Trial Outcomes & Findings for Safety, Tolerability, and Pharmacokinetics of SAB-301 in Healthy Adults (NCT NCT02788188)
NCT ID: NCT02788188
Last Updated: 2018-06-12
Results Overview
Number of participants who experienced an adverse event
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
38 participants
Primary outcome timeframe
90 days
Results posted on
2018-06-12
Participant Flow
Participant milestones
| Measure |
Cohort 1: 1.0mg/kg
SAB-301 1 mg/kg IV single infusion
|
Cohort 2: 2.5mg/kg
SAB-301 2.5 mg/kg IV single infusion
|
Cohort 3: 5mg/kg
SAB-301 5 mg/kg IV single infusion
|
Cohort 4: 10mg/kg
SAB-301 10 mg/kg IV single infusion
|
Cohort 5: 20mg/kg
SAB-301 20 mg/kg IV single infusion
|
Cohort 6: 50mg/kg
SAB-301 50 mg/kg IV single infusion
|
Placebo
Normal Saline IV single infusion
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
4
|
4
|
8
|
8
|
10
|
|
Overall Study
COMPLETED
|
2
|
2
|
4
|
4
|
8
|
8
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Tolerability, and Pharmacokinetics of SAB-301 in Healthy Adults
Baseline characteristics by cohort
| Measure |
Cohort 1: 1.0mg/kg
n=2 Participants
SAB-301 1 mg/kg IV single infusion
|
Cohort 2: 2.5mg/kg
n=2 Participants
SAB-301 2.5 mg/kg IV single infusion
|
Cohort 3: 5mg/kg
n=4 Participants
SAB-301 5 mg/kg IV single infusion
|
Cohort 4: 10mg/kg
n=4 Participants
SAB-301 10 mg/kg IV single infusion
|
Cohort 5: 20mg/kg
n=8 Participants
SAB-301 20 mg/kg IV single infusion
|
Cohort 6: 50mg/kg
n=8 Participants
SAB-301 50 mg/kg IV single infusion
|
Placebo
n=10 Participants
Normal Saline IV single infusion
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
38 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
18 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
20 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
35 Participants
n=24 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 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
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
3 Participants
n=24 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
6 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
26 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 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=10 Participants
|
2 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: 90 daysPopulation: Number of participants who completed both treatment and placebo
Number of participants who experienced an adverse event
Outcome measures
| Measure |
Cohort 1: 1.0mg/kg
n=2 Participants
SAB-301 1 mg/kg IV single infusion
|
Cohort 2: 2.5mg/kg
n=2 Participants
SAB-301 2.5 mg/kg IV single infusion
|
Cohort 3: 5mg/kg
n=4 Participants
SAB-301 5 mg/kg IV single infusion
|
Cohort 4: 10mg/kg
n=4 Participants
SAB-301 10 mg/kg IV single infusion
|
Cohort 5: 20mg/kg
n=8 Participants
SAB-301 20 mg/kg IV single infusion
|
Cohort 6: 50mg/kg
n=8 Participants
SAB-301 50 mg/kg IV single infusion
|
Placebo
n=10 Participants
Normal Saline IV single infusion
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Having Adverse Events
|
1 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
7 Participants
|
8 Participants
|
10 Participants
|
Adverse Events
Cohort 1: 1.0mg/kg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2: 2.5mg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 3: 5mg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 4: 10mg/kg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 5: 20mg/kg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 6: 50mg/kg
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: 1.0mg/kg
n=2 participants at risk
SAB-301 1 mg/kg IV single infusion
|
Cohort 2: 2.5mg/kg
n=2 participants at risk
SAB-301 2.5 mg/kg IV single infusion
|
Cohort 3: 5mg/kg
n=4 participants at risk
SAB-301 5 mg/kg IV single infusion
|
Cohort 4: 10mg/kg
n=4 participants at risk
SAB-301 10 mg/kg IV single infusion
|
Cohort 5: 20mg/kg
n=8 participants at risk
SAB-301 20 mg/kg IV single infusion
|
Cohort 6: 50mg/kg
n=8 participants at risk
SAB-301 50 mg/kg IV single infusion
|
Placebo
n=10 participants at risk
Normal Saline IV single infusion
|
|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/8 • 90 Days
|
12.5%
1/8 • 90 Days
|
0.00%
0/10 • 90 Days
|
Other adverse events
| Measure |
Cohort 1: 1.0mg/kg
n=2 participants at risk
SAB-301 1 mg/kg IV single infusion
|
Cohort 2: 2.5mg/kg
n=2 participants at risk
SAB-301 2.5 mg/kg IV single infusion
|
Cohort 3: 5mg/kg
n=4 participants at risk
SAB-301 5 mg/kg IV single infusion
|
Cohort 4: 10mg/kg
n=4 participants at risk
SAB-301 10 mg/kg IV single infusion
|
Cohort 5: 20mg/kg
n=8 participants at risk
SAB-301 20 mg/kg IV single infusion
|
Cohort 6: 50mg/kg
n=8 participants at risk
SAB-301 50 mg/kg IV single infusion
|
Placebo
n=10 participants at risk
Normal Saline IV single infusion
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/8 • 90 Days
|
12.5%
1/8 • 90 Days
|
0.00%
0/10 • 90 Days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
25.0%
1/4 • 90 Days
|
25.0%
1/4 • 90 Days
|
0.00%
0/8 • 90 Days
|
0.00%
0/8 • 90 Days
|
0.00%
0/10 • 90 Days
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
25.0%
1/4 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/8 • 90 Days
|
0.00%
0/8 • 90 Days
|
10.0%
1/10 • 90 Days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/8 • 90 Days
|
0.00%
0/8 • 90 Days
|
10.0%
1/10 • 90 Days
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
25.0%
1/4 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/8 • 90 Days
|
0.00%
0/8 • 90 Days
|
0.00%
0/10 • 90 Days
|
|
General disorders
Fatigue
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
0.00%
0/4 • 90 Days
|
25.0%
1/4 • 90 Days
|
12.5%
1/8 • 90 Days
|
0.00%
0/8 • 90 Days
|
0.00%
0/10 • 90 Days
|
|
General disorders
Pyrexia
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
0.00%
0/4 • 90 Days
|
25.0%
1/4 • 90 Days
|
0.00%
0/8 • 90 Days
|
0.00%
0/8 • 90 Days
|
0.00%
0/10 • 90 Days
|
|
Infections and infestations
Chlamydial infection
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/8 • 90 Days
|
0.00%
0/8 • 90 Days
|
10.0%
1/10 • 90 Days
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
0.00%
0/4 • 90 Days
|
25.0%
1/4 • 90 Days
|
0.00%
0/8 • 90 Days
|
0.00%
0/8 • 90 Days
|
0.00%
0/10 • 90 Days
|
|
Infections and infestations
Impetigo
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
0.00%
0/4 • 90 Days
|
25.0%
1/4 • 90 Days
|
0.00%
0/8 • 90 Days
|
0.00%
0/8 • 90 Days
|
0.00%
0/10 • 90 Days
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
25.0%
1/4 • 90 Days
|
0.00%
0/4 • 90 Days
|
12.5%
1/8 • 90 Days
|
12.5%
1/8 • 90 Days
|
20.0%
2/10 • 90 Days
|
|
Infections and infestations
Otitis media
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/4 • 90 Days
|
12.5%
1/8 • 90 Days
|
0.00%
0/8 • 90 Days
|
0.00%
0/10 • 90 Days
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/8 • 90 Days
|
0.00%
0/8 • 90 Days
|
10.0%
1/10 • 90 Days
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/8 • 90 Days
|
12.5%
1/8 • 90 Days
|
0.00%
0/10 • 90 Days
|
|
Infections and infestations
Skin candida
|
50.0%
1/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/8 • 90 Days
|
0.00%
0/8 • 90 Days
|
0.00%
0/10 • 90 Days
|
|
Infections and infestations
Tinea capitis
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/8 • 90 Days
|
0.00%
0/8 • 90 Days
|
10.0%
1/10 • 90 Days
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/8 • 90 Days
|
12.5%
1/8 • 90 Days
|
10.0%
1/10 • 90 Days
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/8 • 90 Days
|
0.00%
0/8 • 90 Days
|
10.0%
1/10 • 90 Days
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/8 • 90 Days
|
12.5%
1/8 • 90 Days
|
0.00%
0/10 • 90 Days
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/4 • 90 Days
|
12.5%
1/8 • 90 Days
|
0.00%
0/8 • 90 Days
|
0.00%
0/10 • 90 Days
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/4 • 90 Days
|
12.5%
1/8 • 90 Days
|
25.0%
2/8 • 90 Days
|
0.00%
0/10 • 90 Days
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/8 • 90 Days
|
0.00%
0/8 • 90 Days
|
10.0%
1/10 • 90 Days
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
0.00%
0/4 • 90 Days
|
25.0%
1/4 • 90 Days
|
12.5%
1/8 • 90 Days
|
12.5%
1/8 • 90 Days
|
10.0%
1/10 • 90 Days
|
|
Investigations
Blood glucose decreased
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/8 • 90 Days
|
0.00%
0/8 • 90 Days
|
10.0%
1/10 • 90 Days
|
|
Investigations
Blood glucose increased
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/8 • 90 Days
|
12.5%
1/8 • 90 Days
|
30.0%
3/10 • 90 Days
|
|
Investigations
Blood potassium decreased
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/8 • 90 Days
|
0.00%
0/8 • 90 Days
|
10.0%
1/10 • 90 Days
|
|
Investigations
Blood sodium decreased
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
25.0%
1/4 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/8 • 90 Days
|
0.00%
0/8 • 90 Days
|
0.00%
0/10 • 90 Days
|
|
Investigations
Weight decreased
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/8 • 90 Days
|
0.00%
0/8 • 90 Days
|
10.0%
1/10 • 90 Days
|
|
Investigations
White blood cells urine positive
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/8 • 90 Days
|
0.00%
0/8 • 90 Days
|
10.0%
1/10 • 90 Days
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/8 • 90 Days
|
0.00%
0/8 • 90 Days
|
10.0%
1/10 • 90 Days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • 90 Days
|
50.0%
1/2 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/8 • 90 Days
|
0.00%
0/8 • 90 Days
|
10.0%
1/10 • 90 Days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/8 • 90 Days
|
0.00%
0/8 • 90 Days
|
10.0%
1/10 • 90 Days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/4 • 90 Days
|
12.5%
1/8 • 90 Days
|
0.00%
0/8 • 90 Days
|
0.00%
0/10 • 90 Days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
0.00%
0/4 • 90 Days
|
25.0%
1/4 • 90 Days
|
25.0%
2/8 • 90 Days
|
0.00%
0/8 • 90 Days
|
10.0%
1/10 • 90 Days
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • 90 Days
|
50.0%
1/2 • 90 Days
|
25.0%
1/4 • 90 Days
|
50.0%
2/4 • 90 Days
|
12.5%
1/8 • 90 Days
|
12.5%
1/8 • 90 Days
|
20.0%
2/10 • 90 Days
|
|
Nervous system disorders
Lethargy
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/8 • 90 Days
|
12.5%
1/8 • 90 Days
|
0.00%
0/10 • 90 Days
|
|
Nervous system disorders
Presyncope
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/4 • 90 Days
|
12.5%
1/8 • 90 Days
|
12.5%
1/8 • 90 Days
|
0.00%
0/10 • 90 Days
|
|
Nervous system disorders
Tremor
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/8 • 90 Days
|
12.5%
1/8 • 90 Days
|
0.00%
0/10 • 90 Days
|
|
Psychiatric disorders
Depression
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/8 • 90 Days
|
12.5%
1/8 • 90 Days
|
0.00%
0/10 • 90 Days
|
|
Renal and urinary disorders
Albuminuria
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
25.0%
1/4 • 90 Days
|
0.00%
0/4 • 90 Days
|
25.0%
2/8 • 90 Days
|
25.0%
2/8 • 90 Days
|
20.0%
2/10 • 90 Days
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/8 • 90 Days
|
0.00%
0/8 • 90 Days
|
10.0%
1/10 • 90 Days
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
25.0%
1/4 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/8 • 90 Days
|
0.00%
0/8 • 90 Days
|
0.00%
0/10 • 90 Days
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/8 • 90 Days
|
12.5%
1/8 • 90 Days
|
0.00%
0/10 • 90 Days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/8 • 90 Days
|
12.5%
1/8 • 90 Days
|
0.00%
0/10 • 90 Days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/8 • 90 Days
|
25.0%
2/8 • 90 Days
|
0.00%
0/10 • 90 Days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/4 • 90 Days
|
12.5%
1/8 • 90 Days
|
0.00%
0/8 • 90 Days
|
10.0%
1/10 • 90 Days
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/4 • 90 Days
|
25.0%
2/8 • 90 Days
|
0.00%
0/8 • 90 Days
|
10.0%
1/10 • 90 Days
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/8 • 90 Days
|
0.00%
0/8 • 90 Days
|
10.0%
1/10 • 90 Days
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/8 • 90 Days
|
12.5%
1/8 • 90 Days
|
0.00%
0/10 • 90 Days
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • 90 Days
|
0.00%
0/2 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/4 • 90 Days
|
0.00%
0/8 • 90 Days
|
12.5%
1/8 • 90 Days
|
10.0%
1/10 • 90 Days
|
Additional Information
Davey, Richard
National Institute of Allergy and Infectious Diseases
Phone: +1 301 496 8029
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place