Trial Outcomes & Findings for A Dose Ascending Study to Evaluate the Safety of NH002 as a Contrast Agent in Cardiac Echocardiography (NCT NCT04185246)
NCT ID: NCT04185246
Last Updated: 2025-11-18
Results Overview
Standard 12-lead ECGs will be assessed from pre-injection to 60 minutes post-injection for changes in QT/ corrected QT(QTc) interval (in ms) and ECG morphology; each standard 12-lead ECG assessment will be scored as either normal or abnormal
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
36 participants
Primary outcome timeframe
From pre-injection to 60 minutes post injection
Results posted on
2025-11-18
Participant Flow
Participant milestones
| Measure |
Cohort 1
Subjects will be enrolled with the following intravenous (IV) doses of NH002: 2.5 µl/kg.
Each patient will undergo an unenhanced ultrasound examination and a NH002 contrast-enhanced examination on the same day
|
Cohort 2
Subjects will be enrolled with the following intravenous (IV) doses of NH002: 5.0 µl/kg.
Each patient will undergo an unenhanced ultrasound examination and a NH002 contrast-enhanced examination on the same day
|
Cohort 3
Subjects will be enrolled with the following intravenous (IV) doses of NH002: 10.0 µl/kg.
Each patient will undergo an unenhanced ultrasound examination and a NH002 contrast-enhanced examination on the same day
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Dose Ascending Study to Evaluate the Safety of NH002 as a Contrast Agent in Cardiac Echocardiography
Baseline characteristics by cohort
| Measure |
Cohort 1
n=12 Participants
Participants received single intravenous bolus injection dose of NH002 2.5 µl/kg.
|
Cohort 2
n=12 Participants
Participants received single intravenous bolus injection dose of NH002 5.0 µl/kg.
|
Cohort 3
n=12 Participants
Participants received single intravenous bolus injection dose of NH002 10.0 µl/kg.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43.5 years
STANDARD_DEVIATION 14.77 • n=39 Participants
|
38.8 years
STANDARD_DEVIATION 10.29 • n=29 Participants
|
36.8 years
STANDARD_DEVIATION 11.42 • n=60 Participants
|
39.7 years
STANDARD_DEVIATION 12.29 • n=185 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=39 Participants
|
7 Participants
n=29 Participants
|
6 Participants
n=60 Participants
|
17 Participants
n=185 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=39 Participants
|
5 Participants
n=29 Participants
|
6 Participants
n=60 Participants
|
19 Participants
n=185 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=185 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=39 Participants
|
12 Participants
n=29 Participants
|
12 Participants
n=60 Participants
|
36 Participants
n=185 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=185 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=185 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=185 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=185 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=29 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=185 Participants
|
|
Height
|
168.4 centimeter
STANDARD_DEVIATION 11.396 • n=39 Participants
|
163.7 centimeter
STANDARD_DEVIATION 10.93 • n=29 Participants
|
166.74 centimeter
STANDARD_DEVIATION 11.991 • n=60 Participants
|
166.28 centimeter
STANDARD_DEVIATION 11.29 • n=185 Participants
|
|
Weight
|
76.88 kilogram
STANDARD_DEVIATION 21.992 • n=39 Participants
|
63.17 kilogram
STANDARD_DEVIATION 13.131 • n=29 Participants
|
73.59 kilogram
STANDARD_DEVIATION 22.279 • n=60 Participants
|
71.21 kilogram
STANDARD_DEVIATION 19.933 • n=185 Participants
|
PRIMARY outcome
Timeframe: From pre-injection to 60 minutes post injectionPopulation: All abnormal findings of 12-lead ECG interpretations after dosing were assessed as non-clinically significant and not related to NH002.
Standard 12-lead ECGs will be assessed from pre-injection to 60 minutes post-injection for changes in QT/ corrected QT(QTc) interval (in ms) and ECG morphology; each standard 12-lead ECG assessment will be scored as either normal or abnormal
Outcome measures
| Measure |
Cohort 3
n=12 Participants
Participants received single intravenous bolus injection dose of NH002 10.0 µl/kg.
|
Cohort 1
n=12 Participants
Participants received single intravenous bolus injection dose of NH002 2.5 µl/kg.
|
Cohort 2
n=12 Participants
Participants received single intravenous bolus injection dose of NH002 5.0 µl/kg.
|
|---|---|---|---|
|
12-lead ECGs
Change of Baseline (QT) at 10 minutes post-dose
|
6.8 millisecond
Standard Deviation 17.65
|
2.8 millisecond
Standard Deviation 13.65
|
-6.0 millisecond
Standard Deviation 13.16
|
|
12-lead ECGs
Change of Baseline (QT) at 30 minutes post-dose
|
16.0 millisecond
Standard Deviation 13.4
|
10.8 millisecond
Standard Deviation 13.28
|
6.0 millisecond
Standard Deviation 12.59
|
|
12-lead ECGs
Change of Baseline (QT) at 60 minutes post-dose
|
10.6 millisecond
Standard Deviation 9.59
|
7.1 millisecond
Standard Deviation 17.17
|
3.4 millisecond
Standard Deviation 17.17
|
|
12-lead ECGs
Baseline (QTc)
|
404.6 millisecond
Standard Deviation 15.32
|
415.1 millisecond
Standard Deviation 21.71
|
415.9 millisecond
Standard Deviation 20.38
|
|
12-lead ECGs
Change of baseline (QTc) at 10 minutes post-dose
|
7.8 millisecond
Standard Deviation 7.7
|
1.3 millisecond
Standard Deviation 13.92
|
-6.4 millisecond
Standard Deviation 10.95
|
|
12-lead ECGs
Change of baseline (QTc) at 30 minutes post-dose
|
8.8 millisecond
Standard Deviation 9.17
|
0.4 millisecond
Standard Deviation 14.25
|
-1.3 millisecond
Standard Deviation 12.14
|
|
12-lead ECGs
Change of baseline (QTc) at 60 minutes post-dose
|
6.9 millisecond
Standard Deviation 5.88
|
-0.1 millisecond
Standard Deviation 13.03
|
-3.0 millisecond
Standard Deviation 11.96
|
|
12-lead ECGs
Baseline (QT)
|
386.3 millisecond
Standard Deviation 25.99
|
393.9 millisecond
Standard Deviation 19.37
|
392.0 millisecond
Standard Deviation 24.07
|
PRIMARY outcome
Timeframe: From pre-injection to 120 minutes post injectionMonitor for any changes in body temperature (in Celsius degree)
Outcome measures
| Measure |
Cohort 3
n=12 Participants
Participants received single intravenous bolus injection dose of NH002 10.0 µl/kg.
|
Cohort 1
n=12 Participants
Participants received single intravenous bolus injection dose of NH002 2.5 µl/kg.
|
Cohort 2
n=12 Participants
Participants received single intravenous bolus injection dose of NH002 5.0 µl/kg.
|
|---|---|---|---|
|
Body Temperature
Baseline
|
36.76 Celsius degree
Standard Deviation 0.385
|
36.76 Celsius degree
Standard Deviation 0.294
|
36.73 Celsius degree
Standard Deviation 0.306
|
|
Body Temperature
Change from baseline at 5 minutes post-dose
|
-0.01 Celsius degree
Standard Deviation 0.268
|
-0.01 Celsius degree
Standard Deviation 0.215
|
-0.02 Celsius degree
Standard Deviation 0.195
|
|
Body Temperature
Change from baseline at 10 minutes post-dose
|
-0.06 Celsius degree
Standard Deviation 0.207
|
-0.01 Celsius degree
Standard Deviation 0.312
|
0.07 Celsius degree
Standard Deviation 0.235
|
|
Body Temperature
Change from baseline at 30 minutes post-dose
|
0 Celsius degree
Standard Deviation 0.2
|
-0.07 Celsius degree
Standard Deviation 0.328
|
0.11 Celsius degree
Standard Deviation 0.215
|
|
Body Temperature
Change from baseline at 60 minutes post-dose
|
-0.18 Celsius degree
Standard Deviation 0.313
|
-0.08 Celsius degree
Standard Deviation 0.457
|
0.05 Celsius degree
Standard Deviation 0.271
|
|
Body Temperature
Change from baseline at 120 minutes post-dose
|
-0.02 Celsius degree
Standard Deviation 0.518
|
-0.07 Celsius degree
Standard Deviation 0.442
|
0.1 Celsius degree
Standard Deviation 0.283
|
PRIMARY outcome
Timeframe: From pre-injection to 120 minutes post injectionMonitor for any changes in heart rate (in beats/min)
Outcome measures
| Measure |
Cohort 3
n=12 Participants
Participants received single intravenous bolus injection dose of NH002 10.0 µl/kg.
|
Cohort 1
n=12 Participants
Participants received single intravenous bolus injection dose of NH002 2.5 µl/kg.
|
Cohort 2
n=12 Participants
Participants received single intravenous bolus injection dose of NH002 5.0 µl/kg.
|
|---|---|---|---|
|
Heart Rate
Baseline
|
69.0 beats/minute
Standard Deviation 8.06
|
70.1 beats/minute
Standard Deviation 9.93
|
71.3 beats/minute
Standard Deviation 7.73
|
|
Heart Rate
Change from baseline at 10 minutes post-dose
|
-0.1 beats/minute
Standard Deviation 3.73
|
-0.7 beats/minute
Standard Deviation 2.71
|
-0.1 beats/minute
Standard Deviation 5.87
|
|
Heart Rate
Change from baseline at 30 minutes post-dose
|
-0.3 beats/minute
Standard Deviation 6.85
|
-3.0 beats/minute
Standard Deviation 5.34
|
-1.3 beats/minute
Standard Deviation 5.99
|
|
Heart Rate
Change from baseline at 60 minutes post-dose
|
0.7 beats/minute
Standard Deviation 4.56
|
-0.9 beats/minute
Standard Deviation 5.96
|
-1.2 beats/minute
Standard Deviation 4.37
|
|
Heart Rate
Change from baseline at 120 minutes post-dose
|
8.3 beats/minute
Standard Deviation 9.9
|
4.9 beats/minute
Standard Deviation 10.29
|
6.8 beats/minute
Standard Deviation 12.4
|
PRIMARY outcome
Timeframe: From pre-injection to 120 minutes post injectionMonitor for any changes in respiratory rate (in breaths/min)
Outcome measures
| Measure |
Cohort 3
n=12 Participants
Participants received single intravenous bolus injection dose of NH002 10.0 µl/kg.
|
Cohort 1
n=12 Participants
Participants received single intravenous bolus injection dose of NH002 2.5 µl/kg.
|
Cohort 2
n=12 Participants
Participants received single intravenous bolus injection dose of NH002 5.0 µl/kg.
|
|---|---|---|---|
|
Respiratory Rate
Baseline
|
16.9 breaths/minute
Standard Deviation 4.44
|
15.6 breaths/minute
Standard Deviation 3.55
|
15.1 breaths/minute
Standard Deviation 2.07
|
|
Respiratory Rate
Change from baseline at 10 minutes post-dose
|
-1.4 breaths/minute
Standard Deviation 3.12
|
0.6 breaths/minute
Standard Deviation 3.8
|
-0.6 breaths/minute
Standard Deviation 3.29
|
|
Respiratory Rate
Change from baseline at 30 minutes post-dose
|
-1.3 breaths/minute
Standard Deviation 4.71
|
0.9 breaths/minute
Standard Deviation 3.09
|
-0.8 breaths/minute
Standard Deviation 3.28
|
|
Respiratory Rate
Change from baseline at 60 minutes post-dose
|
-2.3 breaths/minute
Standard Deviation 4.09
|
0.5 breaths/minute
Standard Deviation 3.85
|
-0.9 breaths/minute
Standard Deviation 2.75
|
|
Respiratory Rate
Change from baseline at 120 minutes post-dose
|
-1.3 breaths/minute
Standard Deviation 4.48
|
0.8 breaths/minute
Standard Deviation 3.43
|
-0.5 breaths/minute
Standard Deviation 3.61
|
PRIMARY outcome
Timeframe: From pre-injection to 120 minutes post injectionMonitor for any changes in blood pressure (in mmHg)
Outcome measures
| Measure |
Cohort 3
n=12 Participants
Participants received single intravenous bolus injection dose of NH002 10.0 µl/kg.
|
Cohort 1
n=12 Participants
Participants received single intravenous bolus injection dose of NH002 2.5 µl/kg.
|
Cohort 2
n=12 Participants
Participants received single intravenous bolus injection dose of NH002 5.0 µl/kg.
|
|---|---|---|---|
|
Blood Pressure
Baseline (SBP)
|
112.7 mmHg
Standard Deviation 16.33
|
132.8 mmHg
Standard Deviation 14.93
|
106.8 mmHg
Standard Deviation 15.6
|
|
Blood Pressure
Change from baseline (SBP) at 10 minutes post-dose
|
-0.3 mmHg
Standard Deviation 7.76
|
-2.5 mmHg
Standard Deviation 9.48
|
0.5 mmHg
Standard Deviation 6.45
|
|
Blood Pressure
Change from baseline (SBP) at 30 minutes post-dose
|
4.1 mmHg
Standard Deviation 9.46
|
-5.2 mmHg
Standard Deviation 11.54
|
4.8 mmHg
Standard Deviation 13.33
|
|
Blood Pressure
Change from baseline (SBP) at 60 minutes post-dose
|
6.0 mmHg
Standard Deviation 10.44
|
-4.8 mmHg
Standard Deviation 15.03
|
1.5 mmHg
Standard Deviation 12.59
|
|
Blood Pressure
Change from baseline (SBP) at 120 minutes post-dose
|
13.8 mmHg
Standard Deviation 19.6
|
-4.0 mmHg
Standard Deviation 13.1
|
7.6 mmHg
Standard Deviation 15.47
|
|
Blood Pressure
Baseline (DBP)
|
71.5 mmHg
Standard Deviation 11.76
|
85.2 mmHg
Standard Deviation 11.61
|
68.5 mmHg
Standard Deviation 13.3
|
|
Blood Pressure
Change from baseline (DBP) at 10 minutes post-dose
|
2.6 mmHg
Standard Deviation 5.96
|
-2.6 mmHg
Standard Deviation 6.56
|
0 mmHg
Standard Deviation 4.92
|
|
Blood Pressure
Change from baseline (DBP) at 30 minutes post-dose
|
3.1 mmHg
Standard Deviation 9.6
|
-3.9 mmHg
Standard Deviation 8.12
|
4.1 mmHg
Standard Deviation 10.66
|
|
Blood Pressure
Change from baseline (DBP) at 60 minutes post-dose
|
7.8 mmHg
Standard Deviation 11.58
|
-3.0 mmHg
Standard Deviation 10.4
|
3.6 mmHg
Standard Deviation 11.52
|
|
Blood Pressure
Change from baseline (DBP) at 120 minutes post-dose
|
8.7 mmHg
Standard Deviation 14.5
|
-2.3 mmHg
Standard Deviation 7.94
|
6.8 mmHg
Standard Deviation 14.16
|
PRIMARY outcome
Timeframe: From pre-injection to 240 minutes post-injectionPopulation: The total number of subjects in cohort 2 who underwent TT testing was 11.
Monitor for any changes in TT and aPTT
Outcome measures
| Measure |
Cohort 3
n=12 Participants
Participants received single intravenous bolus injection dose of NH002 10.0 µl/kg.
|
Cohort 1
n=12 Participants
Participants received single intravenous bolus injection dose of NH002 2.5 µl/kg.
|
Cohort 2
n=12 Participants
Participants received single intravenous bolus injection dose of NH002 5.0 µl/kg.
|
|---|---|---|---|
|
Thrombin Time (TT) and Activated Partial Thromboplastin Time (aPTT)
Baseline (TT)
|
16.7 seconds
Standard Deviation 1.836
|
18.6 seconds
Standard Deviation 3.145
|
17.81 seconds
Standard Deviation 0.667
|
|
Thrombin Time (TT) and Activated Partial Thromboplastin Time (aPTT)
Change from baseline (TT) at 60 minutes post-dose
|
-0.24 seconds
Standard Deviation 0.724
|
0.22 seconds
Standard Deviation 0.395
|
-0.12 seconds
Standard Deviation 0.387
|
|
Thrombin Time (TT) and Activated Partial Thromboplastin Time (aPTT)
Change from baseline (TT) at 120 minutes post-dose
|
-0.3 seconds
Standard Deviation 0.662
|
0.06 seconds
Standard Deviation 0.528
|
0.05 seconds
Standard Deviation 0.95
|
|
Thrombin Time (TT) and Activated Partial Thromboplastin Time (aPTT)
Change from baseline (TT) at 240 minutes post-dose
|
0.31 seconds
Standard Deviation 1.274
|
0.11 seconds
Standard Deviation 0.497
|
-0.05 seconds
Standard Deviation 0.62
|
|
Thrombin Time (TT) and Activated Partial Thromboplastin Time (aPTT)
Baseline (APTT)
|
28.87 seconds
Standard Deviation 2.796
|
31.54 seconds
Standard Deviation 3.888
|
28.76 seconds
Standard Deviation 27.81
|
|
Thrombin Time (TT) and Activated Partial Thromboplastin Time (aPTT)
Change from baseline (APTT) at 60 minutes post-dose
|
-0.8 seconds
Standard Deviation 2.921
|
-0.3 seconds
Standard Deviation 2.625
|
-1.05 seconds
Standard Deviation 2.184
|
|
Thrombin Time (TT) and Activated Partial Thromboplastin Time (aPTT)
Change from baseline (APTT) at 120 minutes post-dose
|
-0.61 seconds
Standard Deviation 2.586
|
-0.49 seconds
Standard Deviation 3.11
|
-0.48 seconds
Standard Deviation 1.788
|
|
Thrombin Time (TT) and Activated Partial Thromboplastin Time (aPTT)
Change from baseline (APTT) at 240 minutes post-dose
|
-1.5 seconds
Standard Deviation 2.375
|
-0.55 seconds
Standard Deviation 3.191
|
-0.68 seconds
Standard Deviation 1.516
|
PRIMARY outcome
Timeframe: pre-injection and 240 minutes post-injectionPopulation: Troponin I was utilized at site 102. The sample sizes were 5, 7, and 7 for cohorts 1, 2, and 3, respectively.
Monitor for any changes in Cardiac troponin I
Outcome measures
| Measure |
Cohort 3
n=7 Participants
Participants received single intravenous bolus injection dose of NH002 10.0 µl/kg.
|
Cohort 1
n=5 Participants
Participants received single intravenous bolus injection dose of NH002 2.5 µl/kg.
|
Cohort 2
n=7 Participants
Participants received single intravenous bolus injection dose of NH002 5.0 µl/kg.
|
|---|---|---|---|
|
Cardiac Troponin I
Baseline (troponin I)
|
0.005 ng/mL
Standard Deviation 0.000
|
0.005 ng/mL
Standard Deviation 0.000
|
0.005 ng/mL
Standard Deviation 0.000
|
|
Cardiac Troponin I
240 minutes after dosing (troponin I)
|
0.005 ng/mL
Standard Deviation 0.000
|
0.005 ng/mL
Standard Deviation 0.000
|
0.005 ng/mL
Standard Deviation 0.000
|
|
Cardiac Troponin I
Change from baseline (troponin I) at 240 minutes post-dose
|
0.000 ng/mL
Standard Deviation 0.000
|
0.000 ng/mL
Standard Deviation 0.000
|
0.000 ng/mL
Standard Deviation 0.000
|
PRIMARY outcome
Timeframe: From pre-injection to 120 minutes post-injectionMonitor for any changes in SpO2
Outcome measures
| Measure |
Cohort 3
n=12 Participants
Participants received single intravenous bolus injection dose of NH002 10.0 µl/kg.
|
Cohort 1
n=12 Participants
Participants received single intravenous bolus injection dose of NH002 2.5 µl/kg.
|
Cohort 2
n=12 Participants
Participants received single intravenous bolus injection dose of NH002 5.0 µl/kg.
|
|---|---|---|---|
|
Oxygen Saturation by Pulse Oximetry (SpO2)
Baseline
|
98.3 percentage
Standard Deviation 1.14
|
98.8 percentage
Standard Deviation 1.06
|
98.9 percentage
Standard Deviation 1.51
|
|
Oxygen Saturation by Pulse Oximetry (SpO2)
Change from baseline at 10 minutes post-dose
|
-0.4 percentage
Standard Deviation 1.38
|
0.4 percentage
Standard Deviation 1.31
|
0.3 percentage
Standard Deviation 0.62
|
|
Oxygen Saturation by Pulse Oximetry (SpO2)
Change from baseline at 30 minutes post-dose
|
-0.3 percentage
Standard Deviation 0.87
|
0.2 percentage
Standard Deviation 1.27
|
0.3 percentage
Standard Deviation 1.29
|
|
Oxygen Saturation by Pulse Oximetry (SpO2)
Change from baseline at 60 minutes post-dose
|
0.8 percentage
Standard Deviation 1.22
|
0.5 percentage
Standard Deviation 1.88
|
0.4 percentage
Standard Deviation 1.38
|
|
Oxygen Saturation by Pulse Oximetry (SpO2)
Change from baseline at 120 minutes post-dose
|
0.2 percentage
Standard Deviation 0.94
|
0 percentage
Standard Deviation 1.13
|
-0.2 percentage
Standard Deviation 1.64
|
PRIMARY outcome
Timeframe: From pre-injection to 240 minutes post-injectionPopulation: One subject allergic to the tap (not injection site) at 120 minutes after dosing. It was determined that there was no relationship between the data and the IP.
Monitor for any potential adverse allergic reaction
Outcome measures
| Measure |
Cohort 3
n=12 Participants
Participants received single intravenous bolus injection dose of NH002 10.0 µl/kg.
|
Cohort 1
n=12 Participants
Participants received single intravenous bolus injection dose of NH002 2.5 µl/kg.
|
Cohort 2
n=12 Participants
Participants received single intravenous bolus injection dose of NH002 5.0 µl/kg.
|
|---|---|---|---|
|
Rate of Any Potential Adverse Allergic Reaction
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: pre-injection and 240 minutes post-injectionPopulation: Troponin T was utilized at site 101. The sample sizes were 7, 5, and 5 for cohorts 1, 2, and 3, respectively.
Monitor for any changes in Cardiac troponin T
Outcome measures
| Measure |
Cohort 3
n=5 Participants
Participants received single intravenous bolus injection dose of NH002 10.0 µl/kg.
|
Cohort 1
n=7 Participants
Participants received single intravenous bolus injection dose of NH002 2.5 µl/kg.
|
Cohort 2
n=5 Participants
Participants received single intravenous bolus injection dose of NH002 5.0 µl/kg.
|
|---|---|---|---|
|
Cardiac Troponin T
Baseline (troponin T)
|
4.38 ng/L
Standard Deviation 1.824
|
4.07 ng/L
Standard Deviation 2.53
|
1.5 ng/L
Standard Deviation 0.0
|
|
Cardiac Troponin T
240 minutes after dosing (troponin T)
|
5.72 ng/L
Standard Deviation 4.387
|
5.21 ng/L
Standard Deviation 1.368
|
2.3 ng/L
Standard Deviation 1.105
|
|
Cardiac Troponin T
Change from baseline (troponin T) at 240 minutes post-dose
|
1.34 ng/L
Standard Deviation 3.833
|
1.14 ng/L
Standard Deviation 1.878
|
0.8 ng/L
Standard Deviation 1.105
|
SECONDARY outcome
Timeframe: Image data obtained pre-injection and within 10 minutes post-injectionThe percentage of subjects with moderate or complete left ventricular opacification (LVO), defined by an LVO grade of 2 (moderate) or 3 (complete), as assessed by the blinded central reader(s). The percentage of subjects with complete LVO, defined by an LVO grade of 3 (complete), as assessed by the blinded central reader(s)
Outcome measures
| Measure |
Cohort 3
n=12 Participants
Participants received single intravenous bolus injection dose of NH002 10.0 µl/kg.
|
Cohort 1
n=12 Participants
Participants received single intravenous bolus injection dose of NH002 2.5 µl/kg.
|
Cohort 2
n=12 Participants
Participants received single intravenous bolus injection dose of NH002 5.0 µl/kg.
|
|---|---|---|---|
|
Left Ventricular Opacification (LVO)
LVO grade of 2 (moderate) or 3 (complete)
|
12 Participants
|
12 Participants
|
12 Participants
|
|
Left Ventricular Opacification (LVO)
LVO grade of 3 (complete)
|
12 Participants
|
11 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Image data obtained pre-injection and within 10 minutes post-injectionPopulation: There were 9, 10, and 9 subjects with suboptimal baseline values in cohorts 1, 2, and 3, respectively.
The change from baseline on the left ventricular endocardial border delineation (LVEBD) score, defined using a standard 12-segment model, as assessed by the blinded central reader(s). The left ventricular (LV) endocardium of the 4- or 2- chamber apical views are divided into 6 segments, with 2 basal, mid- and apical segments in each view. For each segment, LVEBD is graded as follows: 0= inadequate border (border not visible); 1= sufficient (border barely visible); 2= good (border clearly visible). A total delineation score (0-24) is obtained by adding the scores from the 6 individual segments in each of the 2 views. The changes from baseline on LVEBD score of subjects with suboptimal LVEBD at baseline, as defined by 2 or more contiguous segments of 6 segments that cannot be visualized reliably in either the apical 4 and/or the 2-chamber view, as assessed by the blinded central reader(s)
Outcome measures
| Measure |
Cohort 3
n=12 Participants
Participants received single intravenous bolus injection dose of NH002 10.0 µl/kg.
|
Cohort 1
n=12 Participants
Participants received single intravenous bolus injection dose of NH002 2.5 µl/kg.
|
Cohort 2
n=12 Participants
Participants received single intravenous bolus injection dose of NH002 5.0 µl/kg.
|
|---|---|---|---|
|
Left Ventricular Endocardial Border Delineation (LVEBD)
LVEBD scores_Baseline (all subjects)
|
9.7 score on a scale
Standard Deviation 6.68
|
11.5 score on a scale
Standard Deviation 6.75
|
8.9 score on a scale
Standard Deviation 4.89
|
|
Left Ventricular Endocardial Border Delineation (LVEBD)
LVEBD scores_Post-dose (all subjects)
|
23.9 score on a scale
Standard Deviation 0.29
|
23.0 score on a scale
Standard Deviation 3.46
|
23.8 score on a scale
Standard Deviation 0.62
|
|
Left Ventricular Endocardial Border Delineation (LVEBD)
Change from baseline (all subjects)
|
14.3 score on a scale
Standard Deviation 6.59
|
11.5 score on a scale
Standard Deviation 7.22
|
14.8 score on a scale
Standard Deviation 4.71
|
|
Left Ventricular Endocardial Border Delineation (LVEBD)
LVEBD scores_Baseline (subjects with suboptimal LVEBD at baseline)
|
7.8 score on a scale
Standard Deviation 6.65
|
8.6 score on a scale
Standard Deviation 4.48
|
7.4 score on a scale
Standard Deviation 3.72
|
|
Left Ventricular Endocardial Border Delineation (LVEBD)
LVEBD scores_Post-dose (subjects with suboptimal LVEBD at baseline)
|
23.9 score on a scale
Standard Deviation 0.33
|
22.7 score on a scale
Standard Deviation 4.0
|
23.7 score on a scale
Standard Deviation 0.67
|
|
Left Ventricular Endocardial Border Delineation (LVEBD)
Change from baseline (subjects with suboptimal LVEBD at baseline)
|
16.1 score on a scale
Standard Deviation 6.57
|
14.1 score on a scale
Standard Deviation 6.11
|
16.3 score on a scale
Standard Deviation 3.56
|
SECONDARY outcome
Timeframe: Image data obtained pre-injection and within 10 minutes post-injectionA duration of clinically useful contrast calculated by measuring the time between the disappearance of shadowing effect (useful effect starts) and the time when moderate or full LV enhancement and contrast enhancement are no longer adequate (useful effect ends), as assessed by the blinded central reader(s)
Outcome measures
| Measure |
Cohort 3
n=12 Participants
Participants received single intravenous bolus injection dose of NH002 10.0 µl/kg.
|
Cohort 1
n=12 Participants
Participants received single intravenous bolus injection dose of NH002 2.5 µl/kg.
|
Cohort 2
n=12 Participants
Participants received single intravenous bolus injection dose of NH002 5.0 µl/kg.
|
|---|---|---|---|
|
Duration of Clinically Useful Contrast
|
3.59 minutes
Standard Deviation 1.854
|
7.2 minutes
Standard Deviation 2.458
|
7.67 minutes
Standard Deviation 1.684
|
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: 2 other events
Deaths: 0 deaths
Cohort 3
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1
n=12 participants at risk
Participants received single intravenous bolus injection dose of NH002 2.5 µl/kg.
|
Cohort 2
n=12 participants at risk
Participants received single intravenous bolus injection dose of NH002 5.0 µl/kg.
|
Cohort 3
n=12 participants at risk
Participants received single intravenous bolus injection dose of NH002 10.0 µl/kg.
|
|---|---|---|---|
|
General disorders
Chest discomfort
|
0.00%
0/12 • Each subject had to be carefully monitored for the development of any AEs throughout the study from the signing of the informed consent form to 7 days after receipt of the dose of study agent.
|
0.00%
0/12 • Each subject had to be carefully monitored for the development of any AEs throughout the study from the signing of the informed consent form to 7 days after receipt of the dose of study agent.
|
16.7%
2/12 • Number of events 2 • Each subject had to be carefully monitored for the development of any AEs throughout the study from the signing of the informed consent form to 7 days after receipt of the dose of study agent.
|
|
General disorders
Chest pain
|
0.00%
0/12 • Each subject had to be carefully monitored for the development of any AEs throughout the study from the signing of the informed consent form to 7 days after receipt of the dose of study agent.
|
8.3%
1/12 • Number of events 1 • Each subject had to be carefully monitored for the development of any AEs throughout the study from the signing of the informed consent form to 7 days after receipt of the dose of study agent.
|
8.3%
1/12 • Number of events 1 • Each subject had to be carefully monitored for the development of any AEs throughout the study from the signing of the informed consent form to 7 days after receipt of the dose of study agent.
|
|
General disorders
Chills
|
0.00%
0/12 • Each subject had to be carefully monitored for the development of any AEs throughout the study from the signing of the informed consent form to 7 days after receipt of the dose of study agent.
|
0.00%
0/12 • Each subject had to be carefully monitored for the development of any AEs throughout the study from the signing of the informed consent form to 7 days after receipt of the dose of study agent.
|
8.3%
1/12 • Number of events 1 • Each subject had to be carefully monitored for the development of any AEs throughout the study from the signing of the informed consent form to 7 days after receipt of the dose of study agent.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • Each subject had to be carefully monitored for the development of any AEs throughout the study from the signing of the informed consent form to 7 days after receipt of the dose of study agent.
|
0.00%
0/12 • Each subject had to be carefully monitored for the development of any AEs throughout the study from the signing of the informed consent form to 7 days after receipt of the dose of study agent.
|
25.0%
3/12 • Number of events 3 • Each subject had to be carefully monitored for the development of any AEs throughout the study from the signing of the informed consent form to 7 days after receipt of the dose of study agent.
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/12 • Each subject had to be carefully monitored for the development of any AEs throughout the study from the signing of the informed consent form to 7 days after receipt of the dose of study agent.
|
0.00%
0/12 • Each subject had to be carefully monitored for the development of any AEs throughout the study from the signing of the informed consent form to 7 days after receipt of the dose of study agent.
|
8.3%
1/12 • Number of events 1 • Each subject had to be carefully monitored for the development of any AEs throughout the study from the signing of the informed consent form to 7 days after receipt of the dose of study agent.
|
|
Nervous system disorders
Headache
|
0.00%
0/12 • Each subject had to be carefully monitored for the development of any AEs throughout the study from the signing of the informed consent form to 7 days after receipt of the dose of study agent.
|
0.00%
0/12 • Each subject had to be carefully monitored for the development of any AEs throughout the study from the signing of the informed consent form to 7 days after receipt of the dose of study agent.
|
8.3%
1/12 • Number of events 1 • Each subject had to be carefully monitored for the development of any AEs throughout the study from the signing of the informed consent form to 7 days after receipt of the dose of study agent.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/12 • Each subject had to be carefully monitored for the development of any AEs throughout the study from the signing of the informed consent form to 7 days after receipt of the dose of study agent.
|
8.3%
1/12 • Number of events 1 • Each subject had to be carefully monitored for the development of any AEs throughout the study from the signing of the informed consent form to 7 days after receipt of the dose of study agent.
|
16.7%
2/12 • Number of events 2 • Each subject had to be carefully monitored for the development of any AEs throughout the study from the signing of the informed consent form to 7 days after receipt of the dose of study agent.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/12 • Each subject had to be carefully monitored for the development of any AEs throughout the study from the signing of the informed consent form to 7 days after receipt of the dose of study agent.
|
8.3%
1/12 • Number of events 1 • Each subject had to be carefully monitored for the development of any AEs throughout the study from the signing of the informed consent form to 7 days after receipt of the dose of study agent.
|
8.3%
1/12 • Number of events 1 • Each subject had to be carefully monitored for the development of any AEs throughout the study from the signing of the informed consent form to 7 days after receipt of the dose of study agent.
|
|
Vascular disorders
Flushing
|
0.00%
0/12 • Each subject had to be carefully monitored for the development of any AEs throughout the study from the signing of the informed consent form to 7 days after receipt of the dose of study agent.
|
0.00%
0/12 • Each subject had to be carefully monitored for the development of any AEs throughout the study from the signing of the informed consent form to 7 days after receipt of the dose of study agent.
|
16.7%
2/12 • Number of events 2 • Each subject had to be carefully monitored for the development of any AEs throughout the study from the signing of the informed consent form to 7 days after receipt of the dose of study agent.
|
|
Vascular disorders
Hot flush
|
0.00%
0/12 • Each subject had to be carefully monitored for the development of any AEs throughout the study from the signing of the informed consent form to 7 days after receipt of the dose of study agent.
|
8.3%
1/12 • Number of events 1 • Each subject had to be carefully monitored for the development of any AEs throughout the study from the signing of the informed consent form to 7 days after receipt of the dose of study agent.
|
8.3%
1/12 • Number of events 1 • Each subject had to be carefully monitored for the development of any AEs throughout the study from the signing of the informed consent form to 7 days after receipt of the dose of study agent.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/12 • Each subject had to be carefully monitored for the development of any AEs throughout the study from the signing of the informed consent form to 7 days after receipt of the dose of study agent.
|
0.00%
0/12 • Each subject had to be carefully monitored for the development of any AEs throughout the study from the signing of the informed consent form to 7 days after receipt of the dose of study agent.
|
16.7%
2/12 • Number of events 2 • Each subject had to be carefully monitored for the development of any AEs throughout the study from the signing of the informed consent form to 7 days after receipt of the dose of study agent.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/12 • Each subject had to be carefully monitored for the development of any AEs throughout the study from the signing of the informed consent form to 7 days after receipt of the dose of study agent.
|
0.00%
0/12 • Each subject had to be carefully monitored for the development of any AEs throughout the study from the signing of the informed consent form to 7 days after receipt of the dose of study agent.
|
16.7%
2/12 • Number of events 2 • Each subject had to be carefully monitored for the development of any AEs throughout the study from the signing of the informed consent form to 7 days after receipt of the dose of study agent.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12 • Each subject had to be carefully monitored for the development of any AEs throughout the study from the signing of the informed consent form to 7 days after receipt of the dose of study agent.
|
0.00%
0/12 • Each subject had to be carefully monitored for the development of any AEs throughout the study from the signing of the informed consent form to 7 days after receipt of the dose of study agent.
|
8.3%
1/12 • Number of events 1 • Each subject had to be carefully monitored for the development of any AEs throughout the study from the signing of the informed consent form to 7 days after receipt of the dose of study agent.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60