Trial Outcomes & Findings for Safety and Efficacy of Trans Sodium Crocetinate (TSC) in SARS-CoV-2 (COVID-19) Infected Subjects (NCT NCT04573322)
NCT ID: NCT04573322
Last Updated: 2022-04-14
Results Overview
Lead-in phase: Overall summary of subjects with TEAEs
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Up to 70 days post-study drug administration
Results posted on
2022-04-14
Participant Flow
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
Participant milestones
| Measure |
Lead-in 0.25 mg/kg
0.25 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days
Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
|
Lead-in 0.50 mg/kg
0.50 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days
Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
|
Lead-in 1.0 mg/kg
1.0 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days
Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
|
Lead-in 1.5 mg/kg
1.5 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days
Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
7
|
6
|
|
Overall Study
COMPLETED
|
5
|
4
|
5
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of Trans Sodium Crocetinate (TSC) in SARS-CoV-2 (COVID-19) Infected Subjects
Baseline characteristics by cohort
| Measure |
Lead-in 0.25 mg/kg
n=6 Participants
0.25 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days
Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
|
Lead-in 0.50 mg/kg
n=6 Participants
0.50 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days
Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
|
Lead-in 1.0 mg/kg
n=7 Participants
1.0 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days
Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
|
Lead-in 1.5 mg/kg
n=6 Participants
1.5 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days
Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Age, Continuous
|
51.50 years
STANDARD_DEVIATION 18.87 • n=5 Participants
|
60.83 years
STANDARD_DEVIATION 16.04 • n=7 Participants
|
54.43 years
STANDARD_DEVIATION 8.16 • n=5 Participants
|
57.50 years
STANDARD_DEVIATION 8.89 • n=4 Participants
|
56.00 years
STANDARD_DEVIATION 13.16 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
Romania
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 70 days post-study drug administrationLead-in phase: Overall summary of subjects with TEAEs
Outcome measures
| Measure |
Lead-in 0.25 mg/kg
n=6 Participants
0.25 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days
Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
|
Lead-in 0.50 mg/kg
n=6 Participants
0.50 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days
Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
|
Lead-in 1.0 mg/kg
n=7 Participants
1.0 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days
Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
|
Lead-in 1.5 mg/kg
n=6 Participants
1.5 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days
Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
|
|---|---|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Patients with any TEAE
|
3 Participants
|
4 Participants
|
5 Participants
|
2 Participants
|
|
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Patients with any Serious TEAE
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Patients with any TEAE of DLT
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Patients with any TEAE Resulting in Death
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Patients with any TEAE Leading to Study Drug Discontinuation
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Patients with any TEAE Leading to Study Drug Interruption
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Patients with any TEAE with CTCAE Grade 3 or 4
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 28 daysLead-in phase: Time to achieve (and maintain through Day 28) a World Health Organization (WHO) ordinal COVID-19 severity scale score of 1, 2 or 3 with a minimum 1-point improvement from baseline. The scale assesses clinical status and the range is 0-8, as follows: 0\. Uninfected - No clinical or virological evidence of infection 1. Ambulatory - No limitation of activities 2. Ambulatory - Limitation of activities 3. Hospitalized, Mild Disease - Hospitalized, no oxygen therapy 4. Hospitalized, Mild Disease - Oxygen by mask or nasal prongs 5. Hospitalized Severe Disease - Non-invasive ventilation or high-low oxygen 6. Hospitalized Severe Disease - Intubation and mechanical ventilation 7. Hospitalized Severe Disease - Ventilation + additional organ support (pressors, Renal Replacement Therapy (RRT), Extracorporeal Membrane Oxygenation (ECMO) 8. Dead - Death
Outcome measures
| Measure |
Lead-in 0.25 mg/kg
n=6 Participants
0.25 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days
Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
|
Lead-in 0.50 mg/kg
n=6 Participants
0.50 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days
Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
|
Lead-in 1.0 mg/kg
n=7 Participants
1.0 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days
Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
|
Lead-in 1.5 mg/kg
n=6 Participants
1.5 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days
Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
|
|---|---|---|---|---|
|
Time to Recovery Through Day 28
|
14.33 days
Standard Deviation 11.54
|
13.67 days
Standard Deviation 8.43
|
7.71 days
Standard Deviation 4.31
|
7.50 days
Standard Deviation 1.22
|
SECONDARY outcome
Timeframe: 7 daysLead-in phase: Number and percentage of patients by WHO Severity Scale change from baseline through Day 7 World Health Organization (WHO) Ordinal Severity Scale 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities 3. Hospitalized, no requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, on non-invasive ventilation or high flow O2 6. Hospitalized, on invasive mechanical ventilation or ECMO 7. Death
Outcome measures
| Measure |
Lead-in 0.25 mg/kg
n=6 Participants
0.25 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days
Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
|
Lead-in 0.50 mg/kg
n=6 Participants
0.50 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days
Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
|
Lead-in 1.0 mg/kg
n=7 Participants
1.0 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days
Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
|
Lead-in 1.5 mg/kg
n=6 Participants
1.5 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days
Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
|
|---|---|---|---|---|
|
Change From Baseline in WHO Ordinal Severity Scale as a Categorical Improvement or Worsening
1 Point Worse from Day 1 to Day 7
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Change From Baseline in WHO Ordinal Severity Scale as a Categorical Improvement or Worsening
No Change from Day 1 to Day 7
|
3 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
|
Change From Baseline in WHO Ordinal Severity Scale as a Categorical Improvement or Worsening
1 Point Improvement from Day 1 to Day 7
|
1 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
|
Change From Baseline in WHO Ordinal Severity Scale as a Categorical Improvement or Worsening
No Data Collected on Day 7
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 28 daysLead-in phase: Ventilator free days in the first 28 days (to day 29).
Outcome measures
| Measure |
Lead-in 0.25 mg/kg
n=6 Participants
0.25 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days
Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
|
Lead-in 0.50 mg/kg
n=6 Participants
0.50 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days
Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
|
Lead-in 1.0 mg/kg
n=7 Participants
1.0 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days
Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
|
Lead-in 1.5 mg/kg
n=6 Participants
1.5 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days
Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
|
|---|---|---|---|---|
|
Oxygenation - Ventilator Free Days
|
19.7 days
Standard Deviation 6.05
|
16.00 days
Standard Deviation 5.33
|
15.43 days
Standard Deviation 7.28
|
19.83 days
Standard Deviation 1.17
|
SECONDARY outcome
Timeframe: 28 daysLead-in phase: Days of treatment during the inpatient period
Outcome measures
| Measure |
Lead-in 0.25 mg/kg
n=6 Participants
0.25 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days
Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
|
Lead-in 0.50 mg/kg
n=6 Participants
0.50 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days
Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
|
Lead-in 1.0 mg/kg
n=7 Participants
1.0 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days
Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
|
Lead-in 1.5 mg/kg
n=6 Participants
1.5 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days
Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
|
|---|---|---|---|---|
|
Hospital Length of Stay
|
8.67 days
Standard Deviation 2.66
|
9.67 days
Standard Deviation 2.88
|
8.57 days
Standard Deviation 3.78
|
8.00 days
Standard Deviation 2.19
|
SECONDARY outcome
Timeframe: 28 daysLead-in phase: Time to return to room air or baseline oxygen requirement
Outcome measures
| Measure |
Lead-in 0.25 mg/kg
n=6 Participants
0.25 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days
Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
|
Lead-in 0.50 mg/kg
n=6 Participants
0.50 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days
Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
|
Lead-in 1.0 mg/kg
n=7 Participants
1.0 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days
Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
|
Lead-in 1.5 mg/kg
n=6 Participants
1.5 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days
Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
|
|---|---|---|---|---|
|
Oxygenation - Time to Return to Baseline
|
7.50 days
Standard Deviation 5.68
|
18.92 days
Standard Deviation 18.25
|
11.79 days
Standard Deviation 7.47
|
5.50 days
Standard Deviation 2.45
|
SECONDARY outcome
Timeframe: Baseline through Day 10Population: There are some time points where data were not collected and, for the later timepoints, subjects discontinued.
Lead-in phase: Blood oxygenation by recorded continuous pulse oximetry (SpO2:FiO2 ratio)
Outcome measures
| Measure |
Lead-in 0.25 mg/kg
n=6 Participants
0.25 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days
Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
|
Lead-in 0.50 mg/kg
n=6 Participants
0.50 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days
Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
|
Lead-in 1.0 mg/kg
n=7 Participants
1.0 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days
Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
|
Lead-in 1.5 mg/kg
n=6 Participants
1.5 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days
Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
|
|---|---|---|---|---|
|
Oxygenation - Pulse Oximetry
Baseline (Pre First Dose)
|
261.83 SpO2:FiO2
Standard Deviation 73.80
|
164.33 SpO2:FiO2
Standard Deviation 64.91
|
183.97 SpO2:FiO2
Standard Deviation 41.34
|
255.03 SpO2:FiO2
Standard Deviation 57.54
|
|
Oxygenation - Pulse Oximetry
Day 1, Prior to Dose 1
|
261.83 SpO2:FiO2
Standard Deviation 73.80
|
164.33 SpO2:FiO2
Standard Deviation 64.91
|
183.97 SpO2:FiO2
Standard Deviation 41.34
|
255.03 SpO2:FiO2
Standard Deviation 57.54
|
|
Oxygenation - Pulse Oximetry
Day 1, 1 Minute Post Dose 1
|
261.22 SpO2:FiO2
Standard Deviation 74.87
|
163.33 SpO2:FiO2
Standard Deviation 61.87
|
189.16 SpO2:FiO2
Standard Deviation 46.07
|
255.33 SpO2:FiO2
Standard Deviation 57.03
|
|
Oxygenation - Pulse Oximetry
Day 1, 10 Minutes Post Dose 1
|
261.22 SpO2:FiO2
Standard Deviation 74.90
|
164.87 SpO2:FiO2
Standard Deviation 63.89
|
188.37 SpO2:FiO2
Standard Deviation 46.00
|
255.15 SpO2:FiO2
Standard Deviation 55.76
|
|
Oxygenation - Pulse Oximetry
Day 1, 30 Minutes Post Dose 1
|
260.73 SpO2:FiO2
Standard Deviation 76.50
|
165.67 SpO2:FiO2
Standard Deviation 63.91
|
187.81 SpO2:FiO2
Standard Deviation 45.89
|
256.07 SpO2:FiO2
Standard Deviation 56.38
|
|
Oxygenation - Pulse Oximetry
Day 1, 1.5 Hours Post Dose 1
|
263.22 SpO2:FiO2
Standard Deviation 76.78
|
164.32 SpO2:FiO2
Standard Deviation 62.38
|
187.89 SpO2:FiO2
Standard Deviation 45.01
|
255.65 SpO2:FiO2
Standard Deviation 54.28
|
|
Oxygenation - Pulse Oximetry
Day 1, 3 Hours Post Dose 1
|
262.82 SpO2:FiO2
Standard Deviation 78.20
|
165.20 SpO2:FiO2
Standard Deviation 62.96
|
189.80 SpO2:FiO2
Standard Deviation 46.50
|
256.67 SpO2:FiO2
Standard Deviation 55.38
|
|
Oxygenation - Pulse Oximetry
Day 1, Prior to Dose 2
|
252.98 SpO2:FiO2
Standard Deviation 87.49
|
165.35 SpO2:FiO2
Standard Deviation 63.48
|
188.84 SpO2:FiO2
Standard Deviation 45.79
|
255.95 SpO2:FiO2
Standard Deviation 56.01
|
|
Oxygenation - Pulse Oximetry
Day 1, Prior to Dose 3
|
253.23 SpO2:FiO2
Standard Deviation 89.57
|
166.17 SpO2:FiO2
Standard Deviation 61.57
|
189.86 SpO2:FiO2
Standard Deviation 43.19
|
255.72 SpO2:FiO2
Standard Deviation 54.41
|
|
Oxygenation - Pulse Oximetry
Day 1, Prior to Dose 4
|
252.47 SpO2:FiO2
Standard Deviation 88.97
|
165.83 SpO2:FiO2
Standard Deviation 64.40
|
189.40 SpO2:FiO2
Standard Deviation 44.72
|
255.78 SpO2:FiO2
Standard Deviation 55.36
|
|
Oxygenation - Pulse Oximetry
Day 2, Prior to Dose 1
|
274.90 SpO2:FiO2
Standard Deviation 118.47
|
165.32 SpO2:FiO2
Standard Deviation 63.52
|
207.80 SpO2:FiO2
Standard Deviation 30.76
|
275.20 SpO2:FiO2
Standard Deviation 51.66
|
|
Oxygenation - Pulse Oximetry
Day 2, 1 Minute Post Dose 1
|
270.90 SpO2:FiO2
Standard Deviation 118.00
|
165.98 SpO2:FiO2
Standard Deviation 63.00
|
202.00 SpO2:FiO2
Standard Deviation 33.54
|
—
|
|
Oxygenation - Pulse Oximetry
Day 2, Prior to Dose 2
|
303.17 SpO2:FiO2
Standard Deviation 147.94
|
172.12 SpO2:FiO2
Standard Deviation 93.68
|
201.52 SpO2:FiO2
Standard Deviation 39.10
|
267.90 SpO2:FiO2
Standard Deviation 58.71
|
|
Oxygenation - Pulse Oximetry
Day 2, Prior to Dose 3
|
300.43 SpO2:FiO2
Standard Deviation 146.10
|
173.68 SpO2:FiO2
Standard Deviation 94.74
|
204.42 SpO2:FiO2
Standard Deviation 49.32
|
267.57 SpO2:FiO2
Standard Deviation 56.69
|
|
Oxygenation - Pulse Oximetry
Day 2, Prior to Dose 4
|
300.40 SpO2:FiO2
Standard Deviation 147.32
|
174.33 SpO2:FiO2
Standard Deviation 96.09
|
215.25 SpO2:FiO2
Standard Deviation 39.84
|
266.48 SpO2:FiO2
Standard Deviation 55.31
|
|
Oxygenation - Pulse Oximetry
Day 3, Prior to Dose 1
|
265.12 SpO2:FiO2
Standard Deviation 121.86
|
174.08 SpO2:FiO2
Standard Deviation 95.67
|
247.23 SpO2:FiO2
Standard Deviation 65.92
|
270.38 SpO2:FiO2
Standard Deviation 71.65
|
|
Oxygenation - Pulse Oximetry
Day 3, 1 Minute Post Dose 1
|
265.57 SpO2:FiO2
Standard Deviation 121.88
|
174.08 SpO2:FiO2
Standard Deviation 95.67
|
245.97 SpO2:FiO2
Standard Deviation 71.98
|
—
|
|
Oxygenation - Pulse Oximetry
Day 3, Prior to Dose 2
|
265.47 SpO2:FiO2
Standard Deviation 121.09
|
174.50 SpO2:FiO2
Standard Deviation 93.34
|
248.12 SpO2:FiO2
Standard Deviation 66.38
|
271.20 SpO2:FiO2
Standard Deviation 71.78
|
|
Oxygenation - Pulse Oximetry
Day 3, Prior to Dose 3
|
266.68 SpO2:FiO2
Standard Deviation 120.38
|
175.05 SpO2:FiO2
Standard Deviation 95.16
|
254.85 SpO2:FiO2
Standard Deviation 60.32
|
271.70 SpO2:FiO2
Standard Deviation 72.17
|
|
Oxygenation - Pulse Oximetry
Day 3, Prior to Dose 4
|
260.48 SpO2:FiO2
Standard Deviation 121.26
|
175.18 SpO2:FiO2
Standard Deviation 95.25
|
259.87 SpO2:FiO2
Standard Deviation 52.29
|
279.78 SpO2:FiO2
Standard Deviation 67.28
|
|
Oxygenation - Pulse Oximetry
Day 4, Prior to Dose 1
|
305.20 SpO2:FiO2
Standard Deviation 147.31
|
179.77 SpO2:FiO2
Standard Deviation 95.57
|
286.12 SpO2:FiO2
Standard Deviation 95.93
|
321.28 SpO2:FiO2
Standard Deviation 69.97
|
|
Oxygenation - Pulse Oximetry
Day 4, Prior to Dose 2
|
304.03 SpO2:FiO2
Standard Deviation 145.69
|
176.32 SpO2:FiO2
Standard Deviation 87.93
|
264.70 SpO2:FiO2
Standard Deviation 51.29
|
322.13 SpO2:FiO2
Standard Deviation 71.91
|
|
Oxygenation - Pulse Oximetry
Day 4, Prior to Dose 3
|
303.78 SpO2:FiO2
Standard Deviation 144.73
|
176.32 SpO2:FiO2
Standard Deviation 87.96
|
266.77 SpO2:FiO2
Standard Deviation 53.24
|
320.35 SpO2:FiO2
Standard Deviation 70.77
|
|
Oxygenation - Pulse Oximetry
Day 4, Prior to Dose 4
|
303.85 SpO2:FiO2
Standard Deviation 143.53
|
177.28 SpO2:FiO2
Standard Deviation 89.45
|
302.93 SpO2:FiO2
Standard Deviation 91.27
|
335.45 SpO2:FiO2
Standard Deviation 59.25
|
|
Oxygenation - Pulse Oximetry
Day 5, Prior to Dose 1
|
288.23 SpO2:FiO2
Standard Deviation 151.89
|
176.55 SpO2:FiO2
Standard Deviation 90.15
|
301.43 SpO2:FiO2
Standard Deviation 91.31
|
343.87 SpO2:FiO2
Standard Deviation 57.80
|
|
Oxygenation - Pulse Oximetry
Day 5, Prior to Dose 2
|
288.03 SpO2:FiO2
Standard Deviation 152.74
|
175.73 SpO2:FiO2
Standard Deviation 88.43
|
316.25 SpO2:FiO2
Standard Deviation 85.00
|
344.85 SpO2:FiO2
Standard Deviation 56.57
|
|
Oxygenation - Pulse Oximetry
Day 5, Prior to Dose 3
|
287.75 SpO2:FiO2
Standard Deviation 151.69
|
176.88 SpO2:FiO2
Standard Deviation 89.80
|
314.82 SpO2:FiO2
Standard Deviation 82.17
|
355.35 SpO2:FiO2
Standard Deviation 63.60
|
|
Oxygenation - Pulse Oximetry
Day 5, Prior to Dose 4
|
288.23 SpO2:FiO2
Standard Deviation 151.77
|
184.67 SpO2:FiO2
Standard Deviation 102.13
|
297.18 SpO2:FiO2
Standard Deviation 45.15
|
348.40 SpO2:FiO2
Standard Deviation 75.66
|
|
Oxygenation - Pulse Oximetry
Day 6, Prior to Dose 1
|
277.96 SpO2:FiO2
Standard Deviation 175.22
|
189.23 SpO2:FiO2
Standard Deviation 108.10
|
343.86 SpO2:FiO2
Standard Deviation 68.07
|
341.25 SpO2:FiO2
Standard Deviation 87.32
|
|
Oxygenation - Pulse Oximetry
Day 6, Prior to Dose 2
|
303.55 SpO2:FiO2
Standard Deviation 237.38
|
232.48 SpO2:FiO2
Standard Deviation 138.43
|
322.44 SpO2:FiO2
Standard Deviation 29.39
|
340.63 SpO2:FiO2
Standard Deviation 90.97
|
|
Oxygenation - Pulse Oximetry
Day 6, Prior to Dose 3
|
298.80 SpO2:FiO2
Standard Deviation 230.66
|
233.93 SpO2:FiO2
Standard Deviation 140.79
|
322.28 SpO2:FiO2
Standard Deviation 27.37
|
356.63 SpO2:FiO2
Standard Deviation 111.05
|
|
Oxygenation - Pulse Oximetry
Day 6, Prior to Dose 4
|
301.90 SpO2:FiO2
Standard Deviation 233.06
|
232.73 SpO2:FiO2
Standard Deviation 138.10
|
343.38 SpO2:FiO2
Standard Deviation 69.97
|
415.68 SpO2:FiO2
Standard Deviation 95.68
|
|
Oxygenation - Pulse Oximetry
Day 7, Prior to Dose 1
|
223.05 SpO2:FiO2
Standard Deviation 99.73
|
236.05 SpO2:FiO2
Standard Deviation 179.16
|
341.35 SpO2:FiO2
Standard Deviation 67.98
|
433.48 SpO2:FiO2
Standard Deviation 79.04
|
|
Oxygenation - Pulse Oximetry
Day 7, Prior to Dose 2
|
218.85 SpO2:FiO2
Standard Deviation 123.67
|
232.17 SpO2:FiO2
Standard Deviation 212.20
|
371.78 SpO2:FiO2
Standard Deviation 57.66
|
402.50 SpO2:FiO2
Standard Deviation 115.29
|
|
Oxygenation - Pulse Oximetry
Day 7, Prior to Dose 3
|
218.15 SpO2:FiO2
Standard Deviation 124.66
|
223.37 SpO2:FiO2
Standard Deviation 217.08
|
340.00 SpO2:FiO2
Standard Deviation 11.55
|
403.43 SpO2:FiO2
Standard Deviation 113.68
|
|
Oxygenation - Pulse Oximetry
Day 7, Prior to Dose 4
|
219.60 SpO2:FiO2
Standard Deviation 122.61
|
226.13 SpO2:FiO2
Standard Deviation 214.31
|
401.85 SpO2:FiO2
Standard Deviation 70.12
|
411.63 SpO2:FiO2
Standard Deviation 91.25
|
|
Oxygenation - Pulse Oximetry
Day 8, Prior to Dose 1
|
300.37 SpO2:FiO2
Standard Deviation 164.58
|
187.60 SpO2:FiO2
Standard Deviation 156.67
|
378.26 SpO2:FiO2
Standard Deviation 85.71
|
425.80 SpO2:FiO2
Standard Deviation 81.80
|
|
Oxygenation - Pulse Oximetry
Day 8, Prior to Dose 2
|
220.30 SpO2:FiO2
Standard Deviation 121.62
|
233.23 SpO2:FiO2
Standard Deviation 206.81
|
422.60 SpO2:FiO2
Standard Deviation 59.76
|
306.30 SpO2:FiO2
|
|
Oxygenation - Pulse Oximetry
Day 8, Prior to Dose 3
|
216.55 SpO2:FiO2
Standard Deviation 122.40
|
248.03 SpO2:FiO2
Standard Deviation 193.52
|
385.00 SpO2:FiO2
Standard Deviation 75.75
|
306.30 SpO2:FiO2
|
|
Oxygenation - Pulse Oximetry
Day 8, Prior to Dose 4
|
219.70 SpO2:FiO2
Standard Deviation 126.85
|
246.00 SpO2:FiO2
Standard Deviation 191.24
|
410.15 SpO2:FiO2
Standard Deviation 79.97
|
461.90 SpO2:FiO2
|
|
Oxygenation - Pulse Oximetry
Day 9, Prior to Dose 1
|
294.75 SpO2:FiO2
Standard Deviation 229.60
|
221.45 SpO2:FiO2
Standard Deviation 166.65
|
395.48 SpO2:FiO2
Standard Deviation 79.54
|
461.90 SpO2:FiO2
|
|
Oxygenation - Pulse Oximetry
Day 9, Prior to Dose 2
|
291.25 SpO2:FiO2
Standard Deviation 234.55
|
248.47 SpO2:FiO2
Standard Deviation 189.04
|
398.35 SpO2:FiO2
Standard Deviation 96.66
|
457.10 SpO2:FiO2
|
|
Oxygenation - Pulse Oximetry
Day 9, Prior to Dose 3
|
293.35 SpO2:FiO2
Standard Deviation 231.58
|
149.95 SpO2:FiO2
Standard Deviation 18.88
|
395.95 SpO2:FiO2
Standard Deviation 93.27
|
457.10 SpO2:FiO2
|
|
Oxygenation - Pulse Oximetry
Day 9, Prior to Dose 4
|
291.70 SpO2:FiO2
Standard Deviation 227.26
|
158.10 SpO2:FiO2
Standard Deviation 28.43
|
471.40 SpO2:FiO2
Standard Deviation 0.00
|
457.10 SpO2:FiO2
|
|
Oxygenation - Pulse Oximetry
Day 10, Prior to Dose 1
|
213.80 SpO2:FiO2
Standard Deviation 130.81
|
154.67 SpO2:FiO2
Standard Deviation 23.93
|
395.03 SpO2:FiO2
Standard Deviation 82.81
|
457.10 SpO2:FiO2
|
|
Oxygenation - Pulse Oximetry
Day 10, Prior to Dose 2
|
214.50 SpO2:FiO2
Standard Deviation 129.82
|
159.20 SpO2:FiO2
Standard Deviation 31.96
|
394.30 SpO2:FiO2
Standard Deviation 95.60
|
452.40 SpO2:FiO2
|
|
Oxygenation - Pulse Oximetry
Day 10, Prior to Dose 3
|
122.70 SpO2:FiO2
|
159.90 SpO2:FiO2
Standard Deviation 30.97
|
469.05 SpO2:FiO2
Standard Deviation 3.32
|
461.90 SpO2:FiO2
|
|
Oxygenation - Pulse Oximetry
Day 10, Prior to Dose 4
|
122.70 SpO2:FiO2
|
158.50 SpO2:FiO2
Standard Deviation 32.95
|
469.05 SpO2:FiO2
Standard Deviation 3.32
|
466.70 SpO2:FiO2
|
Adverse Events
Lead-in 0.25 mg/kg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Lead-in 0.50 mg/kg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Lead-in 1.0 mg/kg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Lead-in 1.5 mg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lead-in 0.25 mg/kg
n=6 participants at risk
0.25 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days
Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
|
Lead-in 0.50 mg/kg
n=6 participants at risk
0.50 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days
Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
|
Lead-in 1.0 mg/kg
n=7 participants at risk
1.0 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days
Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
|
Lead-in 1.5 mg/kg
n=6 participants at risk
1.5 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days
Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
16.7%
1/6 • Number of events 1 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
16.7%
1/6 • Number of events 1 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/7 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
Other adverse events
| Measure |
Lead-in 0.25 mg/kg
n=6 participants at risk
0.25 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days
Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
|
Lead-in 0.50 mg/kg
n=6 participants at risk
0.50 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days
Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
|
Lead-in 1.0 mg/kg
n=7 participants at risk
1.0 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days
Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
|
Lead-in 1.5 mg/kg
n=6 participants at risk
1.5 mg/kg TSC, administered via IV bolus every 6 hours for up to 15 days
Trans Sodium Crocetinate: TSC, at the optimum safe and tolerable dose determined in the lead-in phase, administered via IV bolus every 6 hours for up to 15 days
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
14.3%
1/7 • Number of events 1 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
14.3%
1/7 • Number of events 1 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
|
Cardiac disorders
Congestive Cardiomyopathy
|
16.7%
1/6 • Number of events 1 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/7 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
|
Ear and labyrinth disorders
Excessive Cerumen Production
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
14.3%
1/7 • Number of events 1 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
16.7%
1/6 • Number of events 1 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/7 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6 • Number of events 1 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/7 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
|
Gastrointestinal disorders
Hernial Eventration
|
16.7%
1/6 • Number of events 1 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/7 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
|
Gastrointestinal disorders
Hiatus Hernia
|
16.7%
1/6 • Number of events 1 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
16.7%
1/6 • Number of events 1 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/7 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/7 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/7 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
14.3%
1/7 • Number of events 1 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
|
General disorders
Oedema Peripheral
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
16.7%
1/6 • Number of events 1 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/7 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
|
Hepatobiliary disorders
Hepatic Steatosis
|
16.7%
1/6 • Number of events 1 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/7 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
|
Hepatobiliary disorders
Hepatocellular Injury
|
16.7%
1/6 • Number of events 1 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/7 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
14.3%
1/7 • Number of events 1 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
|
Infections and infestations
Oral Candidiasis
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
16.7%
1/6 • Number of events 1 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/7 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
|
Infections and infestations
Pneumonia Bacterial
|
16.7%
1/6 • Number of events 1 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/7 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
|
Infections and infestations
Respiratory Tract Infection Bacterial
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
16.7%
1/6 • Number of events 1 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/7 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
|
Infections and infestations
Respiratory Tract Infection Fungal
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
16.7%
1/6 • Number of events 1 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/7 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
16.7%
1/6 • Number of events 1 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/7 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
|
Infections and infestations
Superinfection Bacterial
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
16.7%
1/6 • Number of events 1 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/7 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
|
Infections and infestations
Urinary Tract Infection Fungal
|
16.7%
1/6 • Number of events 1 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/7 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
33.3%
2/6 • Number of events 2 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/7 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
16.7%
1/6 • Number of events 1 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/7 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
|
Investigations
Electrocardiogram QT Prolonged
|
16.7%
1/6 • Number of events 1 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/7 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/7 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
16.7%
1/6 • Number of events 1 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
16.7%
1/6 • Number of events 2 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/7 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
16.7%
1/6 • Number of events 1 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/7 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
16.7%
1/6 • Number of events 1 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
16.7%
1/6 • Number of events 1 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/7 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
|
Metabolism and nutrition disorders
Oedema Peripheral
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
16.7%
1/6 • Number of events 1 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/7 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
14.3%
1/7 • Number of events 1 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
|
Psychiatric disorders
Depression
|
16.7%
1/6 • Number of events 1 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/7 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/7 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
16.7%
1/6 • Number of events 1 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
14.3%
1/7 • Number of events 2 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
|
Renal and urinary disorders
Urinary Retention
|
16.7%
1/6 • Number of events 1 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/7 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
16.7%
1/6 • Number of events 1 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/7 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
50.0%
3/6 • Number of events 3 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/7 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/7 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
16.7%
1/6 • Number of events 1 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
16.7%
1/6 • Number of events 1 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/7 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
16.7%
1/6 • Number of events 1 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/7 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
14.3%
1/7 • Number of events 1 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
14.3%
1/7 • Number of events 1 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/6 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
0.00%
0/7 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
16.7%
1/6 • Number of events 1 • AEs were collected for up to 70 days from the start of study drug administration through the 60-day follow-up visit (+10d).
Phase 1 lead-in was conducted; however, the study was completed prior to initiation of Phase 2. Therefore, only data are reported for the lead-in phase, as no data were collected for Phase 2.
|
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