 anti-VIS410 antibody titer	ADA Titer > 16 to 64	0 Participants
Placebo	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 100 anti-VIS410 antibody titer	ADA Titer > 16 to 64	0 Participants
Placebo	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 100 anti-VIS410 antibody titer	ADA Titer ≤ 1	47 Participants
Placebo	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 14 anti-VIS410 antibody titer	ADA Titer > 4 to 16	0 Participants
Placebo	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 14 anti-VIS410 antibody titer	ADA Titer > 1 to 4	1 Participants
Placebo	Summary of Anti-VIS410 Antibody (ADA) Titers.	Visit day 1 anti-VIS410 antibody titer	ADA Titer > 1 to 4	4 Participants
Placebo	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 100 anti-VIS410 antibody titer	ADA Titer > 1 to 4	3 Participants
Placebo	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 14 anti-VIS410 antibody titer	ADA Titer ≤ 1	1 Participants
Placebo	Summary of Anti-VIS410 Antibody (ADA) Titers.	Visit day 1 anti-VIS410 antibody titer	ADA Titer > 64	0 Participants
Placebo	Summary of Anti-VIS410 Antibody (ADA) Titers.	Visit day 1 anti-VIS410 antibody titer	ADA Titer ≤ 1	45 Participants
Placebo	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 100 anti-VIS410 antibody titer	ADA Titer > 4 to 16	0 Participants
Placebo	Summary of Anti-VIS410 Antibody (ADA) Titers.	Visit day 1 anti-VIS410 antibody titer	ADA Titer > 16 to 64	0 Participants
Placebo	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 56 anti-VIS410 antibody titer	ADA Titer > 4 to 16	0 Participants
Placebo	Summary of Anti-VIS410 Antibody (ADA) Titers.	Visit day 1 anti-VIS410 antibody titer	ADA Titer > 4 to 16	0 Participants
Placebo	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 56 anti-VIS410 antibody titer	ADA Titer > 16 to 64	0 Participants
Placebo	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 56 anti-VIS410 antibody titer	ADA Titer > 1 to 4	0 Participants
Placebo	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 56 anti-VIS410 antibody titer	ADA Titer ≤ 1	2 Participants
Placebo	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 100 anti-VIS410 antibody titer	ADA Titer > 64	0 Participants
Placebo	Summary of Anti-VIS410 Antibody (ADA) Titers.	Day 56 anti-VIS410 antibody titer	ADA Titer > 64	0 Participants

Secondary

Time to Resolution of Peak Viral Load From Nasopharyngeal Samples by TCID50.

The number of days for the median time to resolution of peak viral load from end of infusion by nasopharyngeal swabs collected from the first 50 participants and tested by half maximal tissue culture infective dose (TCID50)

Time frame: 7 days

Arm	Measure	Value (MEDIAN)
VIS410 High Dose	Time to Resolution of Peak Viral Load From Nasopharyngeal Samples by TCID50.	2.0 days
VIS410 Low Dose	Time to Resolution of Peak Viral Load From Nasopharyngeal Samples by TCID50.	1.9 days
VIS410 Total	Time to Resolution of Peak Viral Load From Nasopharyngeal Samples by TCID50.	1.9 days
Placebo	Time to Resolution of Peak Viral Load From Nasopharyngeal Samples by TCID50.	3.6 days

Comparison: Kaplan-Meier methods were used to calculate the median time. All null hypotheses were defined as no treatment difference.p-value: 0.028Log Rank

Secondary

VIS410 Maximum Plasma Concentration

The maximum observed concentration of VIS410 in serum (Cmax).

Time frame: 1, 3, 5, 7, 14, 28, 56, 100 days

Population: The Pharmacokinetics (PK) population included all subjects who received IV study drug and had at least 1 PK concentration that could be calculated

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
VIS410 High Dose	VIS410 Maximum Plasma Concentration	1013.559 mcg/mL	Geometric Coefficient of Variation 35.5
VIS410 Low Dose	VIS410 Maximum Plasma Concentration	627.640 mcg/mL	Geometric Coefficient of Variation 54.6

Secondary

VIS410 Plasma Concentration ( AUC 0-infinity)

VIS410 area under the plasma concentration time curve in serum. AUC 0-infinity is from the time of dosing extrapolated to infinity.

Time frame: 1, 3, 5, 7, 14, 28, 56, 100 days

Population: The PK population included all subjects who received IV study drug and had at least 1 PK concentration that could be calculated

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
VIS410 High Dose	VIS410 Plasma Concentration ( AUC 0-infinity)	8598.909 day*mcg/mL	Geometric Coefficient of Variation 38.3172
VIS410 Low Dose	VIS410 Plasma Concentration ( AUC 0-infinity)	5371.988 day*mcg/mL	Geometric Coefficient of Variation 30.0631

Secondary

VIS410 Plasma Concentration (AUC 0-last)

VIS410 area under the plasma concentration time curve in serum. AUC 0-last is the area under the plasma concentration time curve from time 0 to the last measurable concentration.

Time frame: 1, 3, 5, 7, 14, 28, 56, 100 days

Population: The PK population included all subjects who received IV study drug and had at least 1 PK concentration that could be calculated

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
VIS410 High Dose	VIS410 Plasma Concentration (AUC 0-last)	8441.244 day*mcg/mL	Geometric Coefficient of Variation 39.5852
VIS410 Low Dose	VIS410 Plasma Concentration (AUC 0-last)	5385.491 day*mcg/mL	Geometric Coefficient of Variation 31.2065

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026

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

Conditions

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

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

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

Area Under the Viral Load-Time Curve (VL AUC) From Nasopharyngeal Swab Day 7.

Clearance (CL) of VIS410 in Serum.

Count of Participants With Complications of Influenza

Duration of Hospitalization for Complications of Influenza

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

Half-life of VIS410 in Serum.

Hospitalization for Influenza-related Complications

Influenza A Relapse/Reinfection

Peak Viral Load by TCID50

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

Pharmacokinetics of VIS410 Concentration in Serum

Summary of Anti-VIS410 Antibody (ADA) Titers.

Time to Resolution of Peak Viral Load From Nasopharyngeal Samples by TCID50.

VIS410 Maximum Plasma Concentration

VIS410 Plasma Concentration ( AUC 0-infinity)

VIS410 Plasma Concentration (AUC 0-last)