Trial Outcomes & Findings for Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ST-2427 (NCT NCT04475198)
NCT ID: NCT04475198
Last Updated: 2023-08-03
Results Overview
For purposes of monitoring safety, treatment-emergent adverse events (AEs) will be graded using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers (FDA 2007) which is appropriate for healthy subjects.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Day 1 through Day 8
Results posted on
2023-08-03
Participant Flow
Participant milestones
| Measure |
Single Ascending Dose: Cohort 1
5 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.
ST-2427: Investigational drug
|
Single Ascending Dose: Cohort 2
10 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.
ST-2427: Investigational drug
|
Single Ascending Dose: Cohort 3
15 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.
ST-2427: Investigational drug
|
Single Ascending Dose: Cohort 4
22 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.
ST-2427: Investigational drug
|
Pooled Placebo
placebo (n=2 per cohort) administered once over a 60-minute intravenous (IV) infusion.
Placebo: 5% Dextrose Injection
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
4
|
4
|
8
|
|
Overall Study
COMPLETED
|
4
|
4
|
4
|
4
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ST-2427
Baseline characteristics by cohort
| Measure |
Single Ascending Dose: Cohort 1
n=4 Participants
5 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.
ST-2427: Investigational drug
|
Single Ascending Dose: Cohort 2
n=4 Participants
10 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.
ST-2427: Investigational drug
|
Single Ascending Dose: Cohort 3
n=4 Participants
15 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.
ST-2427: Investigational drug
|
Single Ascending Dose: Cohort 4
n=4 Participants
22 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.
ST-2427: Investigational drug
|
Pooled Placebo
n=8 Participants
Pooled placebo (n=8) administered once over a 60-minute intravenous (IV) infusion.
Placebo: 5% Dextrose Injection
|
Total
n=24 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=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
24 Participants
n=8 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=8 Participants
|
|
Age, Continuous
|
40.0 years
STANDARD_DEVIATION 6.73 • n=5 Participants
|
49.5 years
STANDARD_DEVIATION 3.42 • n=7 Participants
|
40.0 years
STANDARD_DEVIATION 9.93 • n=5 Participants
|
32.5 years
STANDARD_DEVIATION 13.03 • n=4 Participants
|
43.4 years
STANDARD_DEVIATION 11.13 • n=21 Participants
|
41.5 years
STANDARD_DEVIATION 10.36 • n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
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
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
23 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
|
1 Participants
n=21 Participants
|
1 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
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
10 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 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=8 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
4 participants
n=4 Participants
|
8 participants
n=21 Participants
|
24 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 8For purposes of monitoring safety, treatment-emergent adverse events (AEs) will be graded using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers (FDA 2007) which is appropriate for healthy subjects.
Outcome measures
| Measure |
Single Ascending Dose: Cohort 1
n=4 Participants
5 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.
ST-2427: Investigational drug
|
Single Ascending Dose: Cohort 2
n=4 Participants
10 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.
ST-2427: Investigational drug
|
Single Ascending Dose: Cohort 3
n=4 Participants
15 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.
ST-2427: Investigational drug
|
Single Ascending Dose: Cohort 4
n=4 Participants
22 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.
ST-2427: Investigational drug
|
Pooled Placebo
n=8 Participants
Pooled placebo (n=8) administered once over a 60-minute intravenous (IV) infusion.
Placebo: 5% Dextrose Injection
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events
|
3 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 8Blood pressure, including orthostatic blood pressure (BP; diastolic blood pressure \[DBP\], systolic blood pressure \[SBP\]), will be used to analyze for change from baseline. Adverse events assessed by blood pressure include hypertension and hypotension (MedDRA Preferred Term).
Outcome measures
| Measure |
Single Ascending Dose: Cohort 1
n=4 Participants
5 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.
ST-2427: Investigational drug
|
Single Ascending Dose: Cohort 2
n=4 Participants
10 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.
ST-2427: Investigational drug
|
Single Ascending Dose: Cohort 3
n=4 Participants
15 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.
ST-2427: Investigational drug
|
Single Ascending Dose: Cohort 4
n=4 Participants
22 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.
ST-2427: Investigational drug
|
Pooled Placebo
n=8 Participants
Pooled placebo (n=8) administered once over a 60-minute intravenous (IV) infusion.
Placebo: 5% Dextrose Injection
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events Assessed by Blood Pressure
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 8Cardiodynamic evaluation will be performed to evaluate the treatment effects on heart rate-corrected QT interval using the Fridericia (QTcF) corrections.
Outcome measures
| Measure |
Single Ascending Dose: Cohort 1
n=4 Participants
5 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.
ST-2427: Investigational drug
|
Single Ascending Dose: Cohort 2
n=4 Participants
10 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.
ST-2427: Investigational drug
|
Single Ascending Dose: Cohort 3
n=4 Participants
15 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.
ST-2427: Investigational drug
|
Single Ascending Dose: Cohort 4
n=4 Participants
22 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.
ST-2427: Investigational drug
|
Pooled Placebo
n=8 Participants
Pooled placebo (n=8) administered once over a 60-minute intravenous (IV) infusion.
Placebo: 5% Dextrose Injection
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events Assessed by ECG
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 8Descriptive statistics will be used to evaluate the treatment effects on clinical laboratory assessments including clinical chemistry, hematology, and urinalysis.
Outcome measures
| Measure |
Single Ascending Dose: Cohort 1
n=4 Participants
5 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.
ST-2427: Investigational drug
|
Single Ascending Dose: Cohort 2
n=4 Participants
10 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.
ST-2427: Investigational drug
|
Single Ascending Dose: Cohort 3
n=4 Participants
15 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.
ST-2427: Investigational drug
|
Single Ascending Dose: Cohort 4
n=4 Participants
22 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.
ST-2427: Investigational drug
|
Pooled Placebo
n=8 Participants
Pooled placebo (n=8) administered once over a 60-minute intravenous (IV) infusion.
Placebo: 5% Dextrose Injection
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Events Assessed by Clinical Laboratory Assessments
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 8Body weight (kg) will be assessed for changes relative to baseline.
Outcome measures
| Measure |
Single Ascending Dose: Cohort 1
n=4 Participants
5 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.
ST-2427: Investigational drug
|
Single Ascending Dose: Cohort 2
n=4 Participants
10 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.
ST-2427: Investigational drug
|
Single Ascending Dose: Cohort 3
n=4 Participants
15 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.
ST-2427: Investigational drug
|
Single Ascending Dose: Cohort 4
n=4 Participants
22 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.
ST-2427: Investigational drug
|
Pooled Placebo
n=8 Participants
Pooled placebo (n=8) administered once over a 60-minute intravenous (IV) infusion.
Placebo: 5% Dextrose Injection
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events Assessed by Body Weight
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 0-48 hoursPK modeling will be performed using compartmental methods. The maximum concentration of ST-2427 in whole blood after the ST-2427 infusion in the SAD.
Outcome measures
| Measure |
Single Ascending Dose: Cohort 1
n=4 Participants
5 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.
ST-2427: Investigational drug
|
Single Ascending Dose: Cohort 2
n=4 Participants
10 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.
ST-2427: Investigational drug
|
Single Ascending Dose: Cohort 3
n=4 Participants
15 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.
ST-2427: Investigational drug
|
Single Ascending Dose: Cohort 4
n=4 Participants
22 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.
ST-2427: Investigational drug
|
Pooled Placebo
Pooled placebo (n=8) administered once over a 60-minute intravenous (IV) infusion.
Placebo: 5% Dextrose Injection
|
|---|---|---|---|---|---|
|
Pharmacokinetics of ST-2427 Concentration in Whole Blood: Cmax
|
206 ng/mL
Standard Deviation 26.6
|
364 ng/mL
Standard Deviation 51.0
|
551 ng/mL
Standard Deviation 131
|
860 ng/mL
Standard Deviation 226
|
—
|
SECONDARY outcome
Timeframe: 0-9 hoursPK modeling will be performed using compartmental methods. The AUC (area under the curve) of ST-2427 in whole blood after the ST-2427 infusion in the SAD.
Outcome measures
| Measure |
Single Ascending Dose: Cohort 1
n=4 Participants
5 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.
ST-2427: Investigational drug
|
Single Ascending Dose: Cohort 2
n=4 Participants
10 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.
ST-2427: Investigational drug
|
Single Ascending Dose: Cohort 3
n=4 Participants
15 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.
ST-2427: Investigational drug
|
Single Ascending Dose: Cohort 4
n=4 Participants
22 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.
ST-2427: Investigational drug
|
Pooled Placebo
Pooled placebo (n=8) administered once over a 60-minute intravenous (IV) infusion.
Placebo: 5% Dextrose Injection
|
|---|---|---|---|---|---|
|
Pharmacokinetics of ST-2427 Concentration in Whole Blood: Area Under the Curve
|
706 ng*h/mL
Standard Deviation 111
|
1257 ng*h/mL
Standard Deviation 74.2
|
1990 ng*h/mL
Standard Deviation 132
|
2910 ng*h/mL
Standard Deviation 53.3
|
—
|
SECONDARY outcome
Timeframe: 0-25 hoursPK modeling will be performed using compartmental methods. The AUC (area under the curve) of ST-2427 in whole blood after the ST-2427 infusion in the SAD.
Outcome measures
| Measure |
Single Ascending Dose: Cohort 1
n=4 Participants
5 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.
ST-2427: Investigational drug
|
Single Ascending Dose: Cohort 2
n=4 Participants
10 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.
ST-2427: Investigational drug
|
Single Ascending Dose: Cohort 3
n=4 Participants
15 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.
ST-2427: Investigational drug
|
Single Ascending Dose: Cohort 4
n=4 Participants
22 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.
ST-2427: Investigational drug
|
Pooled Placebo
Pooled placebo (n=8) administered once over a 60-minute intravenous (IV) infusion.
Placebo: 5% Dextrose Injection
|
|---|---|---|---|---|---|
|
Pharmacokinetics of ST-2427 Concentration in Whole Blood: Area Under the Curve
|
1044 ng*h/mL
Standard Deviation 141
|
1864 ng*h/mL
Standard Deviation 80.0
|
3003 ng*h/mL
Standard Deviation 126
|
4312 ng*h/mL
Standard Deviation 660
|
—
|
Adverse Events
Single Ascending Dose: Cohort 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Single Ascending Dose: Cohort 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Single Ascending Dose: Cohort 3
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Single Ascending Dose: Cohort 4
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Pooled Placebo
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 |
Single Ascending Dose: Cohort 1
n=4 participants at risk
5 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.
ST-2427: Investigational drug
|
Single Ascending Dose: Cohort 2
n=4 participants at risk
10 mg ST-2427 (n=4) administered once over a 60-minute intravenous (IV) infusion.
ST-2427: Investigational drug
|
Single Ascending Dose: Cohort 3
n=4 participants at risk
15 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.
ST-2427: Investigational drug
|
Single Ascending Dose: Cohort 4
n=4 participants at risk
22 mg ST-2427 (n=4) or placebo (n=2) administered once over a 60-minute intravenous (IV) infusion.
ST-2427: Investigational drug
|
Pooled Placebo
n=8 participants at risk
Pooled placebo (n=8) administered once over a 60-minute intravenous (IV) infusion.
Placebo: 5% Dextrose Injection
|
|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
25.0%
1/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
25.0%
1/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
0.00%
0/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
0.00%
0/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
0.00%
0/8 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
25.0%
1/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
0.00%
0/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
0.00%
0/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
0.00%
0/8 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
0.00%
0/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
0.00%
0/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
25.0%
1/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
0.00%
0/8 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
|
Gastrointestinal disorders
Dry mouth
|
25.0%
1/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
0.00%
0/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
0.00%
0/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
0.00%
0/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
0.00%
0/8 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
|
Gastrointestinal disorders
Dyspepsia
|
25.0%
1/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
0.00%
0/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
0.00%
0/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
0.00%
0/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
0.00%
0/8 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
25.0%
1/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
0.00%
0/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
0.00%
0/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
0.00%
0/8 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
0.00%
0/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
25.0%
1/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
0.00%
0/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
0.00%
0/8 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
0.00%
0/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
0.00%
0/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
0.00%
0/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
12.5%
1/8 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
0.00%
0/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
25.0%
1/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
0.00%
0/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
0.00%
0/8 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
|
Vascular disorders
Hypotension
|
25.0%
1/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
0.00%
0/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
0.00%
0/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
0.00%
0/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
0.00%
0/8 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
0.00%
0/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
0.00%
0/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
0.00%
0/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
12.5%
1/8 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
|
General disorders
Infusion site erythema
|
0.00%
0/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
0.00%
0/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
25.0%
1/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
0.00%
0/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
0.00%
0/8 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
25.0%
1/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
0.00%
0/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
0.00%
0/4 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
0.00%
0/8 • Day 1 through Day 8
Adverse events were classified by System Organ Class (SOC) and Preferred Term (PT) using the Medical Dictionary for Regulatory Activities (MedDRA), version 23.1.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place