Trial Outcomes & Findings for TD-0903 for ALI Associated With COVID-19 (NCT NCT04402866)
NCT ID: NCT04402866
Last Updated: 2022-03-17
Results Overview
An RFD was defined as a day that a participant was alive and did not require the use of any respiratory support (invasive mechanical ventilation, non-invasive positive pressure ventilation, high-flow oxygen devices, or oxygen supplementation) from randomization through Day 28. The number of RFDs was 0 for participants who used respiratory support for 28 days or longer or for participants who died on or before Day 28. A clinical status score of ≤ 4 on a given day was equivalent to an RFD. The clinical status categories and associated scores ranged from 1-8 where a higher score represented a worse outcome. A clinical status score of 4 was defined as a participant who was hospitalized, not requiring supplemental oxygen, but requiring ongoing medical care (whether or not related to COVID-19).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
235 participants
Primary outcome timeframe
Randomization to Day 28
Results posted on
2022-03-17
Participant Flow
235 participants were enrolled across 24 sites in the United States, Brazil, Finland, the Republic of Moldova, Romania, Ukraine and the United Kingdom.
235 participants were enrolled and 230 participants were randomized and treated with study drug. Within each cohort in Part 1 (multiple-ascending dose design), participants were randomized 3:1, TD-0903 to placebo. During Part 2 (parallel-group design), participants were stratified by baseline age (≤ 60 versus \> 60 years), and by concurrent use of antiviral medications (yes or no) at baseline. Within each stratum, participants were randomized 1:1 to receive either TD-0903 or placebo.
Participant milestones
| Measure |
Part 1: Matching Placebo
Matching placebo inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system.
|
Part 1: TD-0903 - 1 mg
TD-0903 inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system at a dose of 1 mg. Participants were administered a 2 mg loading dose as the total dose on Day 1.
|
Part 1: TD-0903 - 3 mg
TD-0903 inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system at a dose of 3 mg. Participants were administered a 6 mg loading dose as the total dose on Day 1.
|
Part 1: TD-0903 - 10 mg
TD-0903 inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system at a dose of 10 mg.
|
Part 2: Matching Placebo
Matching placebo inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system.
|
Part 2: TD-0903 - 3 mg
TD-0903 inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system at a dose of 3 mg. Participants were administered a 6 mg loading dose as the total dose on Day 1.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
7
|
6
|
104
|
106
|
|
Overall Study
Randomized and Treated With Study Drug
|
6
|
6
|
7
|
6
|
102
|
103
|
|
Overall Study
COMPLETED
|
4
|
5
|
6
|
6
|
89
|
92
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
1
|
0
|
15
|
14
|
Reasons for withdrawal
| Measure |
Part 1: Matching Placebo
Matching placebo inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system.
|
Part 1: TD-0903 - 1 mg
TD-0903 inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system at a dose of 1 mg. Participants were administered a 2 mg loading dose as the total dose on Day 1.
|
Part 1: TD-0903 - 3 mg
TD-0903 inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system at a dose of 3 mg. Participants were administered a 6 mg loading dose as the total dose on Day 1.
|
Part 1: TD-0903 - 10 mg
TD-0903 inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system at a dose of 10 mg.
|
Part 2: Matching Placebo
Matching placebo inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system.
|
Part 2: TD-0903 - 3 mg
TD-0903 inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system at a dose of 3 mg. Participants were administered a 6 mg loading dose as the total dose on Day 1.
|
|---|---|---|---|---|---|---|
|
Overall Study
Discontinued Prior to Treatment
|
0
|
0
|
0
|
0
|
2
|
3
|
|
Overall Study
Adverse Event
|
2
|
1
|
0
|
0
|
13
|
8
|
|
Overall Study
Miscellaneous
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
2
|
Baseline Characteristics
TD-0903 for ALI Associated With COVID-19
Baseline characteristics by cohort
| Measure |
Part 1: Matching Placebo
n=6 Participants
Matching placebo inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system.
|
Part 1: TD-0903 - 1 mg
n=6 Participants
TD-0903 inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system at a dose of 1 mg. Participants were administered a 2 mg loading dose as the total dose on Day 1.
|
Part 1: TD-0903 - 3 mg
n=7 Participants
TD-0903 inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system at a dose of 3 mg. Participants were administered a 6 mg loading dose as the total dose on Day 1.
|
Part 1: TD-0903 - 10 mg
n=6 Participants
TD-0903 inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system at a dose of 10 mg.
|
Part 2: Matching Placebo
n=104 Participants
Matching placebo inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system.
|
Part 2: TD-0903 - 3 mg
n=106 Participants
TD-0903 inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system at a dose of 3 mg. Participants were administered a 6 mg loading dose as the total dose on Day 1.
|
Total
n=235 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
70 Participants
n=21 Participants
|
60 Participants
n=8 Participants
|
146 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
46 Participants
n=8 Participants
|
89 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
41 Participants
n=8 Participants
|
90 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
63 Participants
n=21 Participants
|
65 Participants
n=8 Participants
|
145 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
24 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
90 Participants
n=21 Participants
|
89 Participants
n=8 Participants
|
204 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
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
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
102 Participants
n=21 Participants
|
104 Participants
n=8 Participants
|
230 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Randomization to Day 28Population: ITT analysis set (Part 2) - all participants with analyzable data who were randomized into the study.
An RFD was defined as a day that a participant was alive and did not require the use of any respiratory support (invasive mechanical ventilation, non-invasive positive pressure ventilation, high-flow oxygen devices, or oxygen supplementation) from randomization through Day 28. The number of RFDs was 0 for participants who used respiratory support for 28 days or longer or for participants who died on or before Day 28. A clinical status score of ≤ 4 on a given day was equivalent to an RFD. The clinical status categories and associated scores ranged from 1-8 where a higher score represented a worse outcome. A clinical status score of 4 was defined as a participant who was hospitalized, not requiring supplemental oxygen, but requiring ongoing medical care (whether or not related to COVID-19).
Outcome measures
| Measure |
Part 2: Matching Placebo
n=102 Participants
Matching placebo inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system.
|
Part 2: TD-0903 - 3 mg
n=100 Participants
TD-0903 inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system at a dose of 3 mg. Participants were administered a 6 mg loading dose as the total dose on Day 1.
|
|---|---|---|
|
Part 2: Number of Respiratory Failure-free Days (RFDs) From Randomization to Day 28
|
21.0 days
Interval 15.0 to 23.0
|
21.0 days
Interval 17.5 to 23.0
|
SECONDARY outcome
Timeframe: Baseline and Day 7Population: ITT analysis set (Part 2) - all participants with analyzable data who were randomized into the study.
SaO2/FiO2 ratio was calculated as SaO2 divided by FiO2.
Outcome measures
| Measure |
Part 2: Matching Placebo
n=86 Participants
Matching placebo inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system.
|
Part 2: TD-0903 - 3 mg
n=90 Participants
TD-0903 inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system at a dose of 3 mg. Participants were administered a 6 mg loading dose as the total dose on Day 1.
|
|---|---|---|
|
Part 2: Change From Baseline in SaO2/FiO2 Ratio on Day 7
|
88.97 ratio measure
Standard Error 7.769
|
88.46 ratio measure
Standard Error 7.654
|
SECONDARY outcome
Timeframe: Days 7, 14, 21 and 28Population: ITT analysis set (Part 2) - all participants with analyzable data who were randomized into the study.
The clinical status categories and associated scores ranged from 1-8 where a higher score represented a worse outcome. The scale was as follows: * Score 1: Not hospitalized, no limitations on activities * Score 2: Not hospitalized, but with limitations on activities and/or requiring home oxygen * Score 3: Hospitalized, not requiring supplemental oxygen, and no longer requiring ongoing medical care * Score 4: Hospitalized, not requiring supplemental oxygen, but requiring ongoing medical care (whether or not related to COVID-19) * Score 5: Hospitalized, requiring supplemental oxygen * Score 6: Hospitalized, on non-invasive ventilation or high-flow oxygen devices * Score 7: Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation * Score 8: Death
Outcome measures
| Measure |
Part 2: Matching Placebo
n=102 Participants
Matching placebo inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system.
|
Part 2: TD-0903 - 3 mg
n=100 Participants
TD-0903 inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system at a dose of 3 mg. Participants were administered a 6 mg loading dose as the total dose on Day 1.
|
|---|---|---|
|
Part 2: Number of Participants in Each Category of the 8-point Ordinal Clinical Status Scale on Days 7, 14, 21, and 28
Day 7 · Score 1
|
6 Participants
|
8 Participants
|
|
Part 2: Number of Participants in Each Category of the 8-point Ordinal Clinical Status Scale on Days 7, 14, 21, and 28
Day 7 · Score 2
|
12 Participants
|
9 Participants
|
|
Part 2: Number of Participants in Each Category of the 8-point Ordinal Clinical Status Scale on Days 7, 14, 21, and 28
Day 7 · Score 3
|
1 Participants
|
1 Participants
|
|
Part 2: Number of Participants in Each Category of the 8-point Ordinal Clinical Status Scale on Days 7, 14, 21, and 28
Day 7 · Score 4
|
25 Participants
|
23 Participants
|
|
Part 2: Number of Participants in Each Category of the 8-point Ordinal Clinical Status Scale on Days 7, 14, 21, and 28
Day 7 · Score 5
|
42 Participants
|
48 Participants
|
|
Part 2: Number of Participants in Each Category of the 8-point Ordinal Clinical Status Scale on Days 7, 14, 21, and 28
Day 7 · Score 6
|
7 Participants
|
7 Participants
|
|
Part 2: Number of Participants in Each Category of the 8-point Ordinal Clinical Status Scale on Days 7, 14, 21, and 28
Day 7 · Score 7
|
7 Participants
|
2 Participants
|
|
Part 2: Number of Participants in Each Category of the 8-point Ordinal Clinical Status Scale on Days 7, 14, 21, and 28
Day 7 · Score 8
|
2 Participants
|
1 Participants
|
|
Part 2: Number of Participants in Each Category of the 8-point Ordinal Clinical Status Scale on Days 7, 14, 21, and 28
Day 14 · Score 1
|
57 Participants
|
52 Participants
|
|
Part 2: Number of Participants in Each Category of the 8-point Ordinal Clinical Status Scale on Days 7, 14, 21, and 28
Day 14 · Score 2
|
6 Participants
|
11 Participants
|
|
Part 2: Number of Participants in Each Category of the 8-point Ordinal Clinical Status Scale on Days 7, 14, 21, and 28
Day 14 · Score 3
|
2 Participants
|
7 Participants
|
|
Part 2: Number of Participants in Each Category of the 8-point Ordinal Clinical Status Scale on Days 7, 14, 21, and 28
Day 14 · Score 4
|
14 Participants
|
13 Participants
|
|
Part 2: Number of Participants in Each Category of the 8-point Ordinal Clinical Status Scale on Days 7, 14, 21, and 28
Day 14 · Score 5
|
10 Participants
|
7 Participants
|
|
Part 2: Number of Participants in Each Category of the 8-point Ordinal Clinical Status Scale on Days 7, 14, 21, and 28
Day 14 · Score 6
|
1 Participants
|
2 Participants
|
|
Part 2: Number of Participants in Each Category of the 8-point Ordinal Clinical Status Scale on Days 7, 14, 21, and 28
Day 14 · Score 7
|
6 Participants
|
5 Participants
|
|
Part 2: Number of Participants in Each Category of the 8-point Ordinal Clinical Status Scale on Days 7, 14, 21, and 28
Day 14 · Score 8
|
6 Participants
|
2 Participants
|
|
Part 2: Number of Participants in Each Category of the 8-point Ordinal Clinical Status Scale on Days 7, 14, 21, and 28
Day 21 · Score 1
|
72 Participants
|
72 Participants
|
|
Part 2: Number of Participants in Each Category of the 8-point Ordinal Clinical Status Scale on Days 7, 14, 21, and 28
Day 21 · Score 2
|
4 Participants
|
9 Participants
|
|
Part 2: Number of Participants in Each Category of the 8-point Ordinal Clinical Status Scale on Days 7, 14, 21, and 28
Day 21 · Score 3
|
4 Participants
|
6 Participants
|
|
Part 2: Number of Participants in Each Category of the 8-point Ordinal Clinical Status Scale on Days 7, 14, 21, and 28
Day 21 · Score 4
|
4 Participants
|
0 Participants
|
|
Part 2: Number of Participants in Each Category of the 8-point Ordinal Clinical Status Scale on Days 7, 14, 21, and 28
Day 21 · Score 5
|
3 Participants
|
4 Participants
|
|
Part 2: Number of Participants in Each Category of the 8-point Ordinal Clinical Status Scale on Days 7, 14, 21, and 28
Day 21 · Score 6
|
1 Participants
|
0 Participants
|
|
Part 2: Number of Participants in Each Category of the 8-point Ordinal Clinical Status Scale on Days 7, 14, 21, and 28
Day 21 · Score 7
|
2 Participants
|
3 Participants
|
|
Part 2: Number of Participants in Each Category of the 8-point Ordinal Clinical Status Scale on Days 7, 14, 21, and 28
Day 21 · Score 8
|
12 Participants
|
5 Participants
|
|
Part 2: Number of Participants in Each Category of the 8-point Ordinal Clinical Status Scale on Days 7, 14, 21, and 28
Day 28 · Score 1
|
79 Participants
|
78 Participants
|
|
Part 2: Number of Participants in Each Category of the 8-point Ordinal Clinical Status Scale on Days 7, 14, 21, and 28
Day 28 · Score 2
|
5 Participants
|
11 Participants
|
|
Part 2: Number of Participants in Each Category of the 8-point Ordinal Clinical Status Scale on Days 7, 14, 21, and 28
Day 28 · Score 3
|
0 Participants
|
1 Participants
|
|
Part 2: Number of Participants in Each Category of the 8-point Ordinal Clinical Status Scale on Days 7, 14, 21, and 28
Day 28 · Score 4
|
1 Participants
|
1 Participants
|
|
Part 2: Number of Participants in Each Category of the 8-point Ordinal Clinical Status Scale on Days 7, 14, 21, and 28
Day 28 · Score 5
|
3 Participants
|
1 Participants
|
|
Part 2: Number of Participants in Each Category of the 8-point Ordinal Clinical Status Scale on Days 7, 14, 21, and 28
Day 28 · Score 6
|
0 Participants
|
0 Participants
|
|
Part 2: Number of Participants in Each Category of the 8-point Ordinal Clinical Status Scale on Days 7, 14, 21, and 28
Day 28 · Score 7
|
1 Participants
|
2 Participants
|
|
Part 2: Number of Participants in Each Category of the 8-point Ordinal Clinical Status Scale on Days 7, 14, 21, and 28
Day 28 · Score 8
|
13 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Day 28Population: ITT analysis set (Part 2) - all participants with analyzable data who were randomized into the study.
Defined as participants who were alive and did not require the use of any respiratory support (invasive mechanical ventilation, non-invasive positive pressure ventilation, high-flow oxygen devices, or oxygen supplementation) on Day 28.
Outcome measures
| Measure |
Part 2: Matching Placebo
n=104 Participants
Matching placebo inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system.
|
Part 2: TD-0903 - 3 mg
n=106 Participants
TD-0903 inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system at a dose of 3 mg. Participants were administered a 6 mg loading dose as the total dose on Day 1.
|
|---|---|---|
|
Part 2: Number of Participants Alive and Respiratory Failure-free on Day 28
|
85 Participants
|
92 Participants
|
Adverse Events
Part 1: Matching Placebo
Serious events: 3 serious events
Other events: 6 other events
Deaths: 2 deaths
Part 1: TD-0903 - 1 mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
Part 1: TD-0903 - 3 mg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1: TD-0903 - 10 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 2: Matching Placebo
Serious events: 16 serious events
Other events: 18 other events
Deaths: 13 deaths
Part 2: TD-0903 - 3 mg
Serious events: 10 serious events
Other events: 15 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Part 1: Matching Placebo
n=6 participants at risk
Matching placebo inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system.
|
Part 1: TD-0903 - 1 mg
n=6 participants at risk
TD-0903 inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system at a dose of 1 mg.
|
Part 1: TD-0903 - 3 mg
n=7 participants at risk
TD-0903 inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system at a dose of 3 mg.
|
Part 1: TD-0903 - 10 mg
n=6 participants at risk
TD-0903 inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system at a dose of 10 mg.
|
Part 2: Matching Placebo
n=102 participants at risk
Matching placebo inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system.
|
Part 2: TD-0903 - 3 mg
n=103 participants at risk
TD-0903 inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system. Participants were administered the recommended dose of 3 mg based on the data from Part 1.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
16.7%
1/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
33.3%
2/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
2.9%
3/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
General disorders
Multiple organ dysfunction syndrome
|
16.7%
1/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
16.7%
1/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.98%
1/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
2.9%
3/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac arrest
|
16.7%
1/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
2.0%
2/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
16.7%
1/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
2.9%
3/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
16.7%
1/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
14.3%
1/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.97%
1/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.98%
1/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.97%
1/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
2.9%
3/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
Infections and infestations
Septic shock
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.98%
1/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
Vascular disorders
Shock
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
2.0%
2/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.97%
1/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
3.9%
4/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
4.9%
5/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
2.9%
3/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.98%
1/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.98%
1/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.97%
1/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
General disorders
Sudden death
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.98%
1/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
Infections and infestations
Systemic bacterial infection
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.97%
1/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.97%
1/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.97%
1/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Part 1: Matching Placebo
n=6 participants at risk
Matching placebo inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system.
|
Part 1: TD-0903 - 1 mg
n=6 participants at risk
TD-0903 inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system at a dose of 1 mg.
|
Part 1: TD-0903 - 3 mg
n=7 participants at risk
TD-0903 inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system at a dose of 3 mg.
|
Part 1: TD-0903 - 10 mg
n=6 participants at risk
TD-0903 inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system at a dose of 10 mg.
|
Part 2: Matching Placebo
n=102 participants at risk
Matching placebo inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system.
|
Part 2: TD-0903 - 3 mg
n=103 participants at risk
TD-0903 inhalation solution (1 mL) was administered once daily for up to 7 days via oral inhalation using the Aerogen Solo nebulizer system. Participants were administered the recommended dose of 3 mg based on the data from Part 1.
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
50.0%
3/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.98%
1/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
2.9%
3/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
16.7%
1/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
16.7%
1/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.98%
1/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
16.7%
1/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
16.7%
1/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
16.7%
1/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
16.7%
1/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
16.7%
1/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.98%
1/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.97%
1/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.97%
1/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
Nervous system disorders
Tremor
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
16.7%
1/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
16.7%
1/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
Cardiac disorders
Sinus tachycardia
|
16.7%
1/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.97%
1/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Depressed mood
|
16.7%
1/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Depression
|
16.7%
1/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
16.7%
1/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.97%
1/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
14.3%
1/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
2.0%
2/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.97%
1/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
16.7%
1/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
Infections and infestations
Oropharyngeal candidiasis
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
16.7%
1/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
Infections and infestations
Vascular device infection
|
16.7%
1/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
16.7%
1/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
2.0%
2/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
2.9%
3/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.7%
1/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
16.7%
1/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
3.9%
4/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
16.7%
1/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.98%
1/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.97%
1/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
16.7%
1/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
6.9%
7/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
2.9%
3/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.98%
1/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
16.7%
1/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
5.9%
6/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
4.9%
5/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Chronic kidney disease
|
16.7%
1/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/7 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/6 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/102 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
0.00%
0/103 • Day 1 to Day 28
Safety analysis set - all participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place