Healthy Subjects
Conditions
Keywords
Transcutaneous oximetry
Brief summary
Randomized, double-blind, placebo-controlled, pharmacokinetic, pharmacodynamic study. Subjects will be randomized to TSC or placebo to determine the effect of Trans Sodium Crocetinate (TSC) on Transcutaneous Oximetry Measurements (tcpO2) following a single administration of TSC in subjects breathing oxygen (O2).
Detailed description
This is a randomized, double-blind, placebo-controlled, pharmacokinetic, pharmacodynamic study of Trans Sodium Crocetinate (TSC) in healthy volunteers. The primary objective is to determine the effect of TSC on transcutaneous oximetry measurements (tcpO2) following a single administration of TSC in subjects breathing oxygen (O2). 30 healthy volunteers will be randomized to one of 6 treatment groups, to include 5 TSC doses (0.5, 1.0, 1.5, 2.0, and 2.5 mg/kg) and placebo normal saline (7 mL). TcpO2 sensors will be applied to 4 standardized areas on the lower extremity. Subjects will be placed on O2 via simple face mask at 6 L/minute, and will remain on O2 for 70 minutes prior to study drug administration. The first 10 minutes will allow for equilibration of O2 levels, and the subsequent 60 minutes will serve as the baseline period. TcpO2 values and SpO2 will be recorded every 5 minutes during the above periods. At the end of the 70-minute equilibration/baseline period, subjects will receive a single IV bolus injection of TSC at a dose of 0.5, 1.0, 1.5, 2.0 or 2.5 mg/kg, or placebo. Study drug will be administered in a blinded fashion. After study drug is administered, subjects will continue on O2 and be evaluated for an additional 60 minutes, with tcpO2 and SpO2 recorded at 1, 2, and 5 minutes post-dose, and every 5 minutes thereafter. Prior to and following study drug administration, PK samples will be obtained pre-dose, and 1, 10, 30, and 90 minutes post-dose. After the 60 minute post-treatment evaluation period, oxygen will be discontinued and the tcpO2 sensor electrodes removed. Subjects will remain in the procedure room for an additional 30 minutes to allow for collection of the 1.5-hour PK blood draw and repeat vital signs. Subjects will remain in the clinic overnight for observation and discharged the following morning. Subjects will be contacted by telephone at 48 hours (+ 2 days) for a safety follow up to assess adverse events and new medications.
Interventions
TSC given as a one-time IV bolus injection
DRUGPlacebo
Placebo normal saline given as a one-time 7 mL one-time IV bolus injection
Sponsors
Diffusion Pharmaceuticals Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male or female, age 18-50 2. Able and willing to lie quietly supine or semi-recumbent for up to 2.5 hours 3. Abstinence from exercise, caffeine, alcohol, nicotine, and a heavy meal prior to testing on the day of the Treatment Visit 4. Subject is able to communicate effectively with the Investigator and to comply with all study requirements, restrictions, and directions from the study staff 5. Females of childbearing potential must have a negative blood pregnancy test at screening and agree to use one of the accepted contraceptive regimens, or a double method of birth control (e.g. condom and spermicide), during the study and at least 30 days after the last dose of study drug. Females of non-childbearing potential should be surgically sterile or at least one year post-menopausal. 6. Males who engage in sexual activity that has the risk of pregnancy must agree to use a double barrier method (e.g. condom and spermicide) and agree not to donate sperm during the study and for at least 90 days after the last dose of study drug
Exclusion criteria
1. Allergy to study medication 2. Pregnant or breastfeeding 3. Current smoker and/or any nicotine use within 4 hours of the start of tcpO2 procedures, to include e-cigarette vaping, snuff, chew, nicotine gum and nicotine patches 4. Body Mass Index (BMI) \> 30 5. Positive test results for HIV-1/HIV-2 Antibodies, Hepatitis B surface Antigen (HBsAg), or Hepatitis C Antibody (HCVAb) 6. Blood donation (excluding plasma donation) of approximately 500 mL within 56 days prior to screening 7. Plasma donation within 7 days prior to screening 8. Treatment with an investigational drug within 30 days or 5 times the half-life (whichever is longer) prior to screening 9. Any skin condition on limbs to be tested that could impair testing (rash, wound, prior radiation therapy, other skin conditions, per Principal Investigator (PI) discretion) 10. Known cardiovascular disease, including treated or untreated hypertension 11. Significant respiratory disease and/or any other significant medical condition 12. Subject has an acute illness (gastrointestinal infection, influenza, or known inflammatory process) at the Treatment Visit 13. Urine screen positive for drugs or positive breathalyzer for alcohol (at screening and enrollment) 14. Concomitant medications used to treat a diagnosed medical condition 15. Subject who, for any reason, is deemed by the Investigator to be unsuitable for the study; or has any condition that would interfere with the evaluation of tissue oxygen measurements or PK of the investigational drug; or is otherwise unable to comply with the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, and 60 minutes post-dose | Summary Statistics of tcpO2 Levels (mmHg) Overall Measurements (Median of 4 Sensors) in Healthy Subjects |
Other
| Measure | Time frame | Description |
|---|---|---|
| Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, and 60 minutes post-dose | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 5 |
| 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 | 5 |
| 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 | 5 |
| 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 | 5 |
| 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 | 5 |
| 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 | 5 |
| Total | 30 |
Baseline characteristics
| Characteristic | TSC 0.5 mg/kg | TSC 1.5 mg/kg | TSC 2.0 mg/kg | TSC 2.5 mg/kg | Placebo | TSC 1.0 mg/kg | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 5 Participants | 5 Participants | 5 Participants | 5 Participants | 5 Participants | 30 Participants |
| Age, Continuous | 31.0 years STANDARD_DEVIATION 10.93 | 33.0 years STANDARD_DEVIATION 9.17 | 29.8 years STANDARD_DEVIATION 5.12 | 40.4 years STANDARD_DEVIATION 8.41 | 27.0 years STANDARD_DEVIATION 5 | 37.4 years STANDARD_DEVIATION 11.44 | 33.1 years STANDARD_DEVIATION 9.19 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 4 Participants | 4 Participants | 5 Participants | 5 Participants | 5 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 3 Participants | 3 Participants | 4 Participants | 4 Participants | 19 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 2 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 9 Participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 2 Participants | 3 Participants | 1 Participants | 3 Participants | 14 Participants |
| Sex: Female, Male Male | 3 Participants | 2 Participants | 3 Participants | 2 Participants | 4 Participants | 2 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 0 / 5 | 1 / 5 | 2 / 5 | 3 / 5 | 1 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 |
Outcome results
Primary
Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2.
Summary Statistics of tcpO2 Levels (mmHg) Overall Measurements (Median of 4 Sensors) in Healthy Subjects
Time frame: 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, and 60 minutes post-dose
Population: One subject from the TSC 2.5 mg/kg cohort was excluded due to subcutaneous injection of TSC.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TSC 0.5 mg/kg | 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 |
| TSC 0.5 mg/kg | 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 |
| TSC 0.5 mg/kg | 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 |
| TSC 0.5 mg/kg | 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 |
| TSC 0.5 mg/kg | 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 |
| TSC 0.5 mg/kg | 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 |
| TSC 0.5 mg/kg | 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 |
| TSC 0.5 mg/kg | 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 |
| TSC 0.5 mg/kg | 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 74.5 |
| TSC 0.5 mg/kg | 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 |
| TSC 0.5 mg/kg | 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 |
| TSC 0.5 mg/kg | 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 |
| TSC 0.5 mg/kg | 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 |
| TSC 0.5 mg/kg | 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 |
| TSC 0.5 mg/kg | 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 |
| TSC 0.5 mg/kg | 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 81.8 |
| TSC 0.5 mg/kg | 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 |
| TSC 0.5 mg/kg | 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 |
| TSC 0.5 mg/kg | 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 |
| TSC 0.5 mg/kg | 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 |
| TSC 0.5 mg/kg | 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 |
| TSC 0.5 mg/kg | 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 |
| TSC 0.5 mg/kg | 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 |
| TSC 0.5 mg/kg | 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 68.8 |
| TSC 0.5 mg/kg | 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 |
| TSC 0.5 mg/kg | 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 |
| TSC 0.5 mg/kg | 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 70.8 |
| TSC 0.5 mg/kg | 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 |
| TSC 0.5 mg/kg | 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 |
| TSC 0.5 mg/kg | 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 |
| TSC 0.5 mg/kg | 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 |
| TSC 0.5 mg/kg | 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 |
| TSC 0.5 mg/kg | 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 |
| TSC 0.5 mg/kg | 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 |
| TSC 0.5 mg/kg | 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 |
| TSC 0.5 mg/kg | 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 |
| TSC 1.0 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 35 to 40 Minutes (Period 2) | 180.9 mmHg | Standard Deviation 66.13 |
| TSC 1.0 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 5 to 10 Minutes (Period 2) | 159.4 mmHg | Standard Deviation 41.05 |
| TSC 1.0 mg/kg | 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) | 34.5 mmHg | Standard Deviation 47.14 |
| TSC 1.0 mg/kg | 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) | 27.2 mmHg | Standard Deviation 56.55 |
| TSC 1.0 mg/kg | 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) | 141.3 mmHg | Standard Deviation 35.52 |
| TSC 1.0 mg/kg | 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) | 148.9 mmHg | Standard Deviation 34.66 |
| TSC 1.0 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 40 to 45 Minutes (Period 2) | 180.6 mmHg | Standard Deviation 66.93 |
| TSC 1.0 mg/kg | 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) | 43.5 mmHg | Standard Deviation 70 |
| TSC 1.0 mg/kg | 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) | 4.3 mmHg | Standard Deviation 5.1 |
| TSC 1.0 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 0 to 5 Minutes (Period 2) | 165.8 mmHg | Standard Deviation 41.36 |
| TSC 1.0 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 25 to 30 Minutes (Period 2) | 182.0 mmHg | Standard Deviation 64.23 |
| TSC 1.0 mg/kg | 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) | 160.3 mmHg | Standard Deviation 36.89 |
| TSC 1.0 mg/kg | 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) | 20.7 mmHg | Standard Deviation 38.43 |
| TSC 1.0 mg/kg | 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) | 7.9 mmHg | Standard Deviation 12.62 |
| TSC 1.0 mg/kg | 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) | 164.8 mmHg | Standard Deviation 29.95 |
| TSC 1.0 mg/kg | 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) | 162.3 mmHg | Standard Deviation 36.34 |
| TSC 1.0 mg/kg | 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) | 16.8 mmHg | Standard Deviation 22.89 |
| TSC 1.0 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 15 to 20 Minutes (Period 2) | 174.8 mmHg | Standard Deviation 51.85 |
| TSC 1.0 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 10 to 15 Minutes (Period 2) | 167.5 mmHg | Standard Deviation 47.82 |
| TSC 1.0 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 20 to 25 Minutes (Period 2) | 180.6 mmHg | Standard Deviation 57.06 |
| TSC 1.0 mg/kg | 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) | 5.6 mmHg | Standard Deviation 10.79 |
| TSC 1.0 mg/kg | 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) | 19.2 mmHg | Standard Deviation 32.2 |
| TSC 1.0 mg/kg | 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) | 166.4 mmHg | Standard Deviation 31.95 |
| TSC 1.0 mg/kg | 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) | 159.4 mmHg | Standard Deviation 40.33 |
| TSC 1.0 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 55 to 60 Minutes (Period 2) | 175.5 mmHg | Standard Deviation 69.98 |
| TSC 1.0 mg/kg | 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) | 22.1 mmHg | Standard Deviation 44.13 |
| TSC 1.0 mg/kg | 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) | 160.8 mmHg | Standard Deviation 45.32 |
| TSC 1.0 mg/kg | 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) | 148.1 mmHg | Standard Deviation 38.63 |
| TSC 1.0 mg/kg | 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) | 153.1 mmHg | Standard Deviation 41.18 |
| TSC 1.0 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 30 to 35 Minutes (Period 2) | 172.4 mmHg | Standard Deviation 51.69 |
| TSC 1.0 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 45 to 50 Minutes (Period 2) | 173.4 mmHg | Standard Deviation 58.98 |
| TSC 1.0 mg/kg | 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) | 11.0 mmHg | Standard Deviation 14.14 |
| TSC 1.0 mg/kg | 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) | 17.3 mmHg | Standard Deviation 26.5 |
| TSC 1.0 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 50 to 55 Minutes (Period 2) | 174.4 mmHg | Standard Deviation 60.55 |
| TSC 1.0 mg/kg | 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) | 151.5 mmHg | Standard Deviation 37.51 |
| TSC 1.0 mg/kg | 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) | 168.9 mmHg | Standard Deviation 49.2 |
| TSC 1.5 mg/kg | 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) | 178.0 mmHg | Standard Deviation 62.28 |
| TSC 1.5 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 25 to 30 Minutes (Period 2) | 182.0 mmHg | Standard Deviation 44.54 |
| TSC 1.5 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 40 to 45 Minutes (Period 2) | 174.3 mmHg | Standard Deviation 35.85 |
| TSC 1.5 mg/kg | 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) | 181.7 mmHg | Standard Deviation 56.1 |
| TSC 1.5 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 0 to 5 Minutes (Period 2) | 180.0 mmHg | Standard Deviation 46.72 |
| TSC 1.5 mg/kg | 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) | 176.2 mmHg | Standard Deviation 56.77 |
| TSC 1.5 mg/kg | 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) | 14.0 mmHg | Standard Deviation 20.96 |
| TSC 1.5 mg/kg | 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) | 10.2 mmHg | Standard Deviation 14.06 |
| TSC 1.5 mg/kg | 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) | 179.8 mmHg | Standard Deviation 60.77 |
| TSC 1.5 mg/kg | 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) | 177.2 mmHg | Standard Deviation 47.41 |
| TSC 1.5 mg/kg | 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) | 178.6 mmHg | Standard Deviation 58.66 |
| TSC 1.5 mg/kg | 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) | 14.8 mmHg | Standard Deviation 14.47 |
| TSC 1.5 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 35 to 40 Minutes (Period 2) | 177.4 mmHg | Standard Deviation 38.83 |
| TSC 1.5 mg/kg | 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) | 175.8 mmHg | Standard Deviation 64.14 |
| TSC 1.5 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 5 to 10 Minutes (Period 2) | 184.1 mmHg | Standard Deviation 57.54 |
| TSC 1.5 mg/kg | 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) | 4.4 mmHg | Standard Deviation 4.88 |
| TSC 1.5 mg/kg | 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) | 12.8 mmHg | Standard Deviation 12.81 |
| TSC 1.5 mg/kg | 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) | 14.9 mmHg | Standard Deviation 16.14 |
| TSC 1.5 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 15 to 20 Minutes (Period 2) | 184.5 mmHg | Standard Deviation 43.3 |
| TSC 1.5 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 10 to 15 Minutes (Period 2) | 183.9 mmHg | Standard Deviation 48.67 |
| TSC 1.5 mg/kg | 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) | 18.2 mmHg | Standard Deviation 17.92 |
| TSC 1.5 mg/kg | 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) | 13.4 mmHg | Standard Deviation 14.46 |
| TSC 1.5 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 30 to 35 Minutes (Period 2) | 176.8 mmHg | Standard Deviation 41.05 |
| TSC 1.5 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 20 to 25 Minutes (Period 2) | 180.2 mmHg | Standard Deviation 46.04 |
| TSC 1.5 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 45 to 50 Minutes (Period 2) | 170.1 mmHg | Standard Deviation 39.37 |
| TSC 1.5 mg/kg | 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) | 180.7 mmHg | Standard Deviation 64.26 |
| TSC 1.5 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 50 to 55 Minutes (Period 2) | 178.2 mmHg | Standard Deviation 40.18 |
| TSC 1.5 mg/kg | 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) | 175.5 mmHg | Standard Deviation 61.35 |
| TSC 1.5 mg/kg | 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) | 10.1 mmHg | Standard Deviation 14 |
| TSC 1.5 mg/kg | 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) | 15.6 mmHg | Standard Deviation 15.71 |
| TSC 1.5 mg/kg | 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) | 13.3 mmHg | Standard Deviation 12.05 |
| TSC 1.5 mg/kg | 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) | 177.1 mmHg | Standard Deviation 61.65 |
| TSC 1.5 mg/kg | 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) | 178.8 mmHg | Standard Deviation 59.96 |
| TSC 1.5 mg/kg | 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) | 12.1 mmHg | Standard Deviation 16.57 |
| TSC 1.5 mg/kg | 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) | 173.2 mmHg | Standard Deviation 55.79 |
| TSC 1.5 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 55 to 60 Minutes (Period 2) | 172.1 mmHg | Standard Deviation 42.22 |
| TSC 2.0 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 15 to 20 Minutes (Period 2) | 206.4 mmHg | Standard Deviation 20.96 |
| TSC 2.0 mg/kg | 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) | 179.9 mmHg | Standard Deviation 44.78 |
| TSC 2.0 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 0 to 5 Minutes (Period 2) | 203.3 mmHg | Standard Deviation 51.59 |
| TSC 2.0 mg/kg | 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) | 187.4 mmHg | Standard Deviation 46.58 |
| TSC 2.0 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 5 to 10 Minutes (Period 2) | 206.9 mmHg | Standard Deviation 52.15 |
| TSC 2.0 mg/kg | 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) | 23.1 mmHg | Standard Deviation 22.02 |
| TSC 2.0 mg/kg | 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) | 196.6 mmHg | Standard Deviation 48.62 |
| TSC 2.0 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 10 to 15 Minutes (Period 2) | 201.8 mmHg | Standard Deviation 22.56 |
| TSC 2.0 mg/kg | 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) | 13.1 mmHg | Standard Deviation 18.02 |
| TSC 2.0 mg/kg | 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) | 200.9 mmHg | Standard Deviation 51.63 |
| TSC 2.0 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 20 to 25 Minutes (Period 2) | 214.4 mmHg | Standard Deviation 41.19 |
| TSC 2.0 mg/kg | 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) | 16.2 mmHg | Standard Deviation 15.83 |
| TSC 2.0 mg/kg | 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) | 200.8 mmHg | Standard Deviation 44.5 |
| TSC 2.0 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 25 to 30 Minutes (Period 2) | 202.7 mmHg | Standard Deviation 36.8 |
| TSC 2.0 mg/kg | 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) | 7.2 mmHg | Standard Deviation 7.91 |
| TSC 2.0 mg/kg | 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) | 212.1 mmHg | Standard Deviation 46.47 |
| TSC 2.0 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 30 to 35 Minutes (Period 2) | 200.5 mmHg | Standard Deviation 37.18 |
| TSC 2.0 mg/kg | 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) | 5.9 mmHg | Standard Deviation 11.59 |
| TSC 2.0 mg/kg | 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) | 217.9 mmHg | Standard Deviation 55.35 |
| TSC 2.0 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 35 to 40 Minutes (Period 2) | 200.3 mmHg | Standard Deviation 40.66 |
| TSC 2.0 mg/kg | 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) | 4.3 mmHg | Standard Deviation 9.5 |
| TSC 2.0 mg/kg | 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) | 208.2 mmHg | Standard Deviation 61.65 |
| TSC 2.0 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 40 to 45 Minutes (Period 2) | 209.2 mmHg | Standard Deviation 52.68 |
| TSC 2.0 mg/kg | 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) | 6.9 mmHg | Standard Deviation 9.61 |
| TSC 2.0 mg/kg | 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) | 5.7 mmHg | Standard Deviation 12.36 |
| TSC 2.0 mg/kg | 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) | 211.6 mmHg | Standard Deviation 49.69 |
| TSC 2.0 mg/kg | 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) | 3.3 mmHg | Standard Deviation 4.1 |
| TSC 2.0 mg/kg | 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) | 196.9 mmHg | Standard Deviation 43.77 |
| TSC 2.0 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 55 to 60 Minutes (Period 2) | 209.9 mmHg | Standard Deviation 50.43 |
| TSC 2.0 mg/kg | 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) | 13.8 mmHg | Standard Deviation 10.39 |
| TSC 2.0 mg/kg | 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) | 25.8 mmHg | Standard Deviation 20.66 |
| TSC 2.0 mg/kg | 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) | 16.4 mmHg | Standard Deviation 17.44 |
| TSC 2.0 mg/kg | 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) | 202.8 mmHg | Standard Deviation 46.65 |
| TSC 2.0 mg/kg | 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) | 208.7 mmHg | Standard Deviation 59.68 |
| TSC 2.0 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 45 to 50 Minutes (Period 2) | 211.1 mmHg | Standard Deviation 53.79 |
| TSC 2.0 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 50 to 55 Minutes (Period 2) | 208.1 mmHg | Standard Deviation 50.63 |
| TSC 2.5 mg/kg | 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) | 24.9 mmHg | Standard Deviation 31.39 |
| TSC 2.5 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 35 to 40 Minutes (Period 2) | 200.8 mmHg | Standard Deviation 122.86 |
| TSC 2.5 mg/kg | 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) | 177.8 mmHg | Standard Deviation 73.8 |
| TSC 2.5 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 5 to 10 Minutes (Period 2) | 194.0 mmHg | Standard Deviation 112.18 |
| TSC 2.5 mg/kg | 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) | 183.3 mmHg | Standard Deviation 97.5 |
| TSC 2.5 mg/kg | 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) | 26.8 mmHg | Standard Deviation 42.32 |
| TSC 2.5 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 50 to 55 Minutes (Period 2) | 203.6 mmHg | Standard Deviation 114.2 |
| TSC 2.5 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 30 to 35 Minutes (Period 2) | 198.0 mmHg | Standard Deviation 117.16 |
| TSC 2.5 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 45 to 50 Minutes (Period 2) | 204.6 mmHg | Standard Deviation 119.52 |
| TSC 2.5 mg/kg | 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) | 22.7 mmHg | Standard Deviation 18.62 |
| TSC 2.5 mg/kg | 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) | 175.4 mmHg | Standard Deviation 74.39 |
| TSC 2.5 mg/kg | 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) | 26.1 mmHg | Standard Deviation 42.86 |
| TSC 2.5 mg/kg | 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) | 182.5 mmHg | Standard Deviation 87.39 |
| TSC 2.5 mg/kg | 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) | 179.0 mmHg | Standard Deviation 84.54 |
| TSC 2.5 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 25 to 30 Minutes (Period 2) | 202.0 mmHg | Standard Deviation 116.66 |
| TSC 2.5 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 55 to 60 Minutes (Period 2) | 205.9 mmHg | Standard Deviation 119.43 |
| TSC 2.5 mg/kg | 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) | 180.1 mmHg | Standard Deviation 73.41 |
| TSC 2.5 mg/kg | 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) | 34.9 mmHg | Standard Deviation 49.62 |
| TSC 2.5 mg/kg | 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) | 29.8 mmHg | Standard Deviation 31.53 |
| TSC 2.5 mg/kg | 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) | 162.4 mmHg | Standard Deviation 60.01 |
| TSC 2.5 mg/kg | 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) | 160.1 mmHg | Standard Deviation 53.88 |
| TSC 2.5 mg/kg | 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) | 36.4 mmHg | Standard Deviation 45.84 |
| TSC 2.5 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 20 to 25 Minutes (Period 2) | 204.1 mmHg | Standard Deviation 113.93 |
| TSC 2.5 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 15 to 20 Minutes (Period 2) | 197.8 mmHg | Standard Deviation 110.08 |
| TSC 2.5 mg/kg | 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) | 172.8 mmHg | Standard Deviation 65.31 |
| TSC 2.5 mg/kg | 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) | 29.8 mmHg | Standard Deviation 45.52 |
| TSC 2.5 mg/kg | 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) | 39.1 mmHg | Standard Deviation 62.75 |
| TSC 2.5 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 0 to 5 Minutes (Period 2) | 194.7 mmHg | Standard Deviation 104.76 |
| TSC 2.5 mg/kg | 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) | 173.4 mmHg | Standard Deviation 64.31 |
| TSC 2.5 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 10 to 15 Minutes (Period 2) | 197.6 mmHg | Standard Deviation 113.49 |
| TSC 2.5 mg/kg | 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) | 162.6 mmHg | Standard Deviation 52.24 |
| TSC 2.5 mg/kg | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 40 to 45 Minutes (Period 2) | 199.8 mmHg | Standard Deviation 127.19 |
| TSC 2.5 mg/kg | 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) | 40.9 mmHg | Standard Deviation 57.17 |
| TSC 2.5 mg/kg | 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) | 23.6 mmHg | Standard Deviation 45.97 |
| TSC 2.5 mg/kg | 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) | 181.6 mmHg | Standard Deviation 81.21 |
| TSC 2.5 mg/kg | 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) | 27.2 mmHg | Standard Deviation 49.34 |
| Placebo | 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) | 197.2 mmHg | Standard Deviation 35.64 |
| Placebo | 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) | 209.1 mmHg | Standard Deviation 38.36 |
| Placebo | 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) | 217.0 mmHg | Standard Deviation 38.14 |
| Placebo | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 45 to 50 Minutes (Period 2) | 177.3 mmHg | Standard Deviation 63.38 |
| Placebo | 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) | 15.4 mmHg | Standard Deviation 10.74 |
| Placebo | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 20 to 25 Minutes (Period 2) | 196.3 mmHg | Standard Deviation 47.51 |
| Placebo | 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) | 200.5 mmHg | Standard Deviation 32.29 |
| Placebo | 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) | 5.9 mmHg | Standard Deviation 13.08 |
| Placebo | 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) | 3.9 mmHg | Standard Deviation 8.61 |
| Placebo | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 15 to 20 Minutes (Period 2) | 191.3 mmHg | Standard Deviation 35.59 |
| Placebo | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 50 to 55 Minutes (Period 2) | 181.2 mmHg | Standard Deviation 68.49 |
| Placebo | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 30 to 35 Minutes (Period 2) | 186.9 mmHg | Standard Deviation 51.28 |
| Placebo | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 40 to 45 Minutes (Period 2) | 179.0 mmHg | Standard Deviation 58.21 |
| Placebo | 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) | 207.9 mmHg | Standard Deviation 27.97 |
| Placebo | 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) | 211.9 mmHg | Standard Deviation 38.92 |
| Placebo | 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) | 1.2 mmHg | Standard Deviation 2.57 |
| Placebo | 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) | 6.6 mmHg | Standard Deviation 14.76 |
| Placebo | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 0 to 5 Minutes (Period 2) | 212.2 mmHg | Standard Deviation 42.48 |
| Placebo | 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) | 0.0 mmHg | Standard Deviation 0 |
| Placebo | 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) | 0.8 mmHg | Standard Deviation 1.79 |
| Placebo | 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) | 0.0 mmHg | Standard Deviation 0 |
| Placebo | 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) | 2.0 mmHg | Standard Deviation 4.36 |
| Placebo | 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) | 202.1 mmHg | Standard Deviation 35.29 |
| Placebo | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 25 to 30 Minutes (Period 2) | 184.8 mmHg | Standard Deviation 48.54 |
| Placebo | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 35 to 40 Minutes (Period 2) | 180.7 mmHg | Standard Deviation 56.25 |
| Placebo | 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) | 216.2 mmHg | Standard Deviation 34.75 |
| Placebo | 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) | 210.0 mmHg | Standard Deviation 38.8 |
| Placebo | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 10 to 15 Minutes (Period 2) | 189.5 mmHg | Standard Deviation 33.8 |
| Placebo | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 55 to 60 Minutes (Period 2) | 174.7 mmHg | Standard Deviation 65.35 |
| Placebo | 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) | 0.0 mmHg | Standard Deviation 0 |
| Placebo | 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) | 0.0 mmHg | Standard Deviation 0 |
| Placebo | 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) | 210.5 mmHg | Standard Deviation 38.04 |
| Placebo | 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) | 201.3 mmHg | Standard Deviation 34.41 |
| Placebo | 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) | 216.6 mmHg | Standard Deviation 37.24 |
| Placebo | 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) | 1.1 mmHg | Standard Deviation 2.35 |
| Placebo | Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2. | 5 to 10 Minutes (Period 2) | 191.4 mmHg | Standard Deviation 29.89 |
Other Pre-specified
Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo.
Determine the Dose-Response of TSC on tcpO2 Following a Single Administration of TSC in Subjects Breathing O2.
Time frame: 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, and 60 minutes post-dose
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TSC 0.5 mg/kg | 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 |
| TSC 0.5 mg/kg | 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 |
| TSC 0.5 mg/kg | 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 |
| TSC 0.5 mg/kg | 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 |
| TSC 0.5 mg/kg | 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 |
| TSC 0.5 mg/kg | 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 |
| TSC 0.5 mg/kg | 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 |
| TSC 0.5 mg/kg | 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 |
| TSC 0.5 mg/kg | 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 |
| TSC 0.5 mg/kg | 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 |
| TSC 0.5 mg/kg | 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 |
| TSC 0.5 mg/kg | 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 |
| TSC 1.0 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 40-45 Minutes Post-Dose | 43.5 mmHg |
| TSC 1.0 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 10-15 Minutes Post-Dose | 8.2 mmHg |
| TSC 1.0 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 50-55 Minutes Post-Dose | 4.4 mmHg |
| TSC 1.0 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 20-25 Minutes Post-Dose | 22.9 mmHg |
| TSC 1.0 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 0-5 Minutes Post-Dose | -7.6 mmHg |
| TSC 1.0 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 5-10 Minutes Post-Dose | 2.7 mmHg |
| TSC 1.0 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 45-50 Minutes Post-Dose | 26.4 mmHg |
| TSC 1.0 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 35-40 Minutes Post-Dose | 33.3 mmHg |
| TSC 1.0 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 30-35 Minutes Post-Dose | 13.6 mmHg |
| TSC 1.0 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 25-30 Minutes Post-Dose | 24.3 mmHg |
| TSC 1.0 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 15-20 Minutes Post-Dose | 19.0 mmHg |
| TSC 1.0 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 55-60 Minutes Post-Dose | 18.1 mmHg |
| TSC 1.5 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 0-5 Minutes Post-Dose | -3.3 mmHg |
| TSC 1.5 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 20-25 Minutes Post-Dose | 14.8 mmHg |
| TSC 1.5 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 30-35 Minutes Post-Dose | 8.2 mmHg |
| TSC 1.5 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 35-40 Minutes Post-Dose | 14.4 mmHg |
| TSC 1.5 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 40-45 Minutes Post-Dose | 14.9 mmHg |
| TSC 1.5 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 15-20 Minutes Post-Dose | 13.4 mmHg |
| TSC 1.5 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 50-55 Minutes Post-Dose | 6.2 mmHg |
| TSC 1.5 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 25-30 Minutes Post-Dose | 10.2 mmHg |
| TSC 1.5 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 55-60 Minutes Post-Dose | 9.0 mmHg |
| TSC 1.5 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 5-10 Minutes Post-Dose | 0.5 mmHg |
| TSC 1.5 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 45-50 Minutes Post-Dose | 17.4 mmHg |
| TSC 1.5 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 10-15 Minutes Post-Dose | 11.4 mmHg |
| TSC 2.0 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 15-20 Minutes Post-Dose | 16.4 mmHg |
| TSC 2.0 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 5-10 Minutes Post-Dose | 19.2 mmHg |
| TSC 2.0 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 20-25 Minutes Post-Dose | 16.2 mmHg |
| TSC 2.0 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 50-55 Minutes Post-Dose | -3.3 mmHg |
| TSC 2.0 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 35-40 Minutes Post-Dose | 3.1 mmHg |
| TSC 2.0 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 25-30 Minutes Post-Dose | 7.1 mmHg |
| TSC 2.0 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 40-45 Minutes Post-Dose | 6.9 mmHg |
| TSC 2.0 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 10-15 Minutes Post-Dose | 11.2 mmHg |
| TSC 2.0 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 0-5 Minutes Post-Dose | 10.5 mmHg |
| TSC 2.0 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 45-50 Minutes Post-Dose | 4.8 mmHg |
| TSC 2.0 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 55-60 Minutes Post-Dose | 12.7 mmHg |
| TSC 2.0 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 30-35 Minutes Post-Dose | 0.1 mmHg |
| TSC 2.5 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 10-15 Minutes Post-Dose | 37.2 mmHg |
| TSC 2.5 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 45-50 Minutes Post-Dose | 24.1 mmHg |
| TSC 2.5 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 0-5 Minutes Post-Dose | 21.1 mmHg |
| TSC 2.5 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 20-25 Minutes Post-Dose | 34.9 mmHg |
| TSC 2.5 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 35-40 Minutes Post-Dose | 26.0 mmHg |
| TSC 2.5 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 30-35 Minutes Post-Dose | 20.9 mmHg |
| TSC 2.5 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 5-10 Minutes Post-Dose | 37.0 mmHg |
| TSC 2.5 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 55-60 Minutes Post-Dose | 28.7 mmHg |
| TSC 2.5 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 25-30 Minutes Post-Dose | 26.1 mmHg |
| TSC 2.5 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 50-55 Minutes Post-Dose | 16.1 mmHg |
| TSC 2.5 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 15-20 Minutes Post-Dose | 29.8 mmHg |
| TSC 2.5 mg/kg | Summary of ANOVA Results (Difference [95% Confidence Interval]) for tcpO2 Time-Matched Values by TSC Cohort Compared to Placebo. | 40-45 Minutes Post-Dose | 23.6 mmHg |