Trial Outcomes & Findings for Safety, Tolerability, and Pharmacokinetics of SAB-176 in Healthy Participants (NCT NCT04471038)
NCT ID: NCT04471038
Last Updated: 2025-01-06
Results Overview
Incidence and severity of other adverse events and severe adverse events (SAE)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
27 participants
Primary outcome timeframe
90 days
Results posted on
2025-01-06
Participant Flow
Participant milestones
| Measure |
Cohort 1
1 mg/mL SAB-176 in normal (0.9%) Saline; concentration 1 mg/mL (0.1%)
SAB-176: Anti-Influenza Human Immunoglobulin Intravenous (Tc bovine derived)
|
Cohort 2
10 mg/kgSAB-176 in normal (0.9%) Saline; concentration 4 mg/mL (0.4%)
SAB-176: Anti-Influenza Human Immunoglobulin Intravenous (Tc bovine derived)
|
Cohort 3
25 mg/kgSAB-176 in normal (0.9%) Saline; concentration 20 mg/mL (2.0%)
SAB-176: Anti-Influenza Human Immunoglobulin Intravenous (Tc bovine derived)
|
Cohort 4
50 mg/kg SAB-176 in normal (0.9%) Saline; concentration 20 mg/mL (2.0%)
SAB-176: Anti-Influenza Human Immunoglobulin Intravenous (Tc bovine derived)
|
Cohort 5
Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm.
Normal Saline: Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
4
|
6
|
8
|
7
|
|
Overall Study
COMPLETED
|
2
|
4
|
6
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Tolerability, and Pharmacokinetics of SAB-176 in Healthy Participants
Baseline characteristics by cohort
| Measure |
Cohort 1
n=2 Participants
1 mg/mL SAB-176 in normal (0.9%) Saline; concentration 1 mg/mL (0.1%)
SAB-176: Anti-Influenza Human Immunoglobulin Intravenous (Tc bovine derived)
|
Cohort 2
n=4 Participants
10 mg/kgSAB-176 in normal (0.9%) Saline; concentration 4 mg/mL (0.4%)
SAB-176: Anti-Influenza Human Immunoglobulin Intravenous (Tc bovine derived)
|
Cohort 3
n=6 Participants
25 mg/kgSAB-176 in normal (0.9%) Saline; concentration 20 mg/mL (2.0%)
SAB-176: Anti-Influenza Human Immunoglobulin Intravenous (Tc bovine derived)
|
Cohort 4
n=8 Participants
50 mg/kg SAB-176 in normal (0.9%) Saline; concentration 20 mg/mL (2.0%)
SAB-176: Anti-Influenza Human Immunoglobulin Intravenous (Tc bovine derived)
|
Cohort 5
n=7 Participants
Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm.
Normal Saline: Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
|
29.0 years
STANDARD_DEVIATION 5.66 • n=5 Participants
|
43.3 years
STANDARD_DEVIATION 14.41 • n=7 Participants
|
40.5 years
STANDARD_DEVIATION 10.07 • n=5 Participants
|
34.1 years
STANDARD_DEVIATION 7.72 • n=4 Participants
|
35.7 years
STANDARD_DEVIATION 9.95 • n=21 Participants
|
36.9 years
STANDARD_DEVIATION 10.02 • n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Screening Weight (kg)
|
76.10 kg
STANDARD_DEVIATION 18.950 • n=5 Participants
|
62.68 kg
STANDARD_DEVIATION 11.054 • n=7 Participants
|
85.95 kg
STANDARD_DEVIATION 18.888 • n=5 Participants
|
85.26 kg
STANDARD_DEVIATION 10.859 • n=4 Participants
|
72.67 kg
STANDARD_DEVIATION 11.226 • n=21 Participants
|
78.13 kg
STANDARD_DEVIATION 15.242 • n=8 Participants
|
|
Screening BMI
|
28.70 kg/m^2
STANDARD_DEVIATION 0.707 • n=5 Participants
|
23.95 kg/m^2
STANDARD_DEVIATION 4.779 • n=7 Participants
|
27.95 kg/m^2
STANDARD_DEVIATION 3.500 • n=5 Participants
|
28.58 kg/m^2
STANDARD_DEVIATION 2.230 • n=4 Participants
|
26.13 kg/m^2
STANDARD_DEVIATION 4.389 • n=21 Participants
|
27.13 kg/m^2
STANDARD_DEVIATION 3.689 • n=8 Participants
|
PRIMARY outcome
Timeframe: 90 daysPopulation: At each level of subject summarization, a subject is counted once if the subject reported one or more events.
Incidence and severity of other adverse events and severe adverse events (SAE)
Outcome measures
| Measure |
Cohort 1
n=2 Participants
1 mg/mL SAB-176 in normal (0.9%) Saline; concentration 1 mg/mL (0.1%)
SAB-176: Anti-Influenza Human Immunoglobulin Intravenous (Tc bovine derived)
|
Cohort 2
n=4 Participants
10 mg/kgSAB-176 in normal (0.9%) Saline; concentration 4 mg/mL (0.4%)
SAB-176: Anti-Influenza Human Immunoglobulin Intravenous (Tc bovine derived)
|
Cohort 3
n=6 Participants
25 mg/kgSAB-176 in normal (0.9%) Saline; concentration 20 mg/mL (2.0%)
SAB-176: Anti-Influenza Human Immunoglobulin Intravenous (Tc bovine derived)
|
Cohort 4
n=8 Participants
50 mg/kg SAB-176 in normal (0.9%) Saline; concentration 20 mg/mL (2.0%)
SAB-176: Anti-Influenza Human Immunoglobulin Intravenous (Tc bovine derived)
|
Cohort 5
n=7 Participants
Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm.
Normal Saline: Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm
|
|---|---|---|---|---|---|
|
Number of Participants Having Adverse Events
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 90 DaysPopulation: Subjects who received SAB-176 or placebo with 1 or more samples obtained after SAB-176 or placebo administration.
Number of subjects showing antidrug antibodies to SAB-176 through day 90
Outcome measures
| Measure |
Cohort 1
n=2 Participants
1 mg/mL SAB-176 in normal (0.9%) Saline; concentration 1 mg/mL (0.1%)
SAB-176: Anti-Influenza Human Immunoglobulin Intravenous (Tc bovine derived)
|
Cohort 2
n=4 Participants
10 mg/kgSAB-176 in normal (0.9%) Saline; concentration 4 mg/mL (0.4%)
SAB-176: Anti-Influenza Human Immunoglobulin Intravenous (Tc bovine derived)
|
Cohort 3
n=6 Participants
25 mg/kgSAB-176 in normal (0.9%) Saline; concentration 20 mg/mL (2.0%)
SAB-176: Anti-Influenza Human Immunoglobulin Intravenous (Tc bovine derived)
|
Cohort 4
n=8 Participants
50 mg/kg SAB-176 in normal (0.9%) Saline; concentration 20 mg/mL (2.0%)
SAB-176: Anti-Influenza Human Immunoglobulin Intravenous (Tc bovine derived)
|
Cohort 5
Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm.
Normal Saline: Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm
|
|---|---|---|---|---|---|
|
Number of Participants With Anti-SAB-176 Antibodies Elicited by SAB-176
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 4
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 5
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1
n=2 participants at risk
1 mg/mL SAB-176 in normal (0.9%) Saline; concentration 1 mg/mL (0.1%)
SAB-176: Anti-Influenza Human Immunoglobulin Intravenous (Tc bovine derived)
|
Cohort 2
n=4 participants at risk
10 mg/kgSAB-176 in normal (0.9%) Saline; concentration 4 mg/mL (0.4%)
SAB-176: Anti-Influenza Human Immunoglobulin Intravenous (Tc bovine derived)
|
Cohort 3
n=6 participants at risk
25 mg/kgSAB-176 in normal (0.9%) Saline; concentration 20 mg/mL (2.0%)
SAB-176: Anti-Influenza Human Immunoglobulin Intravenous (Tc bovine derived)
|
Cohort 4
n=8 participants at risk
50 mg/kg SAB-176 in normal (0.9%) Saline; concentration 20 mg/mL (2.0%)
SAB-176: Anti-Influenza Human Immunoglobulin Intravenous (Tc bovine derived)
|
Cohort 5
n=7 participants at risk
Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm.
Normal Saline: Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm
|
|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/2 • AEs that occur following enrollment of the subject (by signing the informed consent) through the follow up period at Day 90.
|
0.00%
0/4 • AEs that occur following enrollment of the subject (by signing the informed consent) through the follow up period at Day 90.
|
16.7%
1/6 • Number of events 1 • AEs that occur following enrollment of the subject (by signing the informed consent) through the follow up period at Day 90.
|
12.5%
1/8 • Number of events 1 • AEs that occur following enrollment of the subject (by signing the informed consent) through the follow up period at Day 90.
|
14.3%
1/7 • Number of events 1 • AEs that occur following enrollment of the subject (by signing the informed consent) through the follow up period at Day 90.
|
|
Eye disorders
Photophobia
|
0.00%
0/2 • AEs that occur following enrollment of the subject (by signing the informed consent) through the follow up period at Day 90.
|
25.0%
1/4 • Number of events 1 • AEs that occur following enrollment of the subject (by signing the informed consent) through the follow up period at Day 90.
|
0.00%
0/6 • AEs that occur following enrollment of the subject (by signing the informed consent) through the follow up period at Day 90.
|
0.00%
0/8 • AEs that occur following enrollment of the subject (by signing the informed consent) through the follow up period at Day 90.
|
0.00%
0/7 • AEs that occur following enrollment of the subject (by signing the informed consent) through the follow up period at Day 90.
|
|
General disorders
Asthemia
|
0.00%
0/2 • AEs that occur following enrollment of the subject (by signing the informed consent) through the follow up period at Day 90.
|
25.0%
1/4 • Number of events 1 • AEs that occur following enrollment of the subject (by signing the informed consent) through the follow up period at Day 90.
|
0.00%
0/6 • AEs that occur following enrollment of the subject (by signing the informed consent) through the follow up period at Day 90.
|
0.00%
0/8 • AEs that occur following enrollment of the subject (by signing the informed consent) through the follow up period at Day 90.
|
0.00%
0/7 • AEs that occur following enrollment of the subject (by signing the informed consent) through the follow up period at Day 90.
|
|
Musculoskeletal and connective tissue disorders
Muscular skeletal pain
|
0.00%
0/2 • AEs that occur following enrollment of the subject (by signing the informed consent) through the follow up period at Day 90.
|
0.00%
0/4 • AEs that occur following enrollment of the subject (by signing the informed consent) through the follow up period at Day 90.
|
0.00%
0/6 • AEs that occur following enrollment of the subject (by signing the informed consent) through the follow up period at Day 90.
|
0.00%
0/8 • AEs that occur following enrollment of the subject (by signing the informed consent) through the follow up period at Day 90.
|
14.3%
1/7 • Number of events 1 • AEs that occur following enrollment of the subject (by signing the informed consent) through the follow up period at Day 90.
|
|
Skin and subcutaneous tissue disorders
skin irritation
|
0.00%
0/2 • AEs that occur following enrollment of the subject (by signing the informed consent) through the follow up period at Day 90.
|
0.00%
0/4 • AEs that occur following enrollment of the subject (by signing the informed consent) through the follow up period at Day 90.
|
0.00%
0/6 • AEs that occur following enrollment of the subject (by signing the informed consent) through the follow up period at Day 90.
|
0.00%
0/8 • AEs that occur following enrollment of the subject (by signing the informed consent) through the follow up period at Day 90.
|
14.3%
1/7 • Number of events 1 • AEs that occur following enrollment of the subject (by signing the informed consent) through the follow up period at Day 90.
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • AEs that occur following enrollment of the subject (by signing the informed consent) through the follow up period at Day 90.
|
25.0%
1/4 • Number of events 1 • AEs that occur following enrollment of the subject (by signing the informed consent) through the follow up period at Day 90.
|
0.00%
0/6 • AEs that occur following enrollment of the subject (by signing the informed consent) through the follow up period at Day 90.
|
0.00%
0/8 • AEs that occur following enrollment of the subject (by signing the informed consent) through the follow up period at Day 90.
|
0.00%
0/7 • AEs that occur following enrollment of the subject (by signing the informed consent) through the follow up period at Day 90.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place