Trial Outcomes & Findings for Safety and Efficacy of Trans Sodium Crocetinate (TSC) in Enhancing Tissue Oxygen Levels in Healthy Volunteers (NCT NCT04808622)
NCT ID: NCT04808622
Last Updated: 2023-07-11
Results Overview
Summary Statistics of tcpO2 Levels (mmHg) Overall Measurements (Median of 4 Sensors) in Healthy Subjects
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, and 60 minutes post-dose
Results posted on
2023-07-11
Participant Flow
Participant milestones
| Measure |
TSC 0.5 mg/kg
TSC 0.5 mg/kg given as a one-time IV bolus injection
Trans-Sodium Crocetinate: TSC given as a one-time IV bolus injection
|
TSC 1.0 mg/kg
TSC 1.0 mg/kg given as a one-time IV bolus injection
Trans-Sodium Crocetinate: TSC given as a one-time IV bolus injection
|
TSC 1.5 mg/kg
TSC 1.5 mg/kg given as a one-time IV bolus injection
Trans-Sodium Crocetinate: TSC given as a one-time IV bolus injection
|
TSC 2.0 mg/kg
TSC 2.0 mg/kg given as a one-time IV bolus injection
Trans-Sodium Crocetinate: TSC given as a one-time IV bolus injection
|
TSC 2.5 mg/kg
TSC 2.5 mg/kg given as a one-time IV bolus injection
Trans-Sodium Crocetinate: TSC given as a one-time IV bolus injection
|
Placebo
7 mL normal saline given as a one-time IV bolus injection
Placebo: Placebo normal saline given as a one-time 7 mL one-time IV bolus injection
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
5
|
5
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
5
|
5
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of Trans Sodium Crocetinate (TSC) in Enhancing Tissue Oxygen Levels in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
TSC 0.5 mg/kg
n=5 Participants
TSC 0.5 mg/kg given as a one-time IV bolus injection
Trans-Sodium Crocetinate: TSC given as a one-time IV bolus injection
|
TSC 1.0 mg/kg
n=5 Participants
TSC 1.0 mg/kg given as a one-time IV bolus injection
Trans-Sodium Crocetinate: TSC given as a one-time IV bolus injection
|
TSC 1.5 mg/kg
n=5 Participants
TSC 1.5 mg/kg given as a one-time IV bolus injection
Trans-Sodium Crocetinate: TSC given as a one-time IV bolus injection
|
TSC 2.0 mg/kg
n=5 Participants
TSC 2.0 mg/kg given as a one-time IV bolus injection
Trans-Sodium Crocetinate: TSC given as a one-time IV bolus injection
|
TSC 2.5 mg/kg
n=5 Participants
TSC 2.5 mg/kg given as a one-time IV bolus injection
Trans-Sodium Crocetinate: TSC given as a one-time IV bolus injection
|
Placebo
n=5 Participants
7 mL normal saline given as a one-time IV bolus injection
Placebo: Placebo normal saline given as a one-time 7 mL one-time IV bolus injection
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
30 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Continuous
|
31.0 years
STANDARD_DEVIATION 10.93 • n=93 Participants
|
37.4 years
STANDARD_DEVIATION 11.44 • n=4 Participants
|
33.0 years
STANDARD_DEVIATION 9.17 • n=27 Participants
|
29.8 years
STANDARD_DEVIATION 5.12 • n=483 Participants
|
40.4 years
STANDARD_DEVIATION 8.41 • n=36 Participants
|
27.0 years
STANDARD_DEVIATION 5.00 • n=10 Participants
|
33.1 years
STANDARD_DEVIATION 9.19 • n=115 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
16 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
26 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
19 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, and 60 minutes post-dosePopulation: One subject from the TSC 2.5 mg/kg cohort was excluded due to subcutaneous injection of TSC.
Summary Statistics of tcpO2 Levels (mmHg) Overall Measurements (Median of 4 Sensors) in Healthy Subjects
Outcome measures
| Measure |
TSC 0.5 mg/kg
n=5 Participants
TSC 0.5 mg/kg given as a one-time IV bolus injection
Trans-Sodium Crocetinate: TSC given as a one-time IV bolus injection
|
TSC 1.0 mg/kg
n=5 Participants
TSC 1.0 mg/kg given as a one-time IV bolus injection
Trans-Sodium Crocetinate: TSC given as a one-time IV bolus injection
|
TSC 1.5 mg/kg
n=5 Participants
TSC 1.5 mg/kg given as a one-time IV bolus injection
Trans-Sodium Crocetinate: TSC given as a one-time IV bolus injection
|
TSC 2.0 mg/kg
n=5 Participants
TSC 2.0 mg/kg given as a one-time IV bolus injection
Trans-Sodium Crocetinate: TSC given as a one-time IV bolus injection
|
TSC 2.5 mg/kg
n=4 Participants
TSC 2.5 mg/kg given as a one-time IV bolus injection
Trans-Sodium Crocetinate: TSC given as a one-time IV bolus injection
|
Placebo
n=5 Participants
Placebo given as a one-time IV bolus injection
|
|---|---|---|---|---|---|---|
|
Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2.
Baseline 0 to 5 Minutes (Period 1)
|
175.3 mmHg
Standard Deviation 65.82
|
153.1 mmHg
Standard Deviation 41.18
|
178.0 mmHg
Standard Deviation 62.28
|
179.9 mmHg
Standard Deviation 44.78
|
162.4 mmHg
Standard Deviation 60.01
|
197.2 mmHg
Standard Deviation 35.64
|
|
Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2.
0 to 5 Minutes (Period 2)
|
165.1 mmHg
Standard Deviation 74.19
|
165.8 mmHg
Standard Deviation 41.36
|
180.0 mmHg
Standard Deviation 46.72
|
203.3 mmHg
Standard Deviation 51.59
|
194.7 mmHg
Standard Deviation 104.76
|
212.2 mmHg
Standard Deviation 42.48
|
|
Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2.
0 to 5 Minutes (Period 2-Period 1)
|
11.2 mmHg
Standard Deviation 18.56
|
5.6 mmHg
Standard Deviation 10.79
|
12.1 mmHg
Standard Deviation 16.57
|
25.8 mmHg
Standard Deviation 20.66
|
36.4 mmHg
Standard Deviation 45.84
|
15.4 mmHg
Standard Deviation 10.74
|
|
Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2.
Baseline 5 to 10 Minutes (Period 1)
|
185.2 mmHg
Standard Deviation 72.12
|
159.4 mmHg
Standard Deviation 40.33
|
179.8 mmHg
Standard Deviation 60.77
|
187.4 mmHg
Standard Deviation 46.58
|
160.1 mmHg
Standard Deviation 53.88
|
201.3 mmHg
Standard Deviation 34.41
|
|
Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2.
5 to 10 Minutes (Period 2)
|
170.0 mmHg
Standard Deviation 77.42
|
159.4 mmHg
Standard Deviation 41.05
|
184.1 mmHg
Standard Deviation 57.54
|
206.9 mmHg
Standard Deviation 52.15
|
194.0 mmHg
Standard Deviation 112.18
|
191.4 mmHg
Standard Deviation 29.89
|
|
Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2.
5 to 10 Minutes (Period 2 - Period 1)
|
9.5 mmHg
Standard Deviation 15.92
|
4.3 mmHg
Standard Deviation 5.10
|
4.4 mmHg
Standard Deviation 4.88
|
23.1 mmHg
Standard Deviation 22.02
|
40.9 mmHg
Standard Deviation 57.17
|
3.9 mmHg
Standard Deviation 8.61
|
|
Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2.
Baseline 10 to 15 Minutes (Period 1)
|
180.0 mmHg
Standard Deviation 80.42
|
160.3 mmHg
Standard Deviation 36.89
|
176.2 mmHg
Standard Deviation 56.77
|
196.6 mmHg
Standard Deviation 48.62
|
162.6 mmHg
Standard Deviation 52.24
|
209.1 mmHg
Standard Deviation 38.36
|
|
Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2.
10 to 15 Minutes (Period 2)
|
170.6 mmHg
Standard Deviation 81.23
|
167.5 mmHg
Standard Deviation 47.82
|
183.9 mmHg
Standard Deviation 48.67
|
201.8 mmHg
Standard Deviation 22.56
|
197.6 mmHg
Standard Deviation 113.49
|
189.5 mmHg
Standard Deviation 33.80
|
|
Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2.
10 to 15 Minutes (Period 2 - Period 1)
|
22.2 mmHg
Standard Deviation 38.11
|
7.9 mmHg
Standard Deviation 12.62
|
13.3 mmHg
Standard Deviation 12.05
|
13.1 mmHg
Standard Deviation 18.02
|
39.1 mmHg
Standard Deviation 62.75
|
2.0 mmHg
Standard Deviation 4.36
|
|
Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2.
Baseline 15 to 20 Minutes (Period 1)
|
178.6 mmHg
Standard Deviation 73.05
|
162.3 mmHg
Standard Deviation 36.34
|
180.7 mmHg
Standard Deviation 64.26
|
200.9 mmHg
Standard Deviation 51.63
|
172.8 mmHg
Standard Deviation 65.31
|
211.9 mmHg
Standard Deviation 38.92
|
|
Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2.
15 to 20 Minutes (Period 2)
|
172.9 mmHg
Standard Deviation 81.80
|
174.8 mmHg
Standard Deviation 51.85
|
184.5 mmHg
Standard Deviation 43.30
|
206.4 mmHg
Standard Deviation 20.96
|
197.8 mmHg
Standard Deviation 110.08
|
191.3 mmHg
Standard Deviation 35.59
|
|
Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2.
15 to 20 Minutes (Period 2 - Period 1)
|
18.6 mmHg
Standard Deviation 34.55
|
16.8 mmHg
Standard Deviation 22.89
|
13.4 mmHg
Standard Deviation 14.46
|
16.4 mmHg
Standard Deviation 17.44
|
29.8 mmHg
Standard Deviation 45.52
|
0.0 mmHg
Standard Deviation 0.00
|
|
Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2.
Baseline 20 to 25 Minutes (Period 1)
|
190.9 mmHg
Standard Deviation 74.50
|
164.8 mmHg
Standard Deviation 29.95
|
173.2 mmHg
Standard Deviation 55.79
|
202.8 mmHg
Standard Deviation 46.65
|
173.4 mmHg
Standard Deviation 64.31
|
216.6 mmHg
Standard Deviation 37.24
|
|
Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2.
20 to 25 Minutes (Period 2)
|
171.0 mmHg
Standard Deviation 82.54
|
180.6 mmHg
Standard Deviation 57.06
|
180.2 mmHg
Standard Deviation 46.04
|
214.4 mmHg
Standard Deviation 41.19
|
204.1 mmHg
Standard Deviation 113.93
|
196.3 mmHg
Standard Deviation 47.51
|
|
Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2.
20 to 25 Minutes (Period 2 - Period 1)
|
11.2 mmHg
Standard Deviation 18.64
|
20.7 mmHg
Standard Deviation 38.43
|
14.8 mmHg
Standard Deviation 14.47
|
16.2 mmHg
Standard Deviation 15.83
|
34.9 mmHg
Standard Deviation 49.62
|
0.0 mmHg
Standard Deviation 0.00
|
|
Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2.
Baseline 25 to 30 Minutes (Period 1)
|
190.5 mmHg
Standard Deviation 78.11
|
166.4 mmHg
Standard Deviation 31.95
|
178.8 mmHg
Standard Deviation 59.96
|
200.8 mmHg
Standard Deviation 44.50
|
180.1 mmHg
Standard Deviation 73.41
|
216.2 mmHg
Standard Deviation 34.75
|
|
Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2.
25 to 30 Minutes (Period 2)
|
171.9 mmHg
Standard Deviation 84.09
|
182.0 mmHg
Standard Deviation 64.23
|
182.0 mmHg
Standard Deviation 44.54
|
202.7 mmHg
Standard Deviation 36.80
|
202.0 mmHg
Standard Deviation 116.66
|
184.8 mmHg
Standard Deviation 48.54
|
|
Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2.
25 to 30 Minutes (Period 2 - Period 1)
|
13.6 mmHg
Standard Deviation 25.57
|
22.1 mmHg
Standard Deviation 44.13
|
10.2 mmHg
Standard Deviation 14.06
|
7.2 mmHg
Standard Deviation 7.91
|
26.1 mmHg
Standard Deviation 42.86
|
0.0 mmHg
Standard Deviation 0.00
|
|
Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2.
Baseline 30 to 35 Minutes (Period 1)
|
184.5 mmHg
Standard Deviation 76.58
|
148.1 mmHg
Standard Deviation 38.63
|
175.8 mmHg
Standard Deviation 64.14
|
212.1 mmHg
Standard Deviation 46.47
|
175.4 mmHg
Standard Deviation 74.39
|
207.9 mmHg
Standard Deviation 27.97
|
|
Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2.
30 to 35 Minutes (Period 2)
|
167.0 mmHg
Standard Deviation 87.89
|
172.4 mmHg
Standard Deviation 51.69
|
176.8 mmHg
Standard Deviation 41.05
|
200.5 mmHg
Standard Deviation 37.18
|
198.0 mmHg
Standard Deviation 117.16
|
186.9 mmHg
Standard Deviation 51.28
|
|
Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2.
30 to 35 Minutes (Period 2 - Period 1)
|
15.4 mmHg
Standard Deviation 32.38
|
17.3 mmHg
Standard Deviation 26.50
|
14.0 mmHg
Standard Deviation 20.96
|
5.9 mmHg
Standard Deviation 11.59
|
26.8 mmHg
Standard Deviation 42.32
|
5.9 mmHg
Standard Deviation 13.08
|
|
Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2.
Baseline 35 to 40 Minutes (Period 1)
|
182.4 mmHg
Standard Deviation 68.80
|
151.5 mmHg
Standard Deviation 37.51
|
175.5 mmHg
Standard Deviation 61.35
|
217.9 mmHg
Standard Deviation 55.35
|
177.8 mmHg
Standard Deviation 73.80
|
217.0 mmHg
Standard Deviation 38.14
|
|
Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2.
35 to 40 Minutes (Period 2)
|
170.3 mmHg
Standard Deviation 93.45
|
180.9 mmHg
Standard Deviation 66.13
|
177.4 mmHg
Standard Deviation 38.83
|
200.3 mmHg
Standard Deviation 40.66
|
200.8 mmHg
Standard Deviation 122.86
|
180.7 mmHg
Standard Deviation 56.25
|
|
Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2.
35 to 40 Minutes (Period 2 - Period 1)
|
12.7 mmHg
Standard Deviation 21.04
|
34.5 mmHg
Standard Deviation 47.14
|
15.6 mmHg
Standard Deviation 15.71
|
4.3 mmHg
Standard Deviation 9.50
|
27.2 mmHg
Standard Deviation 49.34
|
1.2 mmHg
Standard Deviation 2.57
|
|
Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2.
Baseline 40 to 45 Minutes (Period 1)
|
188.5 mmHg
Standard Deviation 63.41
|
141.3 mmHg
Standard Deviation 35.52
|
178.6 mmHg
Standard Deviation 58.66
|
208.2 mmHg
Standard Deviation 61.65
|
181.6 mmHg
Standard Deviation 81.21
|
210.5 mmHg
Standard Deviation 38.04
|
|
Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2.
40 to 45 Minutes (Period 2)
|
176.2 mmHg
Standard Deviation 92.17
|
180.6 mmHg
Standard Deviation 66.93
|
174.3 mmHg
Standard Deviation 35.85
|
209.2 mmHg
Standard Deviation 52.68
|
199.8 mmHg
Standard Deviation 127.19
|
179.0 mmHg
Standard Deviation 58.21
|
|
Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2.
40 to 45 Minutes (Period 2 - Period 1)
|
14.7 mmHg
Standard Deviation 26.44
|
43.5 mmHg
Standard Deviation 70.00
|
14.9 mmHg
Standard Deviation 16.14
|
6.9 mmHg
Standard Deviation 9.61
|
23.6 mmHg
Standard Deviation 45.97
|
0.0 mmHg
Standard Deviation 0.00
|
|
Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2.
Baseline 45 to 50 Minutes (Period 1)
|
181.8 mmHg
Standard Deviation 71.14
|
148.9 mmHg
Standard Deviation 34.66
|
177.1 mmHg
Standard Deviation 61.65
|
208.7 mmHg
Standard Deviation 59.68
|
182.5 mmHg
Standard Deviation 87.39
|
210.0 mmHg
Standard Deviation 38.80
|
|
Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2.
45 to 50 Minutes (Period 2)
|
178.5 mmHg
Standard Deviation 94.21
|
173.4 mmHg
Standard Deviation 58.98
|
170.1 mmHg
Standard Deviation 39.37
|
211.1 mmHg
Standard Deviation 53.79
|
204.6 mmHg
Standard Deviation 119.52
|
177.3 mmHg
Standard Deviation 63.38
|
|
Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2.
45 to 50 Minutes (Period 2 - Period 1)
|
16.6 mmHg
Standard Deviation 28.69
|
27.2 mmHg
Standard Deviation 56.55
|
18.2 mmHg
Standard Deviation 17.92
|
5.7 mmHg
Standard Deviation 12.36
|
24.9 mmHg
Standard Deviation 31.39
|
0.8 mmHg
Standard Deviation 1.79
|
|
Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2.
Baseline 50 to 55 Minutes (Period 1)
|
180.7 mmHg
Standard Deviation 72.77
|
168.9 mmHg
Standard Deviation 49.20
|
181.7 mmHg
Standard Deviation 56.10
|
211.6 mmHg
Standard Deviation 49.69
|
183.3 mmHg
Standard Deviation 97.50
|
200.5 mmHg
Standard Deviation 32.29
|
|
Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2.
50 to 55 Minutes (Period 2)
|
173.2 mmHg
Standard Deviation 91.33
|
174.4 mmHg
Standard Deviation 60.55
|
178.2 mmHg
Standard Deviation 40.18
|
208.1 mmHg
Standard Deviation 50.63
|
203.6 mmHg
Standard Deviation 114.20
|
181.2 mmHg
Standard Deviation 68.49
|
|
Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2.
50 to 55 Minutes (Period 2 - Period 1)
|
10.3 mmHg
Standard Deviation 16.19
|
11.0 mmHg
Standard Deviation 14.14
|
12.8 mmHg
Standard Deviation 12.81
|
3.3 mmHg
Standard Deviation 4.10
|
22.7 mmHg
Standard Deviation 18.62
|
6.6 mmHg
Standard Deviation 14.76
|
|
Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2.
Baseline 55 to 60 Minutes (Period 1)
|
171.9 mmHg
Standard Deviation 70.80
|
160.8 mmHg
Standard Deviation 45.32
|
177.2 mmHg
Standard Deviation 47.41
|
196.9 mmHg
Standard Deviation 43.77
|
179.0 mmHg
Standard Deviation 84.54
|
202.1 mmHg
Standard Deviation 35.29
|
|
Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2.
55 to 60 Minutes (Period 2)
|
172.5 mmHg
Standard Deviation 93.64
|
175.5 mmHg
Standard Deviation 69.98
|
172.1 mmHg
Standard Deviation 42.22
|
209.9 mmHg
Standard Deviation 50.43
|
205.9 mmHg
Standard Deviation 119.43
|
174.7 mmHg
Standard Deviation 65.35
|
|
Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2.
55 to 60 Minutes (Period 2 - Period 1)
|
13.5 mmHg
Standard Deviation 24.05
|
19.2 mmHg
Standard Deviation 32.20
|
10.1 mmHg
Standard Deviation 14.00
|
13.8 mmHg
Standard Deviation 10.39
|
29.8 mmHg
Standard Deviation 31.53
|
1.1 mmHg
Standard Deviation 2.35
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, and 60 minutes post-dosePopulation: This analysis is a comparison of TSC cohort compared to Placebo; therefore, the total number analyzed is less, as there are not specific data reported for the Placebo cohort. One subject from the TSC 2.5 mg/kg cohort was excluded due to subcutaneous injection of TSC.
Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2.
Outcome measures
| Measure |
TSC 0.5 mg/kg
n=5 Participants
TSC 0.5 mg/kg given as a one-time IV bolus injection
Trans-Sodium Crocetinate: TSC given as a one-time IV bolus injection
|
TSC 1.0 mg/kg
n=5 Participants
TSC 1.0 mg/kg given as a one-time IV bolus injection
Trans-Sodium Crocetinate: TSC given as a one-time IV bolus injection
|
TSC 1.5 mg/kg
n=5 Participants
TSC 1.5 mg/kg given as a one-time IV bolus injection
Trans-Sodium Crocetinate: TSC given as a one-time IV bolus injection
|
TSC 2.0 mg/kg
n=5 Participants
TSC 2.0 mg/kg given as a one-time IV bolus injection
Trans-Sodium Crocetinate: TSC given as a one-time IV bolus injection
|
TSC 2.5 mg/kg
n=4 Participants
TSC 2.5 mg/kg given as a one-time IV bolus injection
Trans-Sodium Crocetinate: TSC given as a one-time IV bolus injection
|
Placebo
Placebo given as a one-time IV bolus injection
|
|---|---|---|---|---|---|---|
|
Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo.
0-5 Minutes Post-Dose
|
-4.1 mmHg
Interval -37.0 to 28.7
|
-7.6 mmHg
Interval -41.1 to 25.9
|
-3.3 mmHg
Interval -36.1 to 29.5
|
10.5 mmHg
Interval -22.4 to 43.3
|
21.1 mmHg
Interval -13.7 to 55.9
|
—
|
|
Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo.
5-10 Minutes Post-Dose
|
5.6 mmHg
Interval -27.2 to 38.4
|
2.7 mmHg
Interval -30.8 to 36.2
|
0.5 mmHg
Interval -32.3 to 33.4
|
19.2 mmHg
Interval -13.6 to 52.0
|
37.0 mmHg
Interval 2.2 to 71.9
|
—
|
|
Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo.
10-15 Minutes Post-Dose
|
20.2 mmHg
Interval -12.6 to 53.0
|
8.2 mmHg
Interval -25.3 to 41.7
|
11.4 mmHg
Interval -21.5 to 44.2
|
11.2 mmHg
Interval -21.7 to 44.0
|
37.2 mmHg
Interval 2.3 to 72.0
|
—
|
|
Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo.
15-20 Minutes Post-Dose
|
18.6 mmHg
Interval -14.3 to 51.4
|
19.0 mmHg
Interval -14.5 to 52.5
|
13.4 mmHg
Interval -19.4 to 46.2
|
16.4 mmHg
Interval -16.4 to 49.2
|
29.8 mmHg
Interval -5.1 to 64.6
|
—
|
|
Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo.
20-25 Minutes Post-Dose
|
11.1 mmHg
Interval -21.7 to 44.0
|
22.9 mmHg
Interval -10.6 to 56.4
|
14.8 mmHg
Interval -18.0 to 47.6
|
16.2 mmHg
Interval -16.7 to 49.0
|
34.9 mmHg
Interval 0.0 to 69.7
|
—
|
|
Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo.
25-30 Minutes Post-Dose
|
13.6 mmHg
Interval -19.3 to 46.4
|
24.3 mmHg
Interval -9.2 to 57.8
|
10.2 mmHg
Interval -22.6 to 43.0
|
7.1 mmHg
Interval -25.7 to 40.0
|
26.1 mmHg
Interval -8.8 to 60.9
|
—
|
|
Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo.
30-35 Minutes Post-Dose
|
9.6 mmHg
Interval -23.3 to 42.4
|
13.6 mmHg
Interval -19.9 to 47.1
|
8.2 mmHg
Interval -24.7 to 41.0
|
0.1 mmHg
Interval -32.8 to 32.9
|
20.9 mmHg
Interval -13.9 to 55.7
|
—
|
|
Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo.
35-40 Minutes Post-Dose
|
11.6 mmHg
Interval -21.3 to 44.4
|
33.3 mmHg
Interval 0.5 to 66.1
|
14.4 mmHg
Interval -18.4 to 47.2
|
3.1 mmHg
Interval -29.7 to 35.9
|
26.0 mmHg
Interval -8.8 to 60.9
|
—
|
|
Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo.
40-45 Minutes Post-Dose
|
14.7 mmHg
Interval -18.1 to 47.5
|
43.5 mmHg
Interval 10.7 to 76.3
|
14.9 mmHg
Interval -17.9 to 47.7
|
6.9 mmHg
Interval -25.9 to 39.7
|
23.6 mmHg
Interval -11.3 to 58.4
|
—
|
|
Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo.
45-50 Minutes Post-Dose
|
15.8 mmHg
Interval -17.1 to 48.6
|
26.4 mmHg
Interval -6.4 to 59.2
|
17.4 mmHg
Interval -15.4 to 50.2
|
4.8 mmHg
Interval -28.0 to 37.7
|
24.1 mmHg
Interval -10.8 to 58.9
|
—
|
|
Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo.
50-55 Minutes Post-Dose
|
3.7 mmHg
Interval -29.1 to 36.5
|
4.4 mmHg
Interval -28.4 to 37.2
|
6.2 mmHg
Interval -26.6 to 39.0
|
-3.3 mmHg
Interval -36.2 to 29.5
|
16.1 mmHg
Interval -18.7 to 50.9
|
—
|
|
Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo.
55-60 Minutes Post-Dose
|
12.4 mmHg
Interval -20.4 to 45.3
|
18.1 mmHg
Interval -14.7 to 51.0
|
9.0 mmHg
Interval -23.8 to 41.8
|
12.7 mmHg
Interval -20.1 to 45.5
|
28.7 mmHg
Interval -6.1 to 63.5
|
—
|
Adverse Events
TSC 0.5 mg/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TSC 1.0 mg/kg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
TSC 1.5 mg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
TSC 2.0 mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
TSC 2.5 mg/kg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TSC 0.5 mg/kg
n=5 participants at risk
TSC 0.5 mg/kg given as a one-time IV bolus injection
Trans-Sodium Crocetinate: TSC given as a one-time IV bolus injection
|
TSC 1.0 mg/kg
n=5 participants at risk
TSC 1.0 mg/kg given as a one-time IV bolus injection
Trans-Sodium Crocetinate: TSC given as a one-time IV bolus injection
|
TSC 1.5 mg/kg
n=5 participants at risk
TSC 1.5 mg/kg given as a one-time IV bolus injection
Trans-Sodium Crocetinate: TSC given as a one-time IV bolus injection
|
TSC 2.0 mg/kg
n=5 participants at risk
TSC 2.0 mg/kg given as a one-time IV bolus injection
Trans-Sodium Crocetinate: TSC given as a one-time IV bolus injection
|
TSC 2.5 mg/kg
n=5 participants at risk
TSC 2.5 mg/kg given as a one-time IV bolus injection
Trans-Sodium Crocetinate: TSC given as a one-time IV bolus injection
|
Placebo
n=5 participants at risk
7 mL normal saline given as a one-time IV bolus injection
Placebo: Placebo normal saline given as a one-time 7 mL one-time IV bolus injection
|
|---|---|---|---|---|---|---|
|
General disorders
Injection Site Pain
|
0.00%
0/5 • AEs were collected up to 5 days from the start of equilibration (Day 0) through the 48-hour follow-up visit (Day 3 +2d).
|
0.00%
0/5 • AEs were collected up to 5 days from the start of equilibration (Day 0) through the 48-hour follow-up visit (Day 3 +2d).
|
0.00%
0/5 • AEs were collected up to 5 days from the start of equilibration (Day 0) through the 48-hour follow-up visit (Day 3 +2d).
|
0.00%
0/5 • AEs were collected up to 5 days from the start of equilibration (Day 0) through the 48-hour follow-up visit (Day 3 +2d).
|
20.0%
1/5 • Number of events 1 • AEs were collected up to 5 days from the start of equilibration (Day 0) through the 48-hour follow-up visit (Day 3 +2d).
|
0.00%
0/5 • AEs were collected up to 5 days from the start of equilibration (Day 0) through the 48-hour follow-up visit (Day 3 +2d).
|
|
General disorders
Injection Site Streaking
|
0.00%
0/5 • AEs were collected up to 5 days from the start of equilibration (Day 0) through the 48-hour follow-up visit (Day 3 +2d).
|
0.00%
0/5 • AEs were collected up to 5 days from the start of equilibration (Day 0) through the 48-hour follow-up visit (Day 3 +2d).
|
0.00%
0/5 • AEs were collected up to 5 days from the start of equilibration (Day 0) through the 48-hour follow-up visit (Day 3 +2d).
|
0.00%
0/5 • AEs were collected up to 5 days from the start of equilibration (Day 0) through the 48-hour follow-up visit (Day 3 +2d).
|
20.0%
1/5 • Number of events 1 • AEs were collected up to 5 days from the start of equilibration (Day 0) through the 48-hour follow-up visit (Day 3 +2d).
|
0.00%
0/5 • AEs were collected up to 5 days from the start of equilibration (Day 0) through the 48-hour follow-up visit (Day 3 +2d).
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • AEs were collected up to 5 days from the start of equilibration (Day 0) through the 48-hour follow-up visit (Day 3 +2d).
|
20.0%
1/5 • Number of events 1 • AEs were collected up to 5 days from the start of equilibration (Day 0) through the 48-hour follow-up visit (Day 3 +2d).
|
0.00%
0/5 • AEs were collected up to 5 days from the start of equilibration (Day 0) through the 48-hour follow-up visit (Day 3 +2d).
|
0.00%
0/5 • AEs were collected up to 5 days from the start of equilibration (Day 0) through the 48-hour follow-up visit (Day 3 +2d).
|
0.00%
0/5 • AEs were collected up to 5 days from the start of equilibration (Day 0) through the 48-hour follow-up visit (Day 3 +2d).
|
0.00%
0/5 • AEs were collected up to 5 days from the start of equilibration (Day 0) through the 48-hour follow-up visit (Day 3 +2d).
|
|
Nervous system disorders
Taste Disorder
|
0.00%
0/5 • AEs were collected up to 5 days from the start of equilibration (Day 0) through the 48-hour follow-up visit (Day 3 +2d).
|
0.00%
0/5 • AEs were collected up to 5 days from the start of equilibration (Day 0) through the 48-hour follow-up visit (Day 3 +2d).
|
0.00%
0/5 • AEs were collected up to 5 days from the start of equilibration (Day 0) through the 48-hour follow-up visit (Day 3 +2d).
|
20.0%
1/5 • Number of events 1 • AEs were collected up to 5 days from the start of equilibration (Day 0) through the 48-hour follow-up visit (Day 3 +2d).
|
0.00%
0/5 • AEs were collected up to 5 days from the start of equilibration (Day 0) through the 48-hour follow-up visit (Day 3 +2d).
|
0.00%
0/5 • AEs were collected up to 5 days from the start of equilibration (Day 0) through the 48-hour follow-up visit (Day 3 +2d).
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/5 • AEs were collected up to 5 days from the start of equilibration (Day 0) through the 48-hour follow-up visit (Day 3 +2d).
|
0.00%
0/5 • AEs were collected up to 5 days from the start of equilibration (Day 0) through the 48-hour follow-up visit (Day 3 +2d).
|
20.0%
1/5 • Number of events 1 • AEs were collected up to 5 days from the start of equilibration (Day 0) through the 48-hour follow-up visit (Day 3 +2d).
|
20.0%
1/5 • Number of events 1 • AEs were collected up to 5 days from the start of equilibration (Day 0) through the 48-hour follow-up visit (Day 3 +2d).
|
0.00%
0/5 • AEs were collected up to 5 days from the start of equilibration (Day 0) through the 48-hour follow-up visit (Day 3 +2d).
|
0.00%
0/5 • AEs were collected up to 5 days from the start of equilibration (Day 0) through the 48-hour follow-up visit (Day 3 +2d).
|
|
Injury, poisoning and procedural complications
Post-Procedural Erythema
|
0.00%
0/5 • AEs were collected up to 5 days from the start of equilibration (Day 0) through the 48-hour follow-up visit (Day 3 +2d).
|
0.00%
0/5 • AEs were collected up to 5 days from the start of equilibration (Day 0) through the 48-hour follow-up visit (Day 3 +2d).
|
20.0%
1/5 • Number of events 1 • AEs were collected up to 5 days from the start of equilibration (Day 0) through the 48-hour follow-up visit (Day 3 +2d).
|
20.0%
1/5 • Number of events 1 • AEs were collected up to 5 days from the start of equilibration (Day 0) through the 48-hour follow-up visit (Day 3 +2d).
|
0.00%
0/5 • AEs were collected up to 5 days from the start of equilibration (Day 0) through the 48-hour follow-up visit (Day 3 +2d).
|
0.00%
0/5 • AEs were collected up to 5 days from the start of equilibration (Day 0) through the 48-hour follow-up visit (Day 3 +2d).
|
|
Injury, poisoning and procedural complications
Post-Procedural Pruritus
|
0.00%
0/5 • AEs were collected up to 5 days from the start of equilibration (Day 0) through the 48-hour follow-up visit (Day 3 +2d).
|
0.00%
0/5 • AEs were collected up to 5 days from the start of equilibration (Day 0) through the 48-hour follow-up visit (Day 3 +2d).
|
20.0%
1/5 • Number of events 1 • AEs were collected up to 5 days from the start of equilibration (Day 0) through the 48-hour follow-up visit (Day 3 +2d).
|
0.00%
0/5 • AEs were collected up to 5 days from the start of equilibration (Day 0) through the 48-hour follow-up visit (Day 3 +2d).
|
0.00%
0/5 • AEs were collected up to 5 days from the start of equilibration (Day 0) through the 48-hour follow-up visit (Day 3 +2d).
|
0.00%
0/5 • AEs were collected up to 5 days from the start of equilibration (Day 0) through the 48-hour follow-up visit (Day 3 +2d).
|
Additional Information
Chris Galloway, MD (Chief Medical Officer)
Diffusion Pharmaceuticals
Phone: (434) 220-0718
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place