Trial Outcomes & Findings for First in Human Study to Assess Safety of VIS649 in Healthy Subjects (NCT NCT03719443)
NCT ID: NCT03719443
Last Updated: 2026-05-01
Results Overview
The number adverse events (AEs), serious adverse events (SAEs), and drug related events following administration of VIS649. Safety will be assessed via AE severity per CTCAE v4.0
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
51 participants
Primary outcome timeframe
Baseline to day 112
Results posted on
2026-05-01
Participant Flow
Recruitment was done for a single clinical site.
No notable events took place between participant enrollment and assignment.
Participant milestones
| Measure |
Pooled Placebo
Single IV dose of placebo will be administered via IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 1
A single dose (0.5 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 2
A single dose (2.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 3
A single dose (6.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 4
A single dose (12 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Placebo Cohort 5 + Vaccine
Single dose of placebo followed by single dose of vaccine
|
VIS649 Cohort 5 + Vaccine
Single dose of 6.0 mg/kg VIS649 followed by single dose of vaccine
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
7
|
7
|
7
|
7
|
5
|
10
|
|
Overall Study
COMPLETED
|
8
|
7
|
5
|
7
|
6
|
5
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
0
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Pooled Placebo
Single IV dose of placebo will be administered via IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 1
A single dose (0.5 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 2
A single dose (2.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 3
A single dose (6.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 4
A single dose (12 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Placebo Cohort 5 + Vaccine
Single dose of placebo followed by single dose of vaccine
|
VIS649 Cohort 5 + Vaccine
Single dose of 6.0 mg/kg VIS649 followed by single dose of vaccine
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
First in Human Study to Assess Safety of VIS649 in Healthy Subjects
Baseline characteristics by cohort
| Measure |
Pooled Placebo
n=8 Participants
Single IV dose of placebo will be administered via IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 1
n=7 Participants
A single dose (0.5 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 2
n=7 Participants
A single dose (2.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 3
n=7 Participants
A single dose (6.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 4
n=7 Participants
A single dose (12 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Placebo Cohort 5 + Vaccine
n=5 Participants
Single dose of placebo followed by single dose of vaccine
|
VIS649 Cohort 5 + Vaccine
n=10 Participants
Single dose of 6.0 mg/kg VIS649 followed by single dose of vaccine
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
32.6 years
STANDARD_DEVIATION 9.24 • n=14 Participants
|
29.4 years
STANDARD_DEVIATION 6.70 • n=34 Participants
|
40.4 years
STANDARD_DEVIATION 11.70 • n=69 Participants
|
41.0 years
STANDARD_DEVIATION 9.63 • n=140 Participants
|
40.9 years
STANDARD_DEVIATION 11.87 • n=451 Participants
|
33.4 years
STANDARD_DEVIATION 8.44 • n=27 Participants
|
30.9 years
STANDARD_DEVIATION 7.28 • n=162 Participants
|
35.3 years
STANDARD_DEVIATION 9.99 • n=19729 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=14 Participants
|
5 Participants
n=34 Participants
|
5 Participants
n=69 Participants
|
5 Participants
n=140 Participants
|
4 Participants
n=451 Participants
|
3 Participants
n=27 Participants
|
4 Participants
n=162 Participants
|
29 Participants
n=19729 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=14 Participants
|
2 Participants
n=34 Participants
|
2 Participants
n=69 Participants
|
2 Participants
n=140 Participants
|
3 Participants
n=451 Participants
|
2 Participants
n=27 Participants
|
6 Participants
n=162 Participants
|
22 Participants
n=19729 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=162 Participants
|
0 Participants
n=19729 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=14 Participants
|
3 Participants
n=34 Participants
|
3 Participants
n=69 Participants
|
3 Participants
n=140 Participants
|
3 Participants
n=451 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=162 Participants
|
16 Participants
n=19729 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=162 Participants
|
0 Participants
n=19729 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=14 Participants
|
2 Participants
n=34 Participants
|
3 Participants
n=69 Participants
|
1 Participants
n=140 Participants
|
3 Participants
n=451 Participants
|
3 Participants
n=27 Participants
|
7 Participants
n=162 Participants
|
22 Participants
n=19729 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=14 Participants
|
2 Participants
n=34 Participants
|
1 Participants
n=69 Participants
|
3 Participants
n=140 Participants
|
1 Participants
n=451 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=162 Participants
|
13 Participants
n=19729 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=162 Participants
|
0 Participants
n=19729 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=34 Participants
|
0 Participants
n=69 Participants
|
0 Participants
n=140 Participants
|
0 Participants
n=451 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=162 Participants
|
0 Participants
n=19729 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=14 Participants
|
7 participants
n=34 Participants
|
7 participants
n=69 Participants
|
7 participants
n=140 Participants
|
7 participants
n=451 Participants
|
5 participants
n=27 Participants
|
10 participants
n=162 Participants
|
51 participants
n=19729 Participants
|
|
Height (cm)
|
170.9 cm
STANDARD_DEVIATION 8.22 • n=14 Participants
|
165.4 cm
STANDARD_DEVIATION 10.11 • n=34 Participants
|
165.3 cm
STANDARD_DEVIATION 11.91 • n=69 Participants
|
166.4 cm
STANDARD_DEVIATION 7.93 • n=140 Participants
|
167.1 cm
STANDARD_DEVIATION 13.04 • n=451 Participants
|
167.8 cm
STANDARD_DEVIATION 10.33 • n=27 Participants
|
174.9 cm
STANDARD_DEVIATION 11.82 • n=162 Participants
|
168.7 cm
STANDARD_DEVIATION 10.64 • n=19729 Participants
|
|
Weight (kg)
|
73.53 Kg
STANDARD_DEVIATION 15.378 • n=14 Participants
|
69.64 Kg
STANDARD_DEVIATION 11.563 • n=34 Participants
|
66.3 Kg
STANDARD_DEVIATION 16.236 • n=69 Participants
|
70.03 Kg
STANDARD_DEVIATION 11.517 • n=140 Participants
|
67.24 Kg
STANDARD_DEVIATION 12.699 • n=451 Participants
|
71.36 Kg
STANDARD_DEVIATION 4.225 • n=27 Participants
|
74.33 Kg
STANDARD_DEVIATION 10.624 • n=162 Participants
|
70.60 Kg
STANDARD_DEVIATION 12.097 • n=19729 Participants
|
|
Body Mass Index
|
25.10 kg/m2
STANDARD_DEVIATION 4.275 • n=14 Participants
|
25.39 kg/m2
STANDARD_DEVIATION 2.812 • n=34 Participants
|
23.96 kg/m2
STANDARD_DEVIATION 3.625 • n=69 Participants
|
24.86 kg/m2
STANDARD_DEVIATION 4.156 • n=140 Participants
|
24.00 kg/m2
STANDARD_DEVIATION 2.864 • n=451 Participants
|
25.52 kg/m2
STANDARD_DEVIATION 2.906 • n=27 Participants
|
24.52 kg/m2
STANDARD_DEVIATION 2.011 • n=162 Participants
|
24.67 kg/m2
STANDARD_DEVIATION 3.145 • n=19729 Participants
|
PRIMARY outcome
Timeframe: Baseline to day 112Population: Safety Population
The number adverse events (AEs), serious adverse events (SAEs), and drug related events following administration of VIS649. Safety will be assessed via AE severity per CTCAE v4.0
Outcome measures
| Measure |
VIS649 Cohort 4
n=3 Participants
A single dose (12 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Pooled Placebo
n=4 Participants
Single IV dose of placebo will be administered via IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 1
n=2 Participants
A single dose (0.5 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 2
n=3 Participants
A single dose (2.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 3
n=3 Participants
A single dose (6.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Placebo Cohort 5 + Vaccine
n=3 Participants
Single dose of placebo followed by single dose of vaccine
|
VIS649 Cohort 5 + Vaccine
n=4 Participants
Single dose of 6.0 mg/kg VIS649 followed by single dose of vaccine
|
|---|---|---|---|---|---|---|---|
|
Overall Summary of Treatment Emergent Adverse Events
Adverse Events
|
7 Event
|
8 Event
|
3 Event
|
7 Event
|
7 Event
|
6 Event
|
4 Event
|
|
Overall Summary of Treatment Emergent Adverse Events
Serious Adverse Events
|
0 Event
|
0 Event
|
0 Event
|
0 Event
|
0 Event
|
0 Event
|
0 Event
|
|
Overall Summary of Treatment Emergent Adverse Events
Severe severity
|
0 Event
|
0 Event
|
0 Event
|
1 Event
|
0 Event
|
0 Event
|
0 Event
|
|
Overall Summary of Treatment Emergent Adverse Events
Drug related events
|
1 Event
|
3 Event
|
2 Event
|
3 Event
|
3 Event
|
1 Event
|
0 Event
|
|
Overall Summary of Treatment Emergent Adverse Events
Mild severity
|
3 Event
|
4 Event
|
2 Event
|
2 Event
|
1 Event
|
3 Event
|
4 Event
|
|
Overall Summary of Treatment Emergent Adverse Events
Moderate severity
|
0 Event
|
0 Event
|
0 Event
|
0 Event
|
2 Event
|
0 Event
|
0 Event
|
SECONDARY outcome
Timeframe: 0, 1, 2, 8, and 24-hours post-dose, Day 3, 7, 14, 28, 42, 56, 70, and 112.Population: Pharmacokinetic Population (all randomized participants with at least 1 quantifiable VIS649 concentration).
The maximum serum concentration (Cmax) of VIS649 determined by an electrochemiluminescence (ECL) immunoassay and analyzed by standard non-compartmental pharmacokinetic methods. All participants
Outcome measures
| Measure |
VIS649 Cohort 4
n=10 Participants
A single dose (12 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Pooled Placebo
n=7 Participants
Single IV dose of placebo will be administered via IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 1
n=7 Participants
A single dose (0.5 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 2
n=7 Participants
A single dose (2.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 3
n=7 Participants
A single dose (6.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Placebo Cohort 5 + Vaccine
Single dose of placebo followed by single dose of vaccine
|
VIS649 Cohort 5 + Vaccine
Single dose of 6.0 mg/kg VIS649 followed by single dose of vaccine
|
|---|---|---|---|---|---|---|---|
|
Cmax: Maximum Serum VIS649 Concentration Determined Directly From the Concentration-time Profile. All Participants
|
130.700 μg/mL
Standard Deviation 20.150
|
12.600 μg/mL
Standard Deviation 2.222
|
48.600 μg/mL
Standard Deviation 11.660
|
135.900 μg/mL
Standard Deviation 20.380
|
282.600 μg/mL
Standard Deviation 48.440
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 1, 2, 8, and 24-hours post-dose, Day 3, 7, 14, 28, 42, 56, 70, and 112.Population: Pharmacokinetic Population (all randomized participants with at least 1 quantifiable VIS649 concentration).
The time to the maximum serum concentration (tmax) of VIS649 as determined by an electrochemiluminescence (ECL) immunoassay and analyzed by standard non-compartmental pharmacokinetic methods. All participants
Outcome measures
| Measure |
VIS649 Cohort 4
n=10 Participants
A single dose (12 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Pooled Placebo
n=7 Participants
Single IV dose of placebo will be administered via IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 1
n=7 Participants
A single dose (0.5 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 2
n=7 Participants
A single dose (2.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 3
n=7 Participants
A single dose (6.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Placebo Cohort 5 + Vaccine
Single dose of placebo followed by single dose of vaccine
|
VIS649 Cohort 5 + Vaccine
Single dose of 6.0 mg/kg VIS649 followed by single dose of vaccine
|
|---|---|---|---|---|---|---|---|
|
Tmax: Time to the Maximum Serum VIS649 Concentration Determined Directly From the Concentration-time Profile. All Participant
|
3.053 hours
Interval 1.14 to 25.11
|
1.136 hours
Interval 1.12 to 3.11
|
3.045 hours
Interval 1.15 to 3.09
|
3.038 hours
Interval 1.13 to 3.16
|
1.148 hours
Interval 1.11 to 9.11
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 1, 2, 8, and 24-hours post-dose, Day 3, 7, 14, 28, 42, 56, 70, and 112.Population: Pharmacokinetic Population (all randomized participants with at least 1 quantifiable VIS649 concentration) including all ethnicities.
Summary of the pharmacokinetic profiles of VIS649 exposure in serum for all participants. AUC0-112 presents the area under the concentration time curve from pre-dose (time 0) to the concentration on day 112. AUC0-last presents the area under the concentration time curve from pre-dose (time 0) to the last quantifiable concentration. AUC0-inf presents the area under the concentration time curve from pre-dose (time 0) extrapolated to infinite time.
Outcome measures
| Measure |
VIS649 Cohort 4
n=10 Participants
A single dose (12 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Pooled Placebo
n=7 Participants
Single IV dose of placebo will be administered via IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 1
n=7 Participants
A single dose (0.5 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 2
n=7 Participants
A single dose (2.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 3
n=7 Participants
A single dose (6.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Placebo Cohort 5 + Vaccine
Single dose of placebo followed by single dose of vaccine
|
VIS649 Cohort 5 + Vaccine
Single dose of 6.0 mg/kg VIS649 followed by single dose of vaccine
|
|---|---|---|---|---|---|---|---|
|
The Pharmacokinetic Exposure Profiles of VIS649 in Serum. All Participants
AUC 0-last
|
53630 h*μg/mL
Standard Deviation 18180
|
885.2 h*μg/mL
Standard Deviation 146.2
|
10510 h*μg/mL
Standard Deviation 2811
|
72760 h*μg/mL
Standard Deviation 19210
|
148900 h*μg/mL
Standard Deviation 17460
|
—
|
—
|
|
The Pharmacokinetic Exposure Profiles of VIS649 in Serum. All Participants
AUC 0-inf
|
57910 h*μg/mL
Standard Deviation 18390
|
1118 h*μg/mL
Standard Deviation 209.5
|
11670 h*μg/mL
Standard Deviation 3403
|
74380 h*μg/mL
Standard Deviation 18620
|
187400 h*μg/mL
Standard Deviation 35980
|
—
|
—
|
|
The Pharmacokinetic Exposure Profiles of VIS649 in Serum. All Participants
AUC 0-112 days
|
57900 h*μg/mL
Standard Deviation 18390
|
1118 h*μg/mL
Standard Deviation 209.4
|
11680 h*μg/mL
Standard Deviation 3402
|
74500 h*μg/mL
Standard Deviation 18570
|
176300 h*μg/mL
Standard Deviation 26100
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 1, 2, 8, and 24-hours post-dose, Day 3, 7, 14, 28, 42, 56, 70, and 112.Population: Pharmacokinetic Population (all randomized participants with at least 1 quantifiable VIS649 concentration).
The terminal elimination half life (t1/2) of VIS649 from the concentration-time profile as determined by an electrochemiluminescence (ECL) immunoassay and analyzed by standard non-compartmental pharmacokinetic methods.
Outcome measures
| Measure |
VIS649 Cohort 4
n=10 Participants
A single dose (12 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Pooled Placebo
n=7 Participants
Single IV dose of placebo will be administered via IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 1
n=7 Participants
A single dose (0.5 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 2
n=7 Participants
A single dose (2.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 3
n=7 Participants
A single dose (6.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Placebo Cohort 5 + Vaccine
Single dose of placebo followed by single dose of vaccine
|
VIS649 Cohort 5 + Vaccine
Single dose of 6.0 mg/kg VIS649 followed by single dose of vaccine
|
|---|---|---|---|---|---|---|---|
|
T 1/2 The Terminal Elimination Half Life of VIS649 in Serum Samples. All Participants
|
342.10 hours
Standard Deviation 91.62
|
60.72 hours
Standard Deviation 4.35
|
175.20 hours
Standard Deviation 38.40
|
230.90 hours
Standard Deviation 76.20
|
670 hours
Standard Deviation 179.80
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to day 112Population: Pharmacokinetic Population (all randomized participants with at least 1 quantifiable VIS649 concentration).
The clearance rate (CL) of VIS649 using the exposure calculated to infinity of VIS649 as determined by an electrochemiluminescence (ECL) immunoassay and analyzed by standard non-compartmental pharmacokinetic methods. All participants.
Outcome measures
| Measure |
VIS649 Cohort 4
n=10 Participants
A single dose (12 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Pooled Placebo
n=7 Participants
Single IV dose of placebo will be administered via IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 1
n=7 Participants
A single dose (0.5 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 2
n=7 Participants
A single dose (2.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 3
n=7 Participants
A single dose (6.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Placebo Cohort 5 + Vaccine
Single dose of placebo followed by single dose of vaccine
|
VIS649 Cohort 5 + Vaccine
Single dose of 6.0 mg/kg VIS649 followed by single dose of vaccine
|
|---|---|---|---|---|---|---|---|
|
CL: The Clearance of VIS649 in Serum Samples Calculated Using Exposure Extrapolated to Infinity by Dose.
|
8.724 mL/h
Standard Deviation 4.137
|
31.46 mL/h
Standard Deviation 4.544
|
11.70 mL/h
Standard Deviation 2.522
|
6.125 mL/h
Standard Deviation 2.263
|
4.508 mL/h
Standard Deviation 1.375
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to day 112Population: Pharmacokinetic Population (all randomized participants with at least 1 quantifiable VIS649 concentration).
The volume of distribution of VIS649 as determined by an electrochemiluminescence (ECL) immunoassay and analyzed by standard non-compartmental pharmacokinetic methods. All participants.
Outcome measures
| Measure |
VIS649 Cohort 4
n=10 Participants
A single dose (12 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Pooled Placebo
n=7 Participants
Single IV dose of placebo will be administered via IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 1
n=7 Participants
A single dose (0.5 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 2
n=7 Participants
A single dose (2.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 3
n=7 Participants
A single dose (6.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Placebo Cohort 5 + Vaccine
Single dose of placebo followed by single dose of vaccine
|
VIS649 Cohort 5 + Vaccine
Single dose of 6.0 mg/kg VIS649 followed by single dose of vaccine
|
|---|---|---|---|---|---|---|---|
|
Vd: The Volume of Distribution of VIS649 in Serum Samples. All Participants
|
3911 mL
Standard Deviation 828.4
|
2747 mL
Standard Deviation 351.6
|
2854 mL
Standard Deviation 323.5
|
2183 mL
Standard Deviation 1365
|
4122 mL
Standard Deviation 780.4
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 1, 2, 8, and 24-hours post-dose, Day 3, 7, 14, 28, 42, 56, 70, and 112.Population: Pharmacokinetic Population (all randomized participants with at least 1 quantifiable VIS649 concentration) of Japanese ethnicity.
The maximum serum concentration (Cmax) of VIS649 determined by an electrochemiluminescence (ECL) immunoassay and analyzed by standard non-compartmental pharmacokinetic methods. Japanese participants
Outcome measures
| Measure |
VIS649 Cohort 4
A single dose (12 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Pooled Placebo
n=3 Participants
Single IV dose of placebo will be administered via IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 1
n=3 Participants
A single dose (0.5 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 2
n=3 Participants
A single dose (2.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 3
n=3 Participants
A single dose (6.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Placebo Cohort 5 + Vaccine
Single dose of placebo followed by single dose of vaccine
|
VIS649 Cohort 5 + Vaccine
Single dose of 6.0 mg/kg VIS649 followed by single dose of vaccine
|
|---|---|---|---|---|---|---|---|
|
Cmax: Maximum Serum VIS649 Concentration Determined Directly From the Time Profile. Japanese Participants
|
—
|
11.83 μg/mL
Standard Deviation 1.172
|
40.13 μg/mL
Standard Deviation 4.302
|
133.0 μg/mL
Standard Deviation 12.12
|
249.0 μg/mL
Standard Deviation 47.84
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 1, 2, 8, and 24-hours post-dose, Day 3, 7, 14, 28, 42, 56, 70, and 112.Population: Pharmacokinetic Population (all randomized participants with at least 1 quantifiable VIS649 concentration) of Japanese ethnicity.
The time to the maximum serum concentration (tmax) of VIS649 as determined by an electrochemiluminescence (ECL) immunoassay and analyzed by standard non-compartmental pharmacokinetic methods. Japanese participants.
Outcome measures
| Measure |
VIS649 Cohort 4
A single dose (12 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Pooled Placebo
n=3 Participants
Single IV dose of placebo will be administered via IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 1
n=3 Participants
A single dose (0.5 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 2
n=3 Participants
A single dose (2.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 3
n=3 Participants
A single dose (6.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Placebo Cohort 5 + Vaccine
Single dose of placebo followed by single dose of vaccine
|
VIS649 Cohort 5 + Vaccine
Single dose of 6.0 mg/kg VIS649 followed by single dose of vaccine
|
|---|---|---|---|---|---|---|---|
|
Tmax: Time to the Maximum Serum VIS649 Concentration Determined Directly From the Concentration-time Profile. Japanese Participants
|
—
|
1.136 hours
Interval 1.13 to 3.05
|
3.045 hours
Interval 1.15 to 3.09
|
3.049 hours
Interval 1.14 to 3.16
|
3.064 hours
Interval 1.12 to 9.11
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 1, 2, 8, and 24-hours post-dose, Day 3, 7, 14, 28, 42, 56, 70, and 112.Population: Pharmacokinetic Population (all randomized participants with at least 1 quantifiable VIS649 concentration) Japanese participants.
AUC0-112 presents the area under the concentration time curve from pre-dose (time 0) to the concentration on day 112. AUC0-last presents the area under the concentration time curve from pre-dose (time 0) to the last quantifiable concentration. AUC0-inf presents the area under the concentration time curve from pre-dose (time 0) extrapolated to infinite time.
Outcome measures
| Measure |
VIS649 Cohort 4
A single dose (12 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Pooled Placebo
n=3 Participants
Single IV dose of placebo will be administered via IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 1
n=3 Participants
A single dose (0.5 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 2
n=3 Participants
A single dose (2.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 3
n=3 Participants
A single dose (6.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Placebo Cohort 5 + Vaccine
Single dose of placebo followed by single dose of vaccine
|
VIS649 Cohort 5 + Vaccine
Single dose of 6.0 mg/kg VIS649 followed by single dose of vaccine
|
|---|---|---|---|---|---|---|---|
|
The Pharmacokinetic Exposure Profiles of VIS649 in Serum. Japanese Participants
AUC 0-last
|
—
|
820.6 h*μg/mL
Standard Deviation 25.48
|
8824 h*μg/mL
Standard Deviation 216.3
|
85750 h*μg/mL
Standard Deviation 11220
|
150300 h*μg/mL
Standard Deviation 21630
|
—
|
—
|
|
The Pharmacokinetic Exposure Profiles of VIS649 in Serum. Japanese Participants
AUC 0-112 days
|
—
|
1039 h*μg/mL
Standard Deviation 56.05
|
9405 h*μg/mL
Standard Deviation 434.5
|
87210 h*μg/mL
Standard Deviation 11210
|
185200 h*μg/mL
Standard Deviation 32550
|
—
|
—
|
|
The Pharmacokinetic Exposure Profiles of VIS649 in Serum. Japanese Participants
AUC 0-inf
|
—
|
1039 h*μg/mL
Standard Deviation 56.01
|
9399 h*μg/mL
Standard Deviation 432.1
|
87170 h*μg/mL
Standard Deviation 11210
|
203500 h*μg/mL
Standard Deviation 47430
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 1, 2, 8, and 24-hours post-dose, Day 3, 7, 14, 28, 42, 56, 70, and 112.Population: Pharmacokinetic Population (all randomized participants with at least 1 quantifiable VIS649 concentration) Japanese participants.
The terminal elimination half life (t1/2) of VIS649 from the concentration-time profile as determined by an electrochemiluminescence (ECL) immunoassay and analyzed by standard non-compartmental pharmacokinetic methods.
Outcome measures
| Measure |
VIS649 Cohort 4
A single dose (12 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Pooled Placebo
n=3 Participants
Single IV dose of placebo will be administered via IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 1
n=3 Participants
A single dose (0.5 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 2
n=3 Participants
A single dose (2.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 3
n=3 Participants
A single dose (6.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Placebo Cohort 5 + Vaccine
Single dose of placebo followed by single dose of vaccine
|
VIS649 Cohort 5 + Vaccine
Single dose of 6.0 mg/kg VIS649 followed by single dose of vaccine
|
|---|---|---|---|---|---|---|---|
|
T1/2 The Terminal Elimination Half Life of VIS649 in Serum Samples. Japanese Participants
|
—
|
59.24 hours
Standard Deviation 3.623
|
158.8 hours
Standard Deviation 14.67
|
189.8 hours
Standard Deviation 12.65
|
778.4 hours
Standard Deviation 247.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to day 112.Population: Pharmacokinetic Population (all randomized participants with at least 1 quantifiable VIS649 concentration) of Japanese ethnicity.
The clearance rate (CL) of VIS649 using the exposure calculated to infinity of VIS649 as determined by an electrochemiluminescence (ECL) immunoassay and analyzed by standard non-compartmental pharmacokinetic methods.
Outcome measures
| Measure |
VIS649 Cohort 4
A single dose (12 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Pooled Placebo
n=3 Participants
Single IV dose of placebo will be administered via IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 1
n=3 Participants
A single dose (0.5 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 2
n=3 Participants
A single dose (2.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 3
n=3 Participants
A single dose (6.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Placebo Cohort 5 + Vaccine
Single dose of placebo followed by single dose of vaccine
|
VIS649 Cohort 5 + Vaccine
Single dose of 6.0 mg/kg VIS649 followed by single dose of vaccine
|
|---|---|---|---|---|---|---|---|
|
CL: The Clearance of VIS649 in Serum Samples Calculated Using Exposure Extrapolated to Infinity by Dose. Japanese Participants
|
—
|
28.58 mL/h
Standard Deviation 1.794
|
12.26 mL/h
Standard Deviation 0.7651
|
4.385 mL/h
Standard Deviation 1.242
|
3.618 mL/h
Standard Deviation 1.442
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to day 112.Population: Pharmacokinetic Population (all randomized participants with at least 1 quantifiable VIS649 concentration) of Japanese ethnicity.
The volume of distribution of VIS649 as determined by an electrochemiluminescence (ECL) immunoassay and analyzed by standard non-compartmental pharmacokinetic methods.
Outcome measures
| Measure |
VIS649 Cohort 4
A single dose (12 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Pooled Placebo
n=3 Participants
Single IV dose of placebo will be administered via IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 1
n=3 Participants
A single dose (0.5 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 2
n=3 Participants
A single dose (2.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 3
n=3 Participants
A single dose (6.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Placebo Cohort 5 + Vaccine
Single dose of placebo followed by single dose of vaccine
|
VIS649 Cohort 5 + Vaccine
Single dose of 6.0 mg/kg VIS649 followed by single dose of vaccine
|
|---|---|---|---|---|---|---|---|
|
Vd: The Volume of Distribution of VIS649 in Serum Samples. Japanese Participants
|
—
|
2441 mL
Standard Deviation 197.9
|
2816 mL
Standard Deviation 390.3
|
1197 mL
Standard Deviation 344.5
|
3772 mL
Standard Deviation 674.7
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 1, 2, 8, and 24-hours post-dose, Day 3, 7, 14, 28, 42, 56, 70, and 112.Population: Pharmacokinetic Population (all randomized participants with at least 1 quantifiable VIS649 concentration) of non-Japanese ethnicity.
The maximum serum concentration (Cmax) of VIS649 determined by an electrochemiluminescence (ECL) immunoassay and analyzed by standard non-compartmental pharmacokinetic methods.
Outcome measures
| Measure |
VIS649 Cohort 4
n=10 Participants
A single dose (12 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Pooled Placebo
n=4 Participants
Single IV dose of placebo will be administered via IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 1
n=4 Participants
A single dose (0.5 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 2
n=4 Participants
A single dose (2.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 3
n=4 Participants
A single dose (6.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Placebo Cohort 5 + Vaccine
Single dose of placebo followed by single dose of vaccine
|
VIS649 Cohort 5 + Vaccine
Single dose of 6.0 mg/kg VIS649 followed by single dose of vaccine
|
|---|---|---|---|---|---|---|---|
|
Cmax: Maximum Serum VIS649 Concentration Determined Directly From the Concentration-time Profile. Non-Japanese Participants
|
130.7 μg/mL
Standard Deviation 20.15
|
13.18 μg/mL
Standard Deviation 2.816
|
54.95 μg/mL
Standard Deviation 11.57
|
138.1 μg/mL
Standard Deviation 26.80
|
307.8 μg/mL
Standard Deviation 34.56
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 1, 2, 8, and 24-hours post-dose, Day 3, 7, 14, 28, 42, 56, 70, and 112.Population: Pharmacokinetic Population (all randomized participants with at least 1 quantifiable VIS649 concentration) of non-Japanese ethnicity.
The time to the maximum serum concentration (tmax) of VIS649 as determined by an electrochemiluminescence (ECL) immunoassay and analyzed by standard non-compartmental pharmacokinetic methods.
Outcome measures
| Measure |
VIS649 Cohort 4
n=10 Participants
A single dose (12 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Pooled Placebo
n=4 Participants
Single IV dose of placebo will be administered via IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 1
n=4 Participants
A single dose (0.5 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 2
n=4 Participants
A single dose (2.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 3
n=4 Participants
A single dose (6.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Placebo Cohort 5 + Vaccine
Single dose of placebo followed by single dose of vaccine
|
VIS649 Cohort 5 + Vaccine
Single dose of 6.0 mg/kg VIS649 followed by single dose of vaccine
|
|---|---|---|---|---|---|---|---|
|
Tmax: Time to the Maximum Serum VIS649 Concentration Determined Directly From the Concentration-time Profile. Non-Japanese Participants
|
3.053 hours
Interval 1.14 to 25.11
|
1.170 hours
Interval 1.12 to 3.11
|
2.253 hours
Interval 1.18 to 3.09
|
2.159 hours
Interval 1.13 to 3.06
|
1.142 hours
Interval 1.11 to 3.09
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 1, 2, 8, and 24-hours post-dose, Day 3, 7, 14, 28, 42, 56, 70, and 112.Population: Pharmacokinetic Population (all randomized participants with at least 1 quantifiable VIS649 concentration) non-Japanese participants.
Summary of the pharmacokinetic profiles of VIS649 exposure in serum for non-Japanese participants. AUC0-112 presents the area under the concentration time curve from pre-dose (time 0) to the concentration on day 112. AUC0-last presents the area under the concentration time curve from pre-dose (time 0) to the last quantifiable concentration. AUC0-inf presents the area under the concentration time curve from pre-dose (time 0) extrapolated to infinite time.
Outcome measures
| Measure |
VIS649 Cohort 4
n=10 Participants
A single dose (12 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Pooled Placebo
n=4 Participants
Single IV dose of placebo will be administered via IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 1
n=4 Participants
A single dose (0.5 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 2
n=4 Participants
A single dose (2.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 3
n=4 Participants
A single dose (6.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Placebo Cohort 5 + Vaccine
Single dose of placebo followed by single dose of vaccine
|
VIS649 Cohort 5 + Vaccine
Single dose of 6.0 mg/kg VIS649 followed by single dose of vaccine
|
|---|---|---|---|---|---|---|---|
|
The Pharmacokinetic Exposure Profiles of VIS649 in Serum. Non-Japanese Participants
AUC 0-112 days
|
57900 h*μg/mL
Standard Deviation 18390
|
1177 h*μg/mL
Standard Deviation 273.4
|
13380 h*μg/mL
Standard Deviation 3741
|
64960 h*μg/mL
Standard Deviation 17990
|
169700 h*μg/mL
Standard Deviation 22790
|
—
|
—
|
|
The Pharmacokinetic Exposure Profiles of VIS649 in Serum. Non-Japanese Participants
AUC 0-last
|
53630 h*μg/mL
Standard Deviation 18180
|
933.6 h*μg/mL
Standard Deviation 187.1
|
11780 h*μg/mL
Standard Deviation 3283
|
63020 h*μg/mL
Standard Deviation 18950
|
147900 h*μg/mL
Standard Deviation 17160
|
—
|
—
|
|
The Pharmacokinetic Exposure Profiles of VIS649 in Serum. Non-Japanese Participants
AUC 0-inf
|
57910 h*μg/mL
Standard Deviation 18390
|
1177 h*μg/mL
Standard Deviation 273.6
|
13380 h*μg/mL
Standard Deviation 3741
|
64790 h*μg/mL
Standard Deviation 17980
|
175300 h*μg/mL
Standard Deviation 25200
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 1, 2, 8, and 24-hours post-dose, Day 3, 7, 14, 28, 42, 56, 70, and 112.Population: Pharmacokinetic Population (all randomized participants with at least 1 quantifiable VIS649 concentration) non-Japanese participants.
The terminal elimination half life (t1/2) of VIS649 from the concentration-time profile as determined by an electrochemiluminescence (ECL) immunoassay and analyzed by standard non-compartmental pharmacokinetic methods. Non-Japanese participants.
Outcome measures
| Measure |
VIS649 Cohort 4
n=10 Participants
A single dose (12 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Pooled Placebo
n=4 Participants
Single IV dose of placebo will be administered via IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 1
n=4 Participants
A single dose (0.5 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 2
n=4 Participants
A single dose (2.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 3
n=4 Participants
A single dose (6.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Placebo Cohort 5 + Vaccine
Single dose of placebo followed by single dose of vaccine
|
VIS649 Cohort 5 + Vaccine
Single dose of 6.0 mg/kg VIS649 followed by single dose of vaccine
|
|---|---|---|---|---|---|---|---|
|
T1/2 The Terminal Elimination Half Life of VIS649 in Serum Samples. Non-Japanese Participants
|
342.1 hours
Standard Deviation 91.62
|
61.83 hours
Standard Deviation 5.017
|
187.6 hours
Standard Deviation 48.26
|
261.8 hours
Standard Deviation 92.45
|
588.8 hours
Standard Deviation 57.65
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to day 112.Population: Pharmacokinetic Population (all randomized participants with at least 1 quantifiable VIS649 concentration) of non-Japanese ethnicity.
The clearance rate (CL) of VIS649 using the exposure calculated to infinity of VIS649 as determined by an electrochemiluminescence (ECL) immunoassay and analyzed by standard non-compartmental pharmacokinetic methods.
Outcome measures
| Measure |
VIS649 Cohort 4
n=10 Participants
A single dose (12 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Pooled Placebo
n=4 Participants
Single IV dose of placebo will be administered via IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 1
n=4 Participants
A single dose (0.5 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 2
n=4 Participants
A single dose (2.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 3
n=4 Participants
A single dose (6.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Placebo Cohort 5 + Vaccine
Single dose of placebo followed by single dose of vaccine
|
VIS649 Cohort 5 + Vaccine
Single dose of 6.0 mg/kg VIS649 followed by single dose of vaccine
|
|---|---|---|---|---|---|---|---|
|
CL: The Clearance of VIS649 in Serum Samples Calculated Using Exposure Extrapolated to Infinity by Dose. Non-Japanese Participants
|
8.724 mL/h
Standard Deviation 4.137
|
33.63 mL/h
Standard Deviation 4.959
|
11.27 mL/h
Standard Deviation 3.431
|
7.430 mL/h
Standard Deviation 1.978
|
5.175 mL/h
Standard Deviation 1.004
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 to day 112.Population: Pharmacokinetic Population (all randomized participants with at least 1 quantifiable VIS649 concentration) of non-Japanese ethnicity.
The volume of distribution of VIS649 as determined by an electrochemiluminescence (ECL) immunoassay and analyzed by standard non-compartmental pharmacokinetic methods.
Outcome measures
| Measure |
VIS649 Cohort 4
n=10 Participants
A single dose (12 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Pooled Placebo
n=4 Participants
Single IV dose of placebo will be administered via IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 1
n=4 Participants
A single dose (0.5 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 2
n=4 Participants
A single dose (2.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 3
n=4 Participants
A single dose (6.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Placebo Cohort 5 + Vaccine
Single dose of placebo followed by single dose of vaccine
|
VIS649 Cohort 5 + Vaccine
Single dose of 6.0 mg/kg VIS649 followed by single dose of vaccine
|
|---|---|---|---|---|---|---|---|
|
Vd: The Volume of Distribution of VIS649 in Serum Samples. Non-Japanese Participants
|
3911 mL
Standard Deviation 828.4
|
2976 mL
Standard Deviation 241.0
|
2882 mL
Standard Deviation 324.3
|
2923 mL
Standard Deviation 1395
|
4384 mL
Standard Deviation 837
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline to Week 24Population: Pharmacodynamic population: the Safety Population subset with at least 1 pharmacodynamic parameter assessment post study drug dosing.
The effect of VIS649 treatment on total IgG levels in serum, weekly observations from baseline to Week 24
Outcome measures
| Measure |
VIS649 Cohort 4
n=7 Participants
A single dose (12 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Pooled Placebo
n=8 Participants
Single IV dose of placebo will be administered via IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 1
n=7 Participants
A single dose (0.5 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 2
n=7 Participants
A single dose (2.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 3
n=7 Participants
A single dose (6.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Placebo Cohort 5 + Vaccine
n=5 Participants
Single dose of placebo followed by single dose of vaccine
|
VIS649 Cohort 5 + Vaccine
n=10 Participants
Single dose of 6.0 mg/kg VIS649 followed by single dose of vaccine
|
|---|---|---|---|---|---|---|---|
|
Pharmacodynamic Effect of VIS649 on Total Immunoglobulin G Species. All Participants
Week 6
|
850.0 mg/dL
Standard Deviation 191.40
|
1185.5 mg/dL
Standard Deviation 295.65
|
1105.0 mg/dL
Standard Deviation 285.27
|
990.0 mg/dL
Standard Deviation 216.58
|
1001.0 mg/dL
Standard Deviation 212.64
|
1111.0 mg/dL
Standard Deviation 202.60
|
971.0 mg/dL
Standard Deviation 194.19
|
|
Pharmacodynamic Effect of VIS649 on Total Immunoglobulin G Species. All Participants
Week 8
|
951.5 mg/dL
Standard Deviation 222.49
|
1199.5 mg/dL
Standard Deviation 311.20
|
1022.0 mg/dL
Standard Deviation 287.47
|
1022.5 mg/dL
Standard Deviation 220.65
|
974.0 mg/dL
Standard Deviation 174.83
|
1117.0 mg/dL
Standard Deviation 223.8
|
953.0 mg/dL
Standard Deviation 192.19
|
|
Pharmacodynamic Effect of VIS649 on Total Immunoglobulin G Species. All Participants
Week 10
|
841.0 mg/dL
Standard Deviation 196.81
|
1266.0 mg/dL
Standard Deviation 301.04
|
1035.0 mg/dL
Standard Deviation 333.11
|
985.0 mg/dL
Standard Deviation 234.14
|
1006.0 mg/dL
Standard Deviation 223.84
|
1037.0 mg/dL
Standard Deviation 196.39
|
845.0 mg/dL
Standard Deviation 211.71
|
|
Pharmacodynamic Effect of VIS649 on Total Immunoglobulin G Species. All Participants
Week 14
|
862.0 mg/dL
Standard Deviation 180.07
|
1180.0 mg/dL
Standard Deviation 282.87
|
1038.0 mg/dL
Standard Deviation 278.83
|
930.0 mg/dL
Standard Deviation 268.00
|
1071.5 mg/dL
Standard Deviation 160.55
|
—
|
—
|
|
Pharmacodynamic Effect of VIS649 on Total Immunoglobulin G Species. All Participants
Week 16
|
876.0 mg/dL
Standard Deviation 220.38
|
1147.5 mg/dL
Standard Deviation 278.04
|
1072.0 mg/dL
Standard Deviation 242.20
|
934.0 mg/dL
Standard Deviation 356.27
|
1104.0 mg/dL
Standard Deviation 233.23
|
1198.0 mg/dL
Standard Deviation 156.10
|
1049.0 mg/dL
Standard Deviation 261.94
|
|
Pharmacodynamic Effect of VIS649 on Total Immunoglobulin G Species. All Participants
Week 24
|
917.5 mg/dL
Standard Deviation 91.00
|
1250.5 mg/dL
Standard Deviation 312.89
|
—
|
—
|
1075.0 mg/dL
Standard Deviation 260.55
|
—
|
—
|
|
Pharmacodynamic Effect of VIS649 on Total Immunoglobulin G Species. All Participants
Baseline
|
1125.0 mg/dL
Standard Deviation 262.83
|
1138.0 mg/dL
Standard Deviation 288.08
|
1057 mg/dL
Standard Deviation 276.8
|
1243 mg/dL
Standard Deviation 293.55
|
1239.0 mg/dL
Standard Deviation 269.73
|
1080.0 mg/dL
Standard Deviation 225.92
|
1143.0 mg/dL
Standard Deviation 213.59
|
|
Pharmacodynamic Effect of VIS649 on Total Immunoglobulin G Species. All Participants
Week 1
|
1174.0 mg/dL
Standard Deviation 298.25
|
1152.0 mg/dL
Standard Deviation 323.58
|
1028.0 mg/dL
Standard Deviation 257.12
|
1140.0 mg/dL
Standard Deviation 212.10
|
1142.0 mg/dL
Standard Deviation 246.84
|
1098.0 mg/dL
Standard Deviation 225.06
|
1092.5 mg/dL
Standard Deviation 263.15
|
|
Pharmacodynamic Effect of VIS649 on Total Immunoglobulin G Species. All Participants
Week 2
|
1038.0 mg/dL
Standard Deviation 240.46
|
1150.5 mg/dL
Standard Deviation 280.89
|
987.0 mg/dL
Standard Deviation 271.89
|
1120.0 mg/dL
Standard Deviation 220.63
|
1108.0 mg/dL
Standard Deviation 196.16
|
1117.0 mg/dL
Standard Deviation 201.08
|
1053.5 mg/dL
Standard Deviation 216.66
|
|
Pharmacodynamic Effect of VIS649 on Total Immunoglobulin G Species. All Participants
Week 3
|
999.0 mg/dL
Standard Deviation 212.58
|
1174.0 mg/dL
Standard Deviation 293.55
|
946.0 mg/dL
Standard Deviation 242.33
|
1077.0 mg/dL
Standard Deviation 214.35
|
1076 mg/dL
Standard Deviation 214.49
|
1063.0 mg/dL
Standard Deviation 202.43
|
966.5 mg/dL
Standard Deviation 235.63
|
|
Pharmacodynamic Effect of VIS649 on Total Immunoglobulin G Species. All Participants
Week 4
|
1034 mg/dL
Standard Deviation 221.08
|
1184.0 mg/dL
Standard Deviation 304.93
|
1122.0 mg/dL
Standard Deviation 264.19
|
1038.0 mg/dL
Standard Deviation 218.35
|
1053.0 mg/dL
Standard Deviation 196.39
|
1077.0 mg/dL
Standard Deviation 186.74
|
1050.0 mg/dL
Standard Deviation 204.29
|
|
Pharmacodynamic Effect of VIS649 on Total Immunoglobulin G Species. All Participants
Week 5
|
980.0 mg/dL
Standard Deviation 184.59
|
1143.5 mg/dL
Standard Deviation 237.34
|
994.0 mg/dL
Standard Deviation 276.89
|
965.0 mg/dL
Standard Deviation 193.19
|
1005.0 mg/dL
Standard Deviation 216.24
|
1094.0 mg/dL
Standard Deviation 180.03
|
962.0 mg/dL
Standard Deviation 197.14
|
|
Pharmacodynamic Effect of VIS649 on Total Immunoglobulin G Species. All Participants
Week 7
|
929.0 mg/dL
Standard Deviation 184.67
|
1195.0 mg/dL
Standard Deviation 296.0
|
950.5 mg/dL
Standard Deviation 320.91
|
1005.0 mg/dL
Standard Deviation 236.55
|
948.0 mg/dL
Standard Deviation 195.02
|
—
|
—
|
|
Pharmacodynamic Effect of VIS649 on Total Immunoglobulin G Species. All Participants
Week 12
|
718.0 mg/dL
Standard Deviation 185.80
|
1215.0 mg/dL
Standard Deviation 282.42
|
992.0 mg/dL
Standard Deviation 287.94
|
1036.0 mg/dL
Standard Deviation 238.29
|
1027.0 mg/dL
Standard Deviation 168.63
|
1101.0 mg/dL
Standard Deviation 205.66
|
970.0 mg/dL
Standard Deviation 256.28
|
|
Pharmacodynamic Effect of VIS649 on Total Immunoglobulin G Species. All Participants
Week 20
|
1009.0 mg/dL
Standard Deviation 243.52
|
1269.0 mg/dL
Standard Deviation 279.38
|
—
|
—
|
1089.0 mg/dL
Standard Deviation 260.55
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline to Week 24Population: Pharmacodynamic population: the Safety Population subset with at least 1 pharmacodynamic parameter assessment post study drug dosing.
The effect of VIS649 treatment on total IgA levels in serum, weekly observations from Baseline to Week 24
Outcome measures
| Measure |
VIS649 Cohort 4
n=7 Participants
A single dose (12 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Pooled Placebo
n=8 Participants
Single IV dose of placebo will be administered via IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 1
n=7 Participants
A single dose (0.5 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 2
n=7 Participants
A single dose (2.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 3
n=7 Participants
A single dose (6.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Placebo Cohort 5 + Vaccine
n=5 Participants
Single dose of placebo followed by single dose of vaccine
|
VIS649 Cohort 5 + Vaccine
n=10 Participants
Single dose of 6.0 mg/kg VIS649 followed by single dose of vaccine
|
|---|---|---|---|---|---|---|---|
|
Pharmacodynamic Effect of VIS649 on Total Immunoglobulin A Species. All Participants
Baseline
|
243.0 mg/dL
Standard Deviation 96.48
|
217.0 mg/dL
Standard Deviation 70.44
|
202.0 mg/dL
Standard Deviation 71.69
|
213.0 mg/dL
Standard Deviation 82.89
|
233.0 mg/dL
Standard Deviation 136.30
|
202.0 mg/dL
Standard Deviation 77.00
|
222.5 mg/dL
Standard Deviation 65.16
|
|
Pharmacodynamic Effect of VIS649 on Total Immunoglobulin A Species. All Participants
Week 1
|
214.0 mg/dL
Standard Deviation 100.42
|
225.0 mg/dL
Standard Deviation 68.74
|
165.0 mg/dL
Standard Deviation 64.10
|
223.0 mg/dL
Standard Deviation 64.03
|
209.0 mg/dL
Standard Deviation 120.23
|
198.0 mg/dL
Standard Deviation 84.45
|
205.5 mg/dL
Standard Deviation 57.03
|
|
Pharmacodynamic Effect of VIS649 on Total Immunoglobulin A Species. All Participants
Week 3
|
155.0 mg/dL
Standard Deviation 74.91
|
217.0 mg/dL
Standard Deviation 73.17
|
147.0 mg/dL
Standard Deviation 54.07
|
158.0 mg/dL
Standard Deviation 49.15
|
163.0 mg/dL
Standard Deviation 103.95
|
193.0 mg/dL
Standard Deviation 84.93
|
155.5 mg/dL
Standard Deviation 41.48
|
|
Pharmacodynamic Effect of VIS649 on Total Immunoglobulin A Species. All Participants
Week 4
|
146.0 mg/dL
Standard Deviation 73.05
|
227.0 mg/dL
Standard Deviation 76.14
|
169.0 mg/dL
Standard Deviation 75.99
|
134.0 mg/dL
Standard Deviation 48.87
|
152.0 mg/dL
Standard Deviation 87.08
|
197.0 mg/dL
Standard Deviation 81.96
|
150.0 mg/dL
Standard Deviation 42.75
|
|
Pharmacodynamic Effect of VIS649 on Total Immunoglobulin A Species. All Participants
Week 5
|
128.0 mg/dL
Standard Deviation 60.93
|
208.5 mg/dL
Standard Deviation 71.81
|
164.0 mg/dL
Standard Deviation 64.44
|
133.0 mg/dL
Standard Deviation 43.46
|
142.0 mg/dL
Standard Deviation 87.7
|
194.0 mg/dL
Standard Deviation 87.73
|
137.0 mg/dL
Standard Deviation 38.30
|
|
Pharmacodynamic Effect of VIS649 on Total Immunoglobulin A Species. All Participants
Week 6
|
116.0 mg/dL
Standard Deviation 66.61
|
217.5 mg/dL
Standard Deviation 71.98
|
167.0 mg/dL
Standard Deviation 67.82
|
140.0 mg/dL
Standard Deviation 51.43
|
134.0 mg/dL
Standard Deviation 76.69
|
207.0 mg/dL
Standard Deviation 90.44
|
129.0 mg/dL
Standard Deviation 37.00
|
|
Pharmacodynamic Effect of VIS649 on Total Immunoglobulin A Species. All Participants
Week 7
|
110.5 mg/dL
Standard Deviation 68.99
|
229.0 mg/dL
Standard Deviation 68.86
|
152.5 mg/dL
Standard Deviation 71.68
|
148.0 mg/dL
Standard Deviation 53.76
|
113.0 mg/dL
Standard Deviation 74.53
|
—
|
—
|
|
Pharmacodynamic Effect of VIS649 on Total Immunoglobulin A Species. All Participants
Week 8
|
111.0 mg/dL
Standard Deviation 66.42
|
217.0 mg/dL
Standard Deviation 68.26
|
159.5 mg/dL
Standard Deviation 74.21
|
148.5 mg/dL
Standard Deviation 59.02
|
109.0 mg/dL
Standard Deviation 68.40
|
210.0 mg/dL
Standard Deviation 92.31
|
122.0 mg/dL
Standard Deviation 35.26
|
|
Pharmacodynamic Effect of VIS649 on Total Immunoglobulin A Species. All Participants
Week 12
|
87.0 mg/dL
Standard Deviation 59.27
|
227.5 mg/dL
Standard Deviation 74.44
|
169.0 mg/dL
Standard Deviation 65.26
|
171.0 mg/dL
Standard Deviation 59.46
|
179.0 mg/dL
Standard Deviation 107.20
|
192.0 mg/dL
Standard Deviation 85.87
|
144.0 mg/dL
Standard Deviation 54.34
|
|
Pharmacodynamic Effect of VIS649 on Total Immunoglobulin A Species. All Participants
Week 14
|
109.0 mg/dL
Standard Deviation 56.66
|
232.0 mg/dL
Standard Deviation 69.85
|
182.0 mg/dL
Standard Deviation 70.26
|
164.0 mg/dL
Standard Deviation 63.82
|
195.5 mg/dL
Standard Deviation 105.85
|
—
|
—
|
|
Pharmacodynamic Effect of VIS649 on Total Immunoglobulin A Species. All Participants
Week 16
|
124.0 mg/dL
Standard Deviation 71.96
|
220.0 mg/dL
Standard Deviation 70.88
|
179.0 mg/dL
Standard Deviation 69.35
|
165.0 mg/dL
Standard Deviation 89.38
|
158.0 mg/dL
Standard Deviation 116.54
|
192.0 mg/dL
Standard Deviation 85.98
|
169.0 mg/dL
Standard Deviation 52.57
|
|
Pharmacodynamic Effect of VIS649 on Total Immunoglobulin A Species. All Participants
Week 20
|
153.0 mg/dL
Standard Deviation 67.43
|
243.5 mg/dL
Standard Deviation 90.16
|
—
|
—
|
172.0 mg/dL
Standard Deviation 117.30
|
—
|
—
|
|
Pharmacodynamic Effect of VIS649 on Total Immunoglobulin A Species. All Participants
Week 24
|
153.5 mg/dL
Standard Deviation 83.43
|
239.0 mg/dL
Standard Deviation 94.36
|
—
|
—
|
164.0 mg/dL
Standard Deviation 123.92
|
—
|
—
|
|
Pharmacodynamic Effect of VIS649 on Total Immunoglobulin A Species. All Participants
Week 2
|
174.0 mg/dL
Standard Deviation 82.09
|
222.5 mg/dL
Standard Deviation 74.97
|
151.0 mg/dL
Standard Deviation 60.23
|
168.0 mg/dL
Standard Deviation 52.76
|
187.0 mg/dL
Standard Deviation 111.5
|
205.0 mg/dL
Standard Deviation 83.70
|
179.0 mg/dL
Standard Deviation 48.79
|
|
Pharmacodynamic Effect of VIS649 on Total Immunoglobulin A Species. All Participants
Week 10
|
105.0 mg/dL
Standard Deviation 61.87
|
215.5 mg/dL
Standard Deviation 67.79
|
161.0 mg/dL
Standard Deviation 59.74
|
171.0 mg/dL
Standard Deviation 60.80
|
123.0 mg/dL
Standard Deviation 89.55
|
207.0 mg/dL
Standard Deviation 83.97
|
127.0 mg/dL
Standard Deviation 46.87
|
SECONDARY outcome
Timeframe: From baseline to Week 24Population: Pharmacodynamic population: the Safety Population subset with at least 1 pharmacodynamic parameter assessment post study drug dosing.
The effect of VIS649 treatment on total IgM levels in serum, weekly observations from Baseline to Week 24
Outcome measures
| Measure |
VIS649 Cohort 4
n=7 Participants
A single dose (12 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Pooled Placebo
n=8 Participants
Single IV dose of placebo will be administered via IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 1
n=7 Participants
A single dose (0.5 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 2
n=7 Participants
A single dose (2.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 3
n=7 Participants
A single dose (6.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Placebo Cohort 5 + Vaccine
n=5 Participants
Single dose of placebo followed by single dose of vaccine
|
VIS649 Cohort 5 + Vaccine
n=10 Participants
Single dose of 6.0 mg/kg VIS649 followed by single dose of vaccine
|
|---|---|---|---|---|---|---|---|
|
Pharmacodynamic Effect of VIS649 on Total Immunoglobulin M Species. All Participants
Baseline
|
133.0 mg/dL
Standard Deviation 31.67
|
105.0 mg/dL
Standard Deviation 43.75
|
116.0 mg/dL
Standard Deviation 42.77
|
93.0 mg/dL
Standard Deviation 61.79
|
108.0 mg/dL
Standard Deviation 49.11
|
85.0 mg/dL
Standard Deviation 35.75
|
132.0 mg/dL
Standard Deviation 34.80
|
|
Pharmacodynamic Effect of VIS649 on Total Immunoglobulin M Species. All Participants
Week 1
|
128.0 mg/dL
Standard Deviation 28.80
|
108.0 mg/dL
Standard Deviation 38.78
|
117.0 mg/dL
Standard Deviation 39.91
|
70.0 mg/dL
Standard Deviation 46.31
|
100.0 mg/dL
Standard Deviation 46.15
|
85.0 mg/dL
Standard Deviation 36.02
|
102.5 mg/dL
Standard Deviation 31.82
|
|
Pharmacodynamic Effect of VIS649 on Total Immunoglobulin M Species. All Participants
Week 2
|
94.0 mg/dL
Standard Deviation 29.89
|
109.5 mg/dL
Standard Deviation 42.39
|
91.0 mg/dL
Standard Deviation 39.04
|
58.0 mg/dL
Standard Deviation 38.17
|
88.0 mg/dL
Standard Deviation 43.68
|
87.0 mg/dL
Standard Deviation 30.86
|
87.0 mg/dL
Standard Deviation 25.15
|
|
Pharmacodynamic Effect of VIS649 on Total Immunoglobulin M Species. All Participants
Week 3
|
80.0 mg/dL
Standard Deviation 26.13
|
105.0 mg/dL
Standard Deviation 39.49
|
85.0 mg/dL
Standard Deviation 34.49
|
52.0 mg/dL
Standard Deviation 35.40
|
71.0 mg/dL
Standard Deviation 38.17
|
86.0 mg/dL
Standard Deviation 38.91
|
73.5 mg/dL
Standard Deviation 24.02
|
|
Pharmacodynamic Effect of VIS649 on Total Immunoglobulin M Species. All Participants
Week 4
|
75.0 mg/dL
Standard Deviation 25.32
|
107.5 mg/dL
Standard Deviation 43.13
|
84.0 mg/dL
Standard Deviation 40.45
|
46.0 mg/dL
Standard Deviation 31.08
|
58.0 mg/dL
Standard Deviation 34.95
|
81.0 mg/dL
Standard Deviation 35.91
|
68.0 mg/dL
Standard Deviation 20.35
|
|
Pharmacodynamic Effect of VIS649 on Total Immunoglobulin M Species. All Participants
Week 5
|
60.0 mg/dL
Standard Deviation 19.85
|
106.0 mg/dL
Standard Deviation 39.41
|
83.0 mg/dL
Standard Deviation 34.54
|
40.5 mg/dL
Standard Deviation 23.01
|
49.0 mg/dL
Standard Deviation 32.13
|
84.0 mg/dL
Standard Deviation 35.50
|
54.0 mg/dL
Standard Deviation 15.41
|
|
Pharmacodynamic Effect of VIS649 on Total Immunoglobulin M Species. All Participants
Week 6
|
57.0 mg/dL
Standard Deviation 21.07
|
106.5 mg/dL
Standard Deviation 42.10
|
92.0 mg/dL
Standard Deviation 37.21
|
46.0 mg/dL
Standard Deviation 30.33
|
49 mg/dL
Standard Deviation 30.35
|
90 mg/dL
Standard Deviation 35.22
|
48.0 mg/dL
Standard Deviation 13.30
|
|
Pharmacodynamic Effect of VIS649 on Total Immunoglobulin M Species. All Participants
Week 8
|
46.0 mg/dL
Standard Deviation 19.31
|
110.5 mg/dL
Standard Deviation 40.73
|
89.5 mg/dL
Standard Deviation 37.91
|
43.0 mg/dL
Standard Deviation 26.77
|
46.0 mg/dL
Standard Deviation 23.80
|
89.0 mg/dL
Standard Deviation 33.93
|
42.0 mg/dL
Standard Deviation 11.07
|
|
Pharmacodynamic Effect of VIS649 on Total Immunoglobulin M Species. All Participants
Week 10
|
44.0 mg/dL
Standard Deviation 18.09
|
104.5 mg/dL
Standard Deviation 40.87
|
106.0 mg/dL
Standard Deviation 40.44
|
53.0 mg/dL
Standard Deviation 29.95
|
49.0 mg/dL
Standard Deviation 25.15
|
80.0 mg/dL
Standard Deviation 32.38
|
49.0 mg/dL
Standard Deviation 19.53
|
|
Pharmacodynamic Effect of VIS649 on Total Immunoglobulin M Species. All Participants
Week 12
|
35.0 mg/dL
Standard Deviation 20.30
|
113.0 mg/dL
Standard Deviation 41.39
|
106.0 mg/dL
Standard Deviation 37.89
|
54.0 mg/dL
Standard Deviation 36.41
|
73.5 mg/dL
Standard Deviation 26.46
|
93.0 mg/dL
Standard Deviation 41.37
|
63.0 mg/dL
Standard Deviation 25.09
|
|
Pharmacodynamic Effect of VIS649 on Total Immunoglobulin M Species. All Participants
Week 7
|
51.5 mg/dL
Standard Deviation 18.5
|
109.5 mg/dL
Standard Deviation 44.41
|
86.5 mg/dL
Standard Deviation 35.07
|
48.0 mg/dL
Standard Deviation 31.14
|
43.0 mg/dL
Standard Deviation 23.88
|
—
|
—
|
|
Pharmacodynamic Effect of VIS649 on Total Immunoglobulin M Species. All Participants
Week 14
|
44.0 mg/dL
Standard Deviation 15.14
|
113.0 mg/dL
Standard Deviation 40.09
|
114.0 mg/dL
Standard Deviation 41.32
|
55.0 mg/dL
Standard Deviation 33.05
|
82.5 mg/dL
Standard Deviation 30.31
|
—
|
—
|
|
Pharmacodynamic Effect of VIS649 on Total Immunoglobulin M Species. All Participants
Week 16
|
55.0 mg/dL
Standard Deviation 24.08
|
107.0 mg/dL
Standard Deviation 40.51
|
127.0 mg/dL
Standard Deviation 40.51
|
60.0 mg/dL
Standard Deviation 30.70
|
78.0 mg/dL
Standard Deviation 39.52
|
93.0 mg/dL
Standard Deviation 31.11
|
87.0 mg/dL
Standard Deviation 30.55
|
|
Pharmacodynamic Effect of VIS649 on Total Immunoglobulin M Species. All Participants
Week 20
|
69.0 mg/dL
Standard Deviation 23.84
|
80.0 mg/dL
Standard Deviation 42.54
|
—
|
—
|
90.0 mg/dL
Standard Deviation 38.11
|
—
|
—
|
|
Pharmacodynamic Effect of VIS649 on Total Immunoglobulin M Species. All Participants
Week 24
|
74.5 mg/dL
Standard Deviation 21.08
|
89.0 mg/dL
Standard Deviation 33.56
|
—
|
—
|
89.0 mg/dL
Standard Deviation 40.15
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline to Week 24Population: Pharmacodynamic population: the Safety Population subset with at least 1 pharmacodynamic parameter assessment post study drug dosing.
The effect of VIS649 treatment on the population of circulating CD16 +CD56 (Natural killer) cells in serum for all participants in cohorts 1-4.
Outcome measures
| Measure |
VIS649 Cohort 4
n=7 Participants
A single dose (12 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Pooled Placebo
n=8 Participants
Single IV dose of placebo will be administered via IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 1
n=7 Participants
A single dose (0.5 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 2
n=7 Participants
A single dose (2.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 3
n=7 Participants
A single dose (6.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Placebo Cohort 5 + Vaccine
Single dose of placebo followed by single dose of vaccine
|
VIS649 Cohort 5 + Vaccine
Single dose of 6.0 mg/kg VIS649 followed by single dose of vaccine
|
|---|---|---|---|---|---|---|---|
|
Pharmacodynamic Effect of VIS649 on Circulating CD16 +CD56 (Natural Killer) Cells for All Participants in Cohorts 1-4
Week 24
|
270.0 cells/mcl
Standard Deviation 142.83
|
195.0 cells/mcl
Standard Deviation 173.776
|
—
|
—
|
135.0 cells/mcl
Standard Deviation 41.35
|
—
|
—
|
|
Pharmacodynamic Effect of VIS649 on Circulating CD16 +CD56 (Natural Killer) Cells for All Participants in Cohorts 1-4
Baseline
|
142.0 cells/mcl
Standard Deviation 48.32
|
122.0 cells/mcl
Standard Deviation 156.14
|
136.0 cells/mcl
Standard Deviation 38.34
|
174.0 cells/mcl
Standard Deviation 88.43
|
107.0 cells/mcl
Standard Deviation 40.82
|
—
|
—
|
|
Pharmacodynamic Effect of VIS649 on Circulating CD16 +CD56 (Natural Killer) Cells for All Participants in Cohorts 1-4
Week 4
|
181.0 cells/mcl
Standard Deviation 82.05
|
142.5 cells/mcl
Standard Deviation 136.42
|
103.0 cells/mcl
Standard Deviation 46.6
|
144.0 cells/mcl
Standard Deviation 46.13
|
143.0 cells/mcl
Standard Deviation 45.80
|
—
|
—
|
|
Pharmacodynamic Effect of VIS649 on Circulating CD16 +CD56 (Natural Killer) Cells for All Participants in Cohorts 1-4
Week 16
|
153.0 cells/mcl
Standard Deviation 54.99
|
130.0 cells/mcl
Standard Deviation 30.41
|
150.0 cells/mcl
Standard Deviation 34.55
|
226.0 cells/mcl
Standard Deviation 90.19
|
138.0 cells/mcl
Standard Deviation 49.69
|
—
|
—
|
|
Pharmacodynamic Effect of VIS649 on Circulating CD16 +CD56 (Natural Killer) Cells for All Participants in Cohorts 1-4
Week 20
|
189.0 cells/mcl
Standard Deviation 120.94
|
204.0 cells/mcl
Standard Deviation 201.87
|
—
|
—
|
181.0 cells/mcl
Standard Deviation 58.45
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline to Week 24Population: Pharmacodynamic population: the Safety Population subset with at least 1 pharmacodynamic parameter assessment post study drug dosing.
The effect of VIS649 treatment on the population of circulating CD19 (B Cells) in serum for all participants in cohorts 1-4.
Outcome measures
| Measure |
VIS649 Cohort 4
n=7 Participants
A single dose (12 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Pooled Placebo
n=8 Participants
Single IV dose of placebo will be administered via IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 1
n=7 Participants
A single dose (0.5 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 2
n=7 Participants
A single dose (2.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 3
n=7 Participants
A single dose (6.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Placebo Cohort 5 + Vaccine
Single dose of placebo followed by single dose of vaccine
|
VIS649 Cohort 5 + Vaccine
Single dose of 6.0 mg/kg VIS649 followed by single dose of vaccine
|
|---|---|---|---|---|---|---|---|
|
Pharmacodynamic Effect of VIS649 on Circulating CD19 (B Cells) for All Participants in Cohorts 1-4
Week 16
|
167.0 cells/uL
Standard Deviation 55.86
|
166.0 cells/uL
Standard Deviation 93.65
|
226.0 cells/uL
Standard Deviation 51.84
|
209.0 cells/uL
Standard Deviation 98.99
|
359.0 cells/uL
Standard Deviation 113.22
|
—
|
—
|
|
Pharmacodynamic Effect of VIS649 on Circulating CD19 (B Cells) for All Participants in Cohorts 1-4
Week 24
|
239.0 cells/uL
Standard Deviation 76.41
|
270.5 cells/uL
Standard Deviation 76.49
|
—
|
—
|
267.0 cells/uL
Standard Deviation 65.38
|
—
|
—
|
|
Pharmacodynamic Effect of VIS649 on Circulating CD19 (B Cells) for All Participants in Cohorts 1-4
Baseline
|
179.0 cells/uL
Standard Deviation 49.44
|
165 cells/uL
Standard Deviation 128.25
|
193.0 cells/uL
Standard Deviation 23.72
|
244.0 cells/uL
Standard Deviation 89.67
|
268.0 cells/uL
Standard Deviation 79.96
|
—
|
—
|
|
Pharmacodynamic Effect of VIS649 on Circulating CD19 (B Cells) for All Participants in Cohorts 1-4
Week 4
|
202.0 cells/uL
Standard Deviation 67.12
|
187.0 cells/uL
Standard Deviation 73.92
|
206.0 cells/uL
Standard Deviation 34.69
|
204.0 cells/uL
Standard Deviation 78.55
|
294.0 cells/uL
Standard Deviation 129.97
|
—
|
—
|
|
Pharmacodynamic Effect of VIS649 on Circulating CD19 (B Cells) for All Participants in Cohorts 1-4
Week 20
|
190.0 cells/uL
Standard Deviation 72.04
|
277.5 cells/uL
Standard Deviation 70.72
|
—
|
—
|
320.0 cells/uL
Standard Deviation 146.34
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline to Week 24Population: Pharmacodynamic population: the Safety Population subset with at least 1 pharmacodynamic parameter assessment post study drug dosing.
The effect of VIS649 treatment on the population of circulating CD4 T cells in serum for all participants in cohorts 1-4.
Outcome measures
| Measure |
VIS649 Cohort 4
n=7 Participants
A single dose (12 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Pooled Placebo
n=8 Participants
Single IV dose of placebo will be administered via IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 1
n=7 Participants
A single dose (0.5 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 2
n=7 Participants
A single dose (2.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 3
n=7 Participants
A single dose (6.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Placebo Cohort 5 + Vaccine
Single dose of placebo followed by single dose of vaccine
|
VIS649 Cohort 5 + Vaccine
Single dose of 6.0 mg/kg VIS649 followed by single dose of vaccine
|
|---|---|---|---|---|---|---|---|
|
Pharmacodynamic Effect of VIS649 on Circulating CD4 T Cells for All Participants in Cohorts 1-4
Baseline
|
698.0 cells/uL
Standard Deviation 166.09
|
679.0 cells/uL
Standard Deviation 178.00
|
592.0 cells/uL
Standard Deviation 156.93
|
755.0 cells/uL
Standard Deviation 145.8
|
553.0 cells/uL
Standard Deviation 288.67
|
—
|
—
|
|
Pharmacodynamic Effect of VIS649 on Circulating CD4 T Cells for All Participants in Cohorts 1-4
Week 4
|
813.0 cells/uL
Standard Deviation 233.06
|
601.5 cells/uL
Standard Deviation 91.92
|
631.0 cells/uL
Standard Deviation 182.52
|
733.0 cells/uL
Standard Deviation 194.08
|
592.0 cells/uL
Standard Deviation 337.55
|
—
|
—
|
|
Pharmacodynamic Effect of VIS649 on Circulating CD4 T Cells for All Participants in Cohorts 1-4
Week 16
|
799.0 cells/uL
Standard Deviation 208.09
|
608.0 cells/uL
Standard Deviation 153.29
|
649.0 cells/uL
Standard Deviation 198.87
|
718 cells/uL
Standard Deviation 127.74
|
606.0 cells/uL
Standard Deviation 347.79
|
—
|
—
|
|
Pharmacodynamic Effect of VIS649 on Circulating CD4 T Cells for All Participants in Cohorts 1-4
Week 20
|
738.0 cells/uL
Standard Deviation 255.19
|
895.0 cells/uL
Standard Deviation 279.84
|
—
|
—
|
630.0 cells/uL
Standard Deviation 300.58
|
—
|
—
|
|
Pharmacodynamic Effect of VIS649 on Circulating CD4 T Cells for All Participants in Cohorts 1-4
Week 24
|
992.0 cells/uL
Standard Deviation 374.77
|
917.0 cells/uL
Standard Deviation 245.42
|
—
|
—
|
499.0 cells/uL
Standard Deviation 196.44
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline to Week 24Population: Pharmacodynamic population: the Safety Population subset with at least 1 pharmacodynamic parameter assessment post study drug dosing.
The effect of VIS649 treatment on the population of circulating CD3 T cells in serum for all participants in cohorts 1-4.
Outcome measures
| Measure |
VIS649 Cohort 4
n=7 Participants
A single dose (12 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Pooled Placebo
n=8 Participants
Single IV dose of placebo will be administered via IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 1
n=7 Participants
A single dose (0.5 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 2
n=7 Participants
A single dose (2.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 3
n=7 Participants
A single dose (6.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Placebo Cohort 5 + Vaccine
Single dose of placebo followed by single dose of vaccine
|
VIS649 Cohort 5 + Vaccine
Single dose of 6.0 mg/kg VIS649 followed by single dose of vaccine
|
|---|---|---|---|---|---|---|---|
|
Pharmacodynamic Effect of VIS649 on Circulating CD3 T Cells for All Participants in Cohorts 1-4
Week 16
|
1270.0 cells/uL
Standard Deviation 367.31
|
1025.0 cells/uL
Standard Deviation 300.38
|
1085.0 cells/uL
Standard Deviation 220.178
|
1082.0 cells/uL
Standard Deviation 140.94
|
1208.0 cells/uL
Standard Deviation 437.35
|
—
|
—
|
|
Pharmacodynamic Effect of VIS649 on Circulating CD3 T Cells for All Participants in Cohorts 1-4
Baseline
|
991.0 cells/uL
Standard Deviation 318.12
|
1147.5 cells/uL
Standard Deviation 313.07
|
1118.0 cells/uL
Standard Deviation 284.46
|
1218.0 cells/uL
Standard Deviation 200.20
|
985.0 cells/uL
Standard Deviation 365.33
|
—
|
—
|
|
Pharmacodynamic Effect of VIS649 on Circulating CD3 T Cells for All Participants in Cohorts 1-4
Week 4
|
1226.0 cells/uL
Standard Deviation 433.57
|
1074.0 cells/uL
Standard Deviation 186.09
|
993.0 cells/uL
Standard Deviation 292.84
|
1110.0 cells/uL
Standard Deviation 358.19
|
1018.0 cells/uL
Standard Deviation 407.5
|
—
|
—
|
|
Pharmacodynamic Effect of VIS649 on Circulating CD3 T Cells for All Participants in Cohorts 1-4
Week 20
|
1139.0 cells/uL
Standard Deviation 558.77
|
1565.0 cells/uL
Standard Deviation 340.67
|
—
|
—
|
970.0 cells/uL
Standard Deviation 387.46
|
—
|
—
|
|
Pharmacodynamic Effect of VIS649 on Circulating CD3 T Cells for All Participants in Cohorts 1-4
Week 24
|
1259.0 cells/uL
Standard Deviation 722.50
|
1644.5 cells/uL
Standard Deviation 299.56
|
—
|
—
|
868.0 cells/uL
Standard Deviation 207.34
|
—
|
—
|
SECONDARY outcome
Timeframe: From baseline to Week 24Population: Pharmacodynamic population: the Safety Population subset with at least 1 pharmacodynamic parameter assessment post study drug dosing.
The effect of VIS649 treatment on the population of circulating CD8 T cells in serum for all participants in cohorts 1-4.
Outcome measures
| Measure |
VIS649 Cohort 4
n=7 Participants
A single dose (12 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Pooled Placebo
n=8 Participants
Single IV dose of placebo will be administered via IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 1
n=7 Participants
A single dose (0.5 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 2
n=7 Participants
A single dose (2.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 3
n=7 Participants
A single dose (6.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Placebo Cohort 5 + Vaccine
Single dose of placebo followed by single dose of vaccine
|
VIS649 Cohort 5 + Vaccine
Single dose of 6.0 mg/kg VIS649 followed by single dose of vaccine
|
|---|---|---|---|---|---|---|---|
|
Pharmacodynamic Effect of VIS649 on Circulating CD8 T Cells for All Participants in Cohorts 1-4
Baseline
|
327 cells/uL
Standard Deviation 199.67
|
483.5 cells/uL
Standard Deviation 145.06
|
442.0 cells/uL
Standard Deviation 165.29
|
356.0 cells/uL
Standard Deviation 103.21
|
373.0 cells/uL
Standard Deviation 108.08
|
—
|
—
|
|
Pharmacodynamic Effect of VIS649 on Circulating CD8 T Cells for All Participants in Cohorts 1-4
Week 4
|
397.0 cells/uL
Standard Deviation 246.05
|
424.0 cells/uL
Standard Deviation 112.24
|
338.0 cells/uL
Standard Deviation 135.81
|
373.0 cells/uL
Standard Deviation 152.41
|
370.0 cells/uL
Standard Deviation 129.55
|
—
|
—
|
|
Pharmacodynamic Effect of VIS649 on Circulating CD8 T Cells for All Participants in Cohorts 1-4
Week 20
|
416.0 cells/uL
Standard Deviation 359.67
|
623.0 cells/uL
Standard Deviation 110.15
|
—
|
—
|
362.0 cells/uL
Standard Deviation 145.02
|
—
|
—
|
|
Pharmacodynamic Effect of VIS649 on Circulating CD8 T Cells for All Participants in Cohorts 1-4
Week 24
|
342.0 cells/uL
Standard Deviation 443.94
|
702.0 cells/uL
Standard Deviation 86.56
|
—
|
—
|
322.0 cells/uL
Standard Deviation 66.27
|
—
|
—
|
|
Pharmacodynamic Effect of VIS649 on Circulating CD8 T Cells for All Participants in Cohorts 1-4
Week 16
|
461.0 cells/uL
Standard Deviation 210.56
|
373.0 cells/uL
Standard Deviation 166.71
|
471.0 cells/uL
Standard Deviation 66.20
|
349.0 cells/uL
Standard Deviation 66.96
|
391.0 cells/uL
Standard Deviation 137.52
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Day 112Population: Safety Population
Summary of Anti -VIS649 anti-drug antibodies (ADA) by treatment group, all participants
Outcome measures
| Measure |
VIS649 Cohort 4
n=7 Participants
A single dose (12 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Pooled Placebo
n=8 Participants
Single IV dose of placebo will be administered via IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 1
n=7 Participants
A single dose (0.5 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 2
n=7 Participants
A single dose (2.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 3
n=7 Participants
A single dose (6.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Placebo Cohort 5 + Vaccine
n=5 Participants
Single dose of placebo followed by single dose of vaccine
|
VIS649 Cohort 5 + Vaccine
n=10 Participants
Single dose of 6.0 mg/kg VIS649 followed by single dose of vaccine
|
|---|---|---|---|---|---|---|---|
|
Summary of Anti -VIS649 Anti-drug Antibodies (ADA)
Baseline · Negative
|
7 Participants
|
8 Participants
|
7 Participants
|
7 Participants
|
7 Participants
|
5 Participants
|
10 Participants
|
|
Summary of Anti -VIS649 Anti-drug Antibodies (ADA)
Baseline · Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Summary of Anti -VIS649 Anti-drug Antibodies (ADA)
Week 4 · Negative
|
7 Participants
|
8 Participants
|
7 Participants
|
7 Participants
|
7 Participants
|
5 Participants
|
8 Participants
|
|
Summary of Anti -VIS649 Anti-drug Antibodies (ADA)
Week 4 · Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Summary of Anti -VIS649 Anti-drug Antibodies (ADA)
Week 8 · Negative
|
6 Participants
|
8 Participants
|
6 Participants
|
5 Participants
|
7 Participants
|
5 Participants
|
8 Participants
|
|
Summary of Anti -VIS649 Anti-drug Antibodies (ADA)
Week 8 · Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Summary of Anti -VIS649 Anti-drug Antibodies (ADA)
Week 16 · Negative
|
3 Participants
|
8 Participants
|
7 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
7 Participants
|
|
Summary of Anti -VIS649 Anti-drug Antibodies (ADA)
Week 16 · Positive
|
4 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 112Population: Safety Population
Summary of Anti -VIS649 antibody (ADA) titer by treatment, all participants with ADA positive results
Outcome measures
| Measure |
VIS649 Cohort 4
n=4 Participants
A single dose (12 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Pooled Placebo
Single IV dose of placebo will be administered via IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 1
A single dose (0.5 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 2
n=3 Participants
A single dose (2.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 3
n=2 Participants
A single dose (6.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Placebo Cohort 5 + Vaccine
Single dose of placebo followed by single dose of vaccine
|
VIS649 Cohort 5 + Vaccine
n=4 Participants
Single dose of 6.0 mg/kg VIS649 followed by single dose of vaccine
|
|---|---|---|---|---|---|---|---|
|
Summary of Anti -VIS649 Antibody (ADA) Titer by Treatment
Week 4
|
—
|
—
|
—
|
—
|
—
|
—
|
1.0 titer
|
|
Summary of Anti -VIS649 Antibody (ADA) Titer by Treatment
Week 8
|
—
|
—
|
—
|
0.0 titer
|
—
|
—
|
0.0 titer
|
|
Summary of Anti -VIS649 Antibody (ADA) Titer by Treatment
Week 16
|
6.0 titer
Standard Deviation 6.83
|
—
|
—
|
32.0 titer
Standard Deviation 45.25
|
18.0 titer
Standard Deviation 19.80
|
—
|
2.0 titer
Standard Deviation 2.83
|
SECONDARY outcome
Timeframe: 0, 1, 2, 8, and 24-hours post-dose, Day 3, 7, 14, 28, 42, 56, 70, and 112.Population: Pharmacokinetic Population (all randomized participants with at least 1 quantifiable VIS649 concentration).
The maximum serum concentration (Cmax) of VIS649 determined by an electrochemiluminescence (ECL) immunoassay and analyzed by standard non-compartmental pharmacokinetic methods. All participants by anti-VIS649 status (positive or negative).
Outcome measures
| Measure |
VIS649 Cohort 4
n=10 Participants
A single dose (12 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Pooled Placebo
n=7 Participants
Single IV dose of placebo will be administered via IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 1
n=7 Participants
A single dose (0.5 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 2
n=7 Participants
A single dose (2.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 3
n=7 Participants
A single dose (6.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Placebo Cohort 5 + Vaccine
Single dose of placebo followed by single dose of vaccine
|
VIS649 Cohort 5 + Vaccine
Single dose of 6.0 mg/kg VIS649 followed by single dose of vaccine
|
|---|---|---|---|---|---|---|---|
|
Cmax: Maximum Serum VIS649 Concentration Determined Directly From the Concentration-time Profile. All Participants by Anti-VIS649 Status
Negative
|
136.300 μg/mL
Standard Deviation 18.420
|
12.600 μg/mL
Standard Deviation 2.222
|
48.660 μg/mL
Standard Deviation 12.040
|
134.100 μg/mL
Standard Deviation 23.730
|
259.000 μg/mL
Standard Deviation 65.110
|
—
|
—
|
|
Cmax: Maximum Serum VIS649 Concentration Determined Directly From the Concentration-time Profile. All Participants by Anti-VIS649 Status
Positive
|
117.700 μg/mL
Standard Deviation 21.140
|
—
|
48.450 μg/mL
Standard Deviation 15.340
|
140.500 μg/mL
Standard Deviation 13.440
|
300.300 μg/mL
Standard Deviation 29.900
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 1, 2, 8, and 24-hours post-dose, Day 3, 7, 14, 28, 42, 56, 70, and 112.Population: Pharmacokinetic Population (all randomized participants with at least 1 quantifiable VIS649 concentration).
The time to the maximum serum concentration (tmax) of VIS649 as determined by an electrochemiluminescence (ECL) immunoassay and analyzed by standard non-compartmental pharmacokinetic methods. All participants by anti-VIS649 status (positive or negative).
Outcome measures
| Measure |
VIS649 Cohort 4
n=10 Participants
A single dose (12 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Pooled Placebo
n=7 Participants
Single IV dose of placebo will be administered via IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 1
n=7 Participants
A single dose (0.5 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 2
n=7 Participants
A single dose (2.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 3
n=7 Participants
A single dose (6.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Placebo Cohort 5 + Vaccine
Single dose of placebo followed by single dose of vaccine
|
VIS649 Cohort 5 + Vaccine
Single dose of 6.0 mg/kg VIS649 followed by single dose of vaccine
|
|---|---|---|---|---|---|---|---|
|
Tmax: Time to the Maximum Serum VIS649 Concentration Determined Directly From the Concentration-time Profile. All Participants by Anti-VIS649 Status
Negative
|
3.049 hours
Interval 1.14 to 25.11
|
1.136 hours
Interval 1.12 to 3.11
|
1.434 hours
Interval 1.15 to 3.09
|
3.038 hours
Interval 1.14 to 3.16
|
3.064 hours
Interval 1.11 to 9.11
|
—
|
—
|
|
Tmax: Time to the Maximum Serum VIS649 Concentration Determined Directly From the Concentration-time Profile. All Participants by Anti-VIS649 Status
Positive
|
3.055 hours
Interval 3.05 to 3.07
|
—
|
3.058 hours
Interval 3.05 to 3.07
|
2.089 hours
Interval 1.13 to 3.05
|
1.142 hours
Interval 1.12 to 3.09
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 1, 2, 8, and 24-hours post-dose, Day 3, 7, 14, 28, 42, 56, 70, and 112.Population: Pharmacokinetic Population (all randomized participants with at least 1 quantifiable VIS649 concentration) including all ethnicities.
Summary of the pharmacokinetic profiles of VIS649 exposure in serum for all participants based on their anti-VIS649 antibody status (negative/positive). AUC0-112 presents the area under the concentration time curve from pre-dose (time 0) to the concentration on day 112. AUC0-last presents the area under the concentration time curve from pre-dose (time 0) to the last quantifiable concentration. AUC0-inf presents the area under the concentration time curve from pre-dose (time 0) extrapolated to infinite time.
Outcome measures
| Measure |
VIS649 Cohort 4
n=10 Participants
A single dose (12 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Pooled Placebo
n=7 Participants
Single IV dose of placebo will be administered via IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 1
n=7 Participants
A single dose (0.5 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 2
n=7 Participants
A single dose (2.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 3
n=7 Participants
A single dose (6.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Placebo Cohort 5 + Vaccine
Single dose of placebo followed by single dose of vaccine
|
VIS649 Cohort 5 + Vaccine
Single dose of 6.0 mg/kg VIS649 followed by single dose of vaccine
|
|---|---|---|---|---|---|---|---|
|
The Pharmacokinetic Exposure Profiles of VIS649 in Serum Samples, All Participants by Anti-VIS649 Antibody Status.
AUC 0-112 days--ADA Negative participants
|
56390 h*μg/mL
Standard Deviation 17870
|
1118 h*μg/mL
Standard Deviation 209.400
|
12270 h*μg/mL
Standard Deviation 3876
|
71440 h*μg/mL
Standard Deviation 19090
|
177700 h*μg/mL
Standard Deviation 31330
|
—
|
—
|
|
The Pharmacokinetic Exposure Profiles of VIS649 in Serum Samples, All Participants by Anti-VIS649 Antibody Status.
AUC 0-112 days--ADA Positive participants
|
61450 h*μg/mL
Standard Deviation 23170
|
—
|
10200 h*μg/mL
Standard Deviation 1805
|
82120 h*μg/mL
Standard Deviation 21210
|
175300 h*μg/mL
Standard Deviation 26540
|
—
|
—
|
|
The Pharmacokinetic Exposure Profiles of VIS649 in Serum Samples, All Participants by Anti-VIS649 Antibody Status.
AUC 0-last--ADA negative participants
|
51550 h*μg/mL
Standard Deviation 17860
|
885.2 h*μg/mL
Standard Deviation 146.200
|
10750 h*μg/mL
Standard Deviation 3277
|
69700 h*μg/mL
Standard Deviation 20050
|
145100 h*μg/mL
Standard Deviation 16950
|
—
|
—
|
|
The Pharmacokinetic Exposure Profiles of VIS649 in Serum Samples, All Participants by Anti-VIS649 Antibody Status.
AUC 0-last--ADA positive participants
|
58500 h*μg/mL
Standard Deviation 21880
|
—
|
9922 h*μg/mL
Standard Deviation 1863
|
80410 h*μg/mL
Standard Deviation 21040
|
151800 h*μg/mL
Standard Deviation 19810
|
—
|
—
|
|
The Pharmacokinetic Exposure Profiles of VIS649 in Serum Samples, All Participants by Anti-VIS649 Antibody Status.
AUC 0-inf--ADA negative participants
|
56450 h*μg/mL
Standard Deviation 17930
|
1118 h*μg/mL
Standard Deviation 209.500
|
12260 h*μg/mL
Standard Deviation 3878
|
71340 h*μg/mL
Standard Deviation 19120
|
194300 h*μg/mL
Standard Deviation 49280
|
—
|
—
|
|
The Pharmacokinetic Exposure Profiles of VIS649 in Serum Samples, All Participants by Anti-VIS649 Antibody Status.
AUC 0-inf--ADA positive participants
|
61320 h*μg/mL
Standard Deviation 23060
|
—
|
10200 h*μg/mL
Standard Deviation 1806
|
81980 h*μg/mL
Standard Deviation 21350
|
182100 h*μg/mL
Standard Deviation 29760
|
—
|
—
|
SECONDARY outcome
Timeframe: 0, 1, 2, 8, and 24-hours post-dose, Day 3, 7, 14, 28, 42, 56, 70, and 112.Population: Pharmacokinetic Population (all randomized participants with at least 1 quantifiable VIS649 concentration).
The terminal elimination half life (t1/2) of VIS649 from the concentration-time profile as determined by an electrochemiluminescence (ECL) immunoassay and analyzed by standard non-compartmental pharmacokinetic methods. All participants by anti-VIS649 antibody status (negative/positive).
Outcome measures
| Measure |
VIS649 Cohort 4
n=10 Participants
A single dose (12 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Pooled Placebo
n=7 Participants
Single IV dose of placebo will be administered via IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 1
n=7 Participants
A single dose (0.5 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 2
n=7 Participants
A single dose (2.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 3
n=7 Participants
A single dose (6.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Placebo Cohort 5 + Vaccine
Single dose of placebo followed by single dose of vaccine
|
VIS649 Cohort 5 + Vaccine
Single dose of 6.0 mg/kg VIS649 followed by single dose of vaccine
|
|---|---|---|---|---|---|---|---|
|
T1/2 The Terminal Elimination Half Life of VIS649 in Serum Samples. All Participants by Anti-VIS649 Antibody Status.
T1/2 ADA Positive participants
|
358.200 hours
Standard Deviation 95.520
|
—
|
131.900 hours
Standard Deviation 14.750
|
246.600 hours
Standard Deviation 68.520
|
618.8 hours
Standard Deviation 59.450
|
—
|
—
|
|
T1/2 The Terminal Elimination Half Life of VIS649 in Serum Samples. All Participants by Anti-VIS649 Antibody Status.
T1/2 ADA Negative participants
|
335.300 hours
Standard Deviation 96.780
|
60.720 hours
Standard Deviation 4.346
|
192.600 hours
Standard Deviation 29.040
|
224.600 hours
Standard Deviation 85.810
|
738.4 hours
Standard Deviation 281.800
|
—
|
—
|
SECONDARY outcome
Timeframe: 112 daysPopulation: Pharmacokinetic Population (all randomized participants with at least 1 quantifiable VIS649 concentration).
The clearance rate (CL) of VIS649 using the exposure calculated to infinity of VIS649 as determined by an electrochemiluminescence (ECL) immunoassay and analyzed by standard non-compartmental pharmacokinetic methods. All participants by anti-VIS649 antibody status (positive or negative)..
Outcome measures
| Measure |
VIS649 Cohort 4
n=10 Participants
A single dose (12 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Pooled Placebo
n=7 Participants
Single IV dose of placebo will be administered via IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 1
n=7 Participants
A single dose (0.5 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 2
n=7 Participants
A single dose (2.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 3
n=7 Participants
A single dose (6.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Placebo Cohort 5 + Vaccine
Single dose of placebo followed by single dose of vaccine
|
VIS649 Cohort 5 + Vaccine
Single dose of 6.0 mg/kg VIS649 followed by single dose of vaccine
|
|---|---|---|---|---|---|---|---|
|
CL: The Clearance of VIS649 in Serum Samples Calculated Using Exposure Extrapolated to Infinity by Dose. All Participants by Anti-VIS649 Antibody Status.
CL--ADA negative participants
|
9.272 mL/h
Standard Deviation 4.765
|
31.460 mL/h
Standard Deviation 4.544
|
10.870 mL/h
Standard Deviation 2.023
|
6.536 mL/h
Standard Deviation 2.203
|
4.019 mL/h
Standard Deviation 1.500
|
—
|
—
|
|
CL: The Clearance of VIS649 in Serum Samples Calculated Using Exposure Extrapolated to Infinity by Dose. All Participants by Anti-VIS649 Antibody Status.
CL--ADA positive participants
|
7.445 mL/h
Standard Deviation 2.324
|
—
|
13.750 mL/h
Standard Deviation 3.153
|
5.097 mL/h
Standard Deviation 2.890
|
4.875 mL/h
Standard Deviation 1.364
|
—
|
—
|
SECONDARY outcome
Timeframe: 112 daysPopulation: Pharmacokinetic Population (all randomized participants with at least 1 quantifiable VIS649 concentration).
The calculated volume of distribution of VIS649 as determined by an electrochemiluminescence (ECL) immunoassay and analyzed by standard non-compartmental pharmacokinetic methods. All participants by anti-VIS649 antibody status (positive or negative).
Outcome measures
| Measure |
VIS649 Cohort 4
n=10 Participants
A single dose (12 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Pooled Placebo
n=7 Participants
Single IV dose of placebo will be administered via IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 1
n=7 Participants
A single dose (0.5 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 2
n=7 Participants
A single dose (2.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 3
n=7 Participants
A single dose (6.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Placebo Cohort 5 + Vaccine
Single dose of placebo followed by single dose of vaccine
|
VIS649 Cohort 5 + Vaccine
Single dose of 6.0 mg/kg VIS649 followed by single dose of vaccine
|
|---|---|---|---|---|---|---|---|
|
Vd: The Volume of Distribution of VIS649 in Serum Samples. All Participants by Anti-VIS649 Antibody Status (Positive or Negative)
Vd--ADA negative
|
4026 mL
Standard Deviation 983.8
|
2747 mL
Standard Deviation 351.600
|
2961 mL
Standard Deviation 287.200
|
2274 mL
Standard Deviation 1474
|
3894 mL
Standard Deviation 548.8
|
—
|
—
|
|
Vd: The Volume of Distribution of VIS649 in Serum Samples. All Participants by Anti-VIS649 Antibody Status (Positive or Negative)
Vd--ADA positive
|
3641 mL
Standard Deviation 171.100
|
—
|
2584 mL
Standard Deviation 307.500
|
1956 mL
Standard Deviation 1532
|
4292 mL
Standard Deviation 962.6
|
—
|
—
|
Adverse Events
Pooled Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
VIS649 Cohort 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
VIS649 Cohort 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
VIS649 Cohort 3
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
VIS649 Cohort 4
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo Cohort 5 + Vaccine
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
VIS649 Cohort 5 + Vaccine
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pooled Placebo
n=8 participants at risk
Single IV dose of placebo will be administered via IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 1
n=7 participants at risk
A single dose (0.5 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 2
n=7 participants at risk
A single dose (2.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 3
n=7 participants at risk
A single dose (6.0 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
VIS649 Cohort 4
n=7 participants at risk
A single dose (12 mg/kg) of VIS649 administered IV over approximately 1 hour on Day 1.
|
Placebo Cohort 5 + Vaccine
n=5 participants at risk
Single dose of placebo followed by single dose of vaccine
|
VIS649 Cohort 5 + Vaccine
n=10 participants at risk
Single dose of 6.0 mg/kg VIS649 followed by single dose of vaccine
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Infections and infestations
|
12.5%
1/8 • Number of events 1 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
14.3%
1/7 • Number of events 1 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
14.3%
1/7 • Number of events 1 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
14.3%
1/7 • Number of events 1 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
0.00%
0/7 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
40.0%
2/5 • Number of events 2 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
10.0%
1/10 • Number of events 1 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
|
Gastrointestinal disorders
Diarrhoea, Food poisoning, Constipation, or Vomiting
|
12.5%
1/8 • Number of events 1 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
0.00%
0/7 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
14.3%
1/7 • Number of events 1 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
14.3%
1/7 • Number of events 1 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
28.6%
2/7 • Number of events 2 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
40.0%
2/5 • Number of events 2 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
0.00%
0/10 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
|
General disorders
General disorders and administration site conditions
|
25.0%
2/8 • Number of events 2 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
0.00%
0/7 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
14.3%
1/7 • Number of events 1 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
14.3%
1/7 • Number of events 1 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
14.3%
1/7 • Number of events 1 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
20.0%
1/5 • Number of events 1 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
10.0%
1/10 • Number of events 1 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
|
Nervous system disorders
Dizziness, Headache, Head discomfort, Migraine, Somnolence, Syncope, or Taste disorder
|
12.5%
1/8 • Number of events 1 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
14.3%
1/7 • Number of events 1 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
28.6%
2/7 • Number of events 2 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
28.6%
2/7 • Number of events 2 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
14.3%
1/7 • Number of events 1 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
0.00%
0/5 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
0.00%
0/10 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
|
Injury, poisoning and procedural complications
Sunburn
|
12.5%
1/8 • Number of events 1 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
0.00%
0/7 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
0.00%
0/7 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
0.00%
0/7 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
0.00%
0/7 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
0.00%
0/5 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
10.0%
1/10 • Number of events 1 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
|
Musculoskeletal and connective tissue disorders
Back pain or Myalgia
|
0.00%
0/8 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
0.00%
0/7 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
14.3%
1/7 • Number of events 1 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
14.3%
1/7 • Number of events 1 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
0.00%
0/7 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
0.00%
0/5 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
0.00%
0/10 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain or Sneezing
|
12.5%
1/8 • Number of events 1 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
0.00%
0/7 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
0.00%
0/7 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
0.00%
0/7 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
0.00%
0/7 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
0.00%
0/5 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
10.0%
1/10 • Number of events 1 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/8 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
0.00%
0/7 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
0.00%
0/7 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
0.00%
0/7 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
14.3%
1/7 • Number of events 1 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
20.0%
1/5 • Number of events 1 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
0.00%
0/10 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
|
Eye disorders
Blepharitis
|
0.00%
0/8 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
0.00%
0/7 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
0.00%
0/7 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
0.00%
0/7 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
14.3%
1/7 • Number of events 1 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
0.00%
0/5 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
0.00%
0/10 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/8 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
0.00%
0/7 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
0.00%
0/7 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
0.00%
0/7 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
14.3%
1/7 • Number of events 1 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
0.00%
0/5 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
0.00%
0/10 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
0.00%
0/8 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
0.00%
0/7 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
14.3%
1/7 • Number of events 1 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
0.00%
0/7 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
0.00%
0/7 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
0.00%
0/5 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
0.00%
0/10 • From Day -1 to Day 112
Standard definitions of adverse and serious adverse event were used. Severity was either mild, moderate or severe as determined by the investigator using standard criteria in the protocol. All participants were monitored in the clinic for 24 hours post dose. Additional clinical visits occurred on days 3, 7, 14, 21, 28, 35, 42, 49, 56, 70, 84, 98, 112.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place