Trial Outcomes & Findings for A First-in-human Study of Single Doses of PF-07328948 Which is Given to Healthy Adult Participants (NCT NCT05654181)
NCT ID: NCT05654181
Last Updated: 2024-11-05
Results Overview
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An adverse event is considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the study were flagged as TEAEs. The algorithm did not consider any events that started prior to the first dose date. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
Day 1-8 per period, along with the 28-35 day post-final dose follow-up
Results posted on
2024-11-05
Participant Flow
A total of 20 participants were enrolled, and received at least one dose of study intervention.
Participant milestones
| Measure |
PF-07328948 10 mg, PF-07328948 30 mg, PF-07328948 100 mg, Placebo
Participants were assigned to Cohort 1 in four sequences (Sequence: PF-07328948 10 mg, 30 mg, 100 mg, placebo; Sequence: 10 mg, 30 mg, placebo, 300 mg; Sequence: 10 mg, placebo, 100 mg, 300 mg; and Sequence: placebo, 30 mg, 100 mg, 300 mg).
|
PF-07328948 10 mg, PF-07328948 30 mg, Placebo, PF-07328948 300 mg
Participants were assigned to Cohort 1 in four sequences (Sequence: PF-07328948 10 mg, 30 mg, 100 mg, placebo; Sequence: 10 mg, 30 mg, placebo, 300 mg; Sequence: 10 mg, placebo, 100 mg, 300 mg; and Sequence: placebo, 30 mg, 100 mg, 300 mg).
|
PF-07328948 10 mg, Placebo, PF-07328948 100 mg, PF-07328948 300 mg
Participants were assigned to Cohort 1 in four sequences (Sequence: PF-07328948 10 mg, 30 mg, 100 mg, placebo; Sequence: 10 mg, 30 mg, placebo, 300 mg; Sequence: 10 mg, placebo, 100 mg, 300 mg; and Sequence: placebo, 30 mg, 100 mg, 300 mg).
|
Placebo, PF-07328948 30 mg, PF-07328948 100 mg, PF-07328948 300 mg
Participants were assigned to Cohort 1 in four sequences (Sequence: PF-07328948 10 mg, 30 mg, 100 mg, placebo; Sequence: 10 mg, 30 mg, placebo, 300 mg; Sequence: 10 mg, placebo, 100 mg, 300 mg; and Sequence: placebo, 30 mg, 100 mg, 300 mg).
|
PF-07328948 750 mg, PF-07328948 F mg, PF-07328948 G mg, Placebo
Participants assigned to sentinel dose in Cohort 2 Period 1 were terminated after Period 1. (The letters 'F', 'G' and 'H' stand for the planned escalating doses.)
|
Placebo, PF-07328948 F mg, PF-07328948 G mg, PF-07328948 H mg
Participants assigned to sentinel dose in Cohort 2 Period 1 were terminated after Period 1. (The letters 'F', 'G' and 'H' stand for the planned escalating doses.)
|
PF-07328948 300 mg, PF-07328948 750 mg, PF-07328948 1500 mg, PF-07328948 750 mg (Fed)
Participants were assigned to Cohort 3 in four sequences (Sequence: 300 mg, 750 mg, 1500 mg, 750 mg \[fed\]; Sequence: 300 mg, 750 mg, placebo, 750 mg \[fed\]; Sequence: 300 mg, placebo, 1500 mg, placebo \[fed\]; and Sequence: placebo, 750 mg, 1500 mg, 750 mg \[fed\]).
|
PF-07328948 300 mg, PF-07328948 750 mg, Placebo, PF-07328948 750 mg (Fed)
Participants were assigned to Cohort 3 in four sequences (Sequence: 300 mg, 750 mg, 1500 mg, 750 mg \[fed\]; Sequence: 300 mg, 750 mg, placebo, 750 mg \[fed\]; Sequence: 300 mg, placebo, 1500 mg, placebo \[fed\]; and Sequence: placebo, 750 mg, 1500 mg, 750 mg \[fed\]).
|
PF-07328948 300 mg, Placebo, PF-07328948 1500 mg, Placebo (Fed)
Participants were assigned to Cohort 3 in four sequences (Sequence: 300 mg, 750 mg, 1500 mg, 750 mg \[fed\]; Sequence: 300 mg, 750 mg, placebo, 750 mg \[fed\]; Sequence: 300 mg, placebo, 1500 mg, placebo \[fed\]; and Sequence: placebo, 750 mg, 1500 mg, 750 mg \[fed\]).
|
Placebo, PF-07328948 750 mg, PF-07328948 1500 mg, PF-07328948 750 mg (Fed)
Participants were assigned to Cohort 3 in four sequences (Sequence: 300 mg, 750 mg, 1500 mg, 750 mg \[fed\]; Sequence: 300 mg, 750 mg, placebo, 750 mg \[fed\]; Sequence: 300 mg, placebo, 1500 mg, placebo \[fed\]; and Sequence: placebo, 750 mg, 1500 mg, 750 mg \[fed\]).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
2
|
2
|
2
|
1
|
1
|
2
|
3
|
2
|
2
|
|
Overall Study
COMPLETED
|
2
|
2
|
2
|
2
|
0
|
0
|
2
|
1
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
1
|
1
|
0
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
PF-07328948 10 mg, PF-07328948 30 mg, PF-07328948 100 mg, Placebo
Participants were assigned to Cohort 1 in four sequences (Sequence: PF-07328948 10 mg, 30 mg, 100 mg, placebo; Sequence: 10 mg, 30 mg, placebo, 300 mg; Sequence: 10 mg, placebo, 100 mg, 300 mg; and Sequence: placebo, 30 mg, 100 mg, 300 mg).
|
PF-07328948 10 mg, PF-07328948 30 mg, Placebo, PF-07328948 300 mg
Participants were assigned to Cohort 1 in four sequences (Sequence: PF-07328948 10 mg, 30 mg, 100 mg, placebo; Sequence: 10 mg, 30 mg, placebo, 300 mg; Sequence: 10 mg, placebo, 100 mg, 300 mg; and Sequence: placebo, 30 mg, 100 mg, 300 mg).
|
PF-07328948 10 mg, Placebo, PF-07328948 100 mg, PF-07328948 300 mg
Participants were assigned to Cohort 1 in four sequences (Sequence: PF-07328948 10 mg, 30 mg, 100 mg, placebo; Sequence: 10 mg, 30 mg, placebo, 300 mg; Sequence: 10 mg, placebo, 100 mg, 300 mg; and Sequence: placebo, 30 mg, 100 mg, 300 mg).
|
Placebo, PF-07328948 30 mg, PF-07328948 100 mg, PF-07328948 300 mg
Participants were assigned to Cohort 1 in four sequences (Sequence: PF-07328948 10 mg, 30 mg, 100 mg, placebo; Sequence: 10 mg, 30 mg, placebo, 300 mg; Sequence: 10 mg, placebo, 100 mg, 300 mg; and Sequence: placebo, 30 mg, 100 mg, 300 mg).
|
PF-07328948 750 mg, PF-07328948 F mg, PF-07328948 G mg, Placebo
Participants assigned to sentinel dose in Cohort 2 Period 1 were terminated after Period 1. (The letters 'F', 'G' and 'H' stand for the planned escalating doses.)
|
Placebo, PF-07328948 F mg, PF-07328948 G mg, PF-07328948 H mg
Participants assigned to sentinel dose in Cohort 2 Period 1 were terminated after Period 1. (The letters 'F', 'G' and 'H' stand for the planned escalating doses.)
|
PF-07328948 300 mg, PF-07328948 750 mg, PF-07328948 1500 mg, PF-07328948 750 mg (Fed)
Participants were assigned to Cohort 3 in four sequences (Sequence: 300 mg, 750 mg, 1500 mg, 750 mg \[fed\]; Sequence: 300 mg, 750 mg, placebo, 750 mg \[fed\]; Sequence: 300 mg, placebo, 1500 mg, placebo \[fed\]; and Sequence: placebo, 750 mg, 1500 mg, 750 mg \[fed\]).
|
PF-07328948 300 mg, PF-07328948 750 mg, Placebo, PF-07328948 750 mg (Fed)
Participants were assigned to Cohort 3 in four sequences (Sequence: 300 mg, 750 mg, 1500 mg, 750 mg \[fed\]; Sequence: 300 mg, 750 mg, placebo, 750 mg \[fed\]; Sequence: 300 mg, placebo, 1500 mg, placebo \[fed\]; and Sequence: placebo, 750 mg, 1500 mg, 750 mg \[fed\]).
|
PF-07328948 300 mg, Placebo, PF-07328948 1500 mg, Placebo (Fed)
Participants were assigned to Cohort 3 in four sequences (Sequence: 300 mg, 750 mg, 1500 mg, 750 mg \[fed\]; Sequence: 300 mg, 750 mg, placebo, 750 mg \[fed\]; Sequence: 300 mg, placebo, 1500 mg, placebo \[fed\]; and Sequence: placebo, 750 mg, 1500 mg, 750 mg \[fed\]).
|
Placebo, PF-07328948 750 mg, PF-07328948 1500 mg, PF-07328948 750 mg (Fed)
Participants were assigned to Cohort 3 in four sequences (Sequence: 300 mg, 750 mg, 1500 mg, 750 mg \[fed\]; Sequence: 300 mg, 750 mg, placebo, 750 mg \[fed\]; Sequence: 300 mg, placebo, 1500 mg, placebo \[fed\]; and Sequence: placebo, 750 mg, 1500 mg, 750 mg \[fed\]).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A First-in-human Study of Single Doses of PF-07328948 Which is Given to Healthy Adult Participants
Baseline characteristics by cohort
| Measure |
PF-07328948 10 mg, PF-07328948 30 mg, PF-07328948 100 mg, Placebo
n=3 Participants
Participants were assigned to Cohort 1 in four sequences (Sequence: PF-07328948 10 mg, 30 mg, 100 mg, placebo; Sequence: 10 mg, 30 mg, placebo, 300 mg; Sequence: 10 mg, placebo, 100 mg, 300 mg; and Sequence: placebo, 30 mg, 100 mg, 300 mg).
|
PF-07328948 10 mg, PF-07328948 30 mg, Placebo, PF-07328948 300 mg
n=2 Participants
Participants were assigned to Cohort 1 in four sequences (Sequence: PF-07328948 10 mg, 30 mg, 100 mg, placebo; Sequence: 10 mg, 30 mg, placebo, 300 mg; Sequence: 10 mg, placebo, 100 mg, 300 mg; and Sequence: placebo, 30 mg, 100 mg, 300 mg).
|
PF-07328948 10 mg, Placebo, PF-07328948 100 mg, PF-07328948 300 mg
n=2 Participants
Participants were assigned to Cohort 1 in four sequences (Sequence: PF-07328948 10 mg, 30 mg, 100 mg, placebo; Sequence: 10 mg, 30 mg, placebo, 300 mg; Sequence: 10 mg, placebo, 100 mg, 300 mg; and Sequence: placebo, 30 mg, 100 mg, 300 mg).
|
Placebo, PF-07328948 30 mg, PF-07328948 100 mg, PF-07328948 300 mg
n=2 Participants
Participants were assigned to Cohort 1 in four sequences (Sequence: PF-07328948 10 mg, 30 mg, 100 mg, placebo; Sequence: 10 mg, 30 mg, placebo, 300 mg; Sequence: 10 mg, placebo, 100 mg, 300 mg; and Sequence: placebo, 30 mg, 100 mg, 300 mg).
|
PF-07328948 750 mg, PF-07328948 F mg, PF-07328948 G mg, Placebo
n=1 Participants
Participants assigned to sentinel dose in Cohort 2 Period 1 were terminated after Period 1. (The letters 'F', 'G' and 'H' stand for the planned escalating doses.)
|
Placebo, PF-07328948 F mg, PF-07328948 G mg, PF-07328948 H mg
n=1 Participants
Participants assigned to sentinel dose in Cohort 2 Period 1 were terminated after Period 1. (The letters 'F', 'G' and 'H' stand for the planned escalating doses.)
|
PF-07328948 300 mg, PF-07328948 750 mg, PF-07328948 1500 mg, PF-07328948 750 mg (Fed)
n=2 Participants
Participants were assigned to Cohort 3 in four sequences (Sequence: 300 mg, 750 mg, 1500 mg, 750 mg \[fed\]; Sequence: 300 mg, 750 mg, placebo, 750 mg \[fed\]; Sequence: 300 mg, placebo, 1500 mg, placebo \[fed\]; and Sequence: placebo, 750 mg, 1500 mg, 750 mg \[fed\]).
|
PF-07328948 300 mg, PF-07328948 750 mg, Placebo, PF-07328948 750 mg (Fed)
n=3 Participants
Participants were assigned to Cohort 3 in four sequences (Sequence: 300 mg, 750 mg, 1500 mg, 750 mg \[fed\]; Sequence: 300 mg, 750 mg, placebo, 750 mg \[fed\]; Sequence: 300 mg, placebo, 1500 mg, placebo \[fed\]; and Sequence: placebo, 750 mg, 1500 mg, 750 mg \[fed\]).
|
PF-07328948 300 mg, Placebo, PF-07328948 1500 mg, Placebo (Fed)
n=2 Participants
Participants were assigned to Cohort 3 in four sequences (Sequence: 300 mg, 750 mg, 1500 mg, 750 mg \[fed\]; Sequence: 300 mg, 750 mg, placebo, 750 mg \[fed\]; Sequence: 300 mg, placebo, 1500 mg, placebo \[fed\]; and Sequence: placebo, 750 mg, 1500 mg, 750 mg \[fed\]).
|
Placebo, PF-07328948 750 mg, PF-07328948 1500 mg, PF-07328948 750 mg (Fed)
n=2 Participants
Participants were assigned to Cohort 3 in four sequences (Sequence: 300 mg, 750 mg, 1500 mg, 750 mg \[fed\]; Sequence: 300 mg, 750 mg, placebo, 750 mg \[fed\]; Sequence: 300 mg, placebo, 1500 mg, placebo \[fed\]; and Sequence: placebo, 750 mg, 1500 mg, 750 mg \[fed\]).
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
18-44 years
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
13 Participants
n=19 Participants
|
|
Age, Customized
45-60 years
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
2 Participants
|
7 Participants
n=19 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
2 Participants
|
3 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
0 Participants
|
17 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
0 Participants
|
4 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
2 Participants
|
16 Participants
n=19 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
0 Participants
n=19 Participants
|
|
Race/Ethnicity, Customized
White
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
1 Participants
|
5 Participants
n=19 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
1 Participants
|
9 Participants
n=19 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
3 Participants
n=19 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
2 Participants
n=19 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
0 Participants
|
1 Participants
n=19 Participants
|
PRIMARY outcome
Timeframe: Day 1-8 per period, along with the 28-35 day post-final dose follow-upPopulation: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An adverse event is considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the study were flagged as TEAEs. The algorithm did not consider any events that started prior to the first dose date. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Outcome measures
| Measure |
Placebo
n=13 Participants
Participants assigned to Cohort 1, Cohort 2, and Cohort 3 received placebo.
|
Placebo (Fed)
n=2 Participants
Participants assigned to Cohort 3 received placebo (fed).
|
PF-07328948 10 mg
n=6 Participants
Participants assigned to Cohort 1 received PF-07328948 10 mg.
|
PF-07328948 30 mg
n=5 Participants
Participants assigned to Cohort 1 received PF-07328948 30 mg.
|
PF-07328948 100 mg
n=5 Participants
Participants assigned to Cohort 1 received PF-07328948 100 mg.
|
PF-07328948 300 mg
n=12 Participants
Participants assigned to Cohort 1 and Cohort 3 received PF-07328948 300 mg.
|
PF-07328948 750 mg
n=7 Participants
Participants assigned to Cohort 2 and Cohort 3 received PF-07328948 750 mg.
|
PF-07328948 750 mg (Fed)
n=5 Participants
Participants assigned to Cohort 3 received PF-07328948 750 mg (fed).
|
PF-07328948 1500 mg
n=6 Participants
Participants assigned to Cohort 3 received PF-07328948 1500 mg.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)
All-causality AEs
|
3 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)
Treatment-related AEs
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)
All-causality SAEs
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs)
Treatment-related SAEs
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1-8 per period, along with the 28-35 day post-final dose follow-upPopulation: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
Pre-defined categorical criteria for laboratory abnormalities included: lymphocytes/Leukocytes \<0.8 x lower limit of normal (LLN) or \>1.2 x upper limit of normal (ULN); Neutrophils \<0.8 x LLN; Neutrophils/Leukocytes \<0.8 x LLN; Eosinophils/Leukocytes \>1.2 x ULN; Monocytes/Leukocytes \>1.2 x ULN; Bilirubin \>1.5 x ULN; Indirect Bilirubin \>1.5 x ULN; Ketones (Scalar) ≥1; URINE Hemoglobin (Scalar) ≥1; URINE Bilirubin (Scalar) ≥1; Leukocyte Esterase (Scalar) ≥1; and Bacteria (/HPF) \>20.
Outcome measures
| Measure |
Placebo
n=13 Participants
Participants assigned to Cohort 1, Cohort 2, and Cohort 3 received placebo.
|
Placebo (Fed)
n=2 Participants
Participants assigned to Cohort 3 received placebo (fed).
|
PF-07328948 10 mg
n=6 Participants
Participants assigned to Cohort 1 received PF-07328948 10 mg.
|
PF-07328948 30 mg
n=5 Participants
Participants assigned to Cohort 1 received PF-07328948 30 mg.
|
PF-07328948 100 mg
n=5 Participants
Participants assigned to Cohort 1 received PF-07328948 100 mg.
|
PF-07328948 300 mg
n=12 Participants
Participants assigned to Cohort 1 and Cohort 3 received PF-07328948 300 mg.
|
PF-07328948 750 mg
n=7 Participants
Participants assigned to Cohort 2 and Cohort 3 received PF-07328948 750 mg.
|
PF-07328948 750 mg (Fed)
n=5 Participants
Participants assigned to Cohort 3 received PF-07328948 750 mg (fed).
|
PF-07328948 1500 mg
n=6 Participants
Participants assigned to Cohort 3 received PF-07328948 1500 mg.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinical Laboratory Abnormalities Meeting Pre-Defined Categorical Criteria Without Regard to Baseline Abnormality
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Day 1-8 per period, along with the 28-35 day post-final dose follow-upPopulation: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
Vital signs categorical criteria: 1) supine systolic blood pressure (SBP) \<90 millimeters of mercury (mmHg); 2) supine diastolic blood pressure (DBP) \<50 mmHg; 3) supine pulse rate \<40 or \>120 beats per minute (bpm); 4) change from baseline (increase or decrease) in supine SBP greater than or equal to (≥) 30 mmHg; 5) change from baseline (increase or decrease) in supine DBP ≥ 20 mmHg.
Outcome measures
| Measure |
Placebo
n=13 Participants
Participants assigned to Cohort 1, Cohort 2, and Cohort 3 received placebo.
|
Placebo (Fed)
n=2 Participants
Participants assigned to Cohort 3 received placebo (fed).
|
PF-07328948 10 mg
n=6 Participants
Participants assigned to Cohort 1 received PF-07328948 10 mg.
|
PF-07328948 30 mg
n=5 Participants
Participants assigned to Cohort 1 received PF-07328948 30 mg.
|
PF-07328948 100 mg
n=5 Participants
Participants assigned to Cohort 1 received PF-07328948 100 mg.
|
PF-07328948 300 mg
n=12 Participants
Participants assigned to Cohort 1 and Cohort 3 received PF-07328948 300 mg.
|
PF-07328948 750 mg
n=7 Participants
Participants assigned to Cohort 2 and Cohort 3 received PF-07328948 750 mg.
|
PF-07328948 750 mg (Fed)
n=5 Participants
Participants assigned to Cohort 3 received PF-07328948 750 mg (fed).
|
PF-07328948 1500 mg
n=6 Participants
Participants assigned to Cohort 3 received PF-07328948 1500 mg.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Vital Signs Abnormalities Meeting Pre-Defined Categorical Criteria
SBP <90 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Abnormalities Meeting Pre-Defined Categorical Criteria
Change from baseline in SBP ≥30 mmHg decrease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Abnormalities Meeting Pre-Defined Categorical Criteria
Change from baseline in SBP ≥30 mmHg increase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Abnormalities Meeting Pre-Defined Categorical Criteria
DBP <50 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Abnormalities Meeting Pre-Defined Categorical Criteria
Change from baseline in DBP ≥20 decrease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Abnormalities Meeting Pre-Defined Categorical Criteria
Change from baseline in DBP ≥20 increase
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Abnormalities Meeting Pre-Defined Categorical Criteria
Pulse rate < 40 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Abnormalities Meeting Pre-Defined Categorical Criteria
Pulse rate > 120 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1-8 per period, along with the 28-35 day post-final dose follow-upPopulation: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
ECG categorical criteria: 1. PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): a) ≥300 millisecond (msec), b) ≥25% increase when baseline is \> 200 msec or ≥50% increase when baseline is less than or equal to (≤) 200 msec. 2\. QRS interval (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): a) ≥140 msec, b) ≥50% increase from baseline. 3\. QTcF interval (QT corrected using the Fridericia formula): a) \>450 msec and ≤480 msec, b) \>480 msec and ≤500 msec, c) \>500 msec, d) \>30 msec and ≤60 msec increase from baseline, e) \>60 msec increase from baseline
Outcome measures
| Measure |
Placebo
n=13 Participants
Participants assigned to Cohort 1, Cohort 2, and Cohort 3 received placebo.
|
Placebo (Fed)
n=2 Participants
Participants assigned to Cohort 3 received placebo (fed).
|
PF-07328948 10 mg
n=6 Participants
Participants assigned to Cohort 1 received PF-07328948 10 mg.
|
PF-07328948 30 mg
n=5 Participants
Participants assigned to Cohort 1 received PF-07328948 30 mg.
|
PF-07328948 100 mg
n=5 Participants
Participants assigned to Cohort 1 received PF-07328948 100 mg.
|
PF-07328948 300 mg
n=12 Participants
Participants assigned to Cohort 1 and Cohort 3 received PF-07328948 300 mg.
|
PF-07328948 750 mg
n=7 Participants
Participants assigned to Cohort 2 and Cohort 3 received PF-07328948 750 mg.
|
PF-07328948 750 mg (Fed)
n=5 Participants
Participants assigned to Cohort 3 received PF-07328948 750 mg (fed).
|
PF-07328948 1500 mg
n=6 Participants
Participants assigned to Cohort 3 received PF-07328948 1500 mg.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Meeting Pre-Defined Categorical Criteria
Change in QTcF interval >30 and ≤60 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Meeting Pre-Defined Categorical Criteria
PR interval ≥300 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Meeting Pre-Defined Categorical Criteria
%Change in PR interval ≥25/50% increase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Meeting Pre-Defined Categorical Criteria
QRS interval ≥140 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Meeting Pre-Defined Categorical Criteria
%Change in QRS interval ≥50% increase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Meeting Pre-Defined Categorical Criteria
QTcF interval >450 and ≤480 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Meeting Pre-Defined Categorical Criteria
QTcF interval >480 and ≤500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Meeting Pre-Defined Categorical Criteria
QTcF interval >500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Meeting Pre-Defined Categorical Criteria
Change in QTcF interval >60 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1-8 per period, along with the 28-35 day post-final dose follow-upPopulation: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
Maximum increase from baseline in ECG Mean Heart Rate was reported.
Outcome measures
| Measure |
Placebo
n=13 Participants
Participants assigned to Cohort 1, Cohort 2, and Cohort 3 received placebo.
|
Placebo (Fed)
n=2 Participants
Participants assigned to Cohort 3 received placebo (fed).
|
PF-07328948 10 mg
n=6 Participants
Participants assigned to Cohort 1 received PF-07328948 10 mg.
|
PF-07328948 30 mg
n=5 Participants
Participants assigned to Cohort 1 received PF-07328948 30 mg.
|
PF-07328948 100 mg
n=5 Participants
Participants assigned to Cohort 1 received PF-07328948 100 mg.
|
PF-07328948 300 mg
n=12 Participants
Participants assigned to Cohort 1 and Cohort 3 received PF-07328948 300 mg.
|
PF-07328948 750 mg
n=7 Participants
Participants assigned to Cohort 2 and Cohort 3 received PF-07328948 750 mg.
|
PF-07328948 750 mg (Fed)
n=5 Participants
Participants assigned to Cohort 3 received PF-07328948 750 mg (fed).
|
PF-07328948 1500 mg
n=6 Participants
Participants assigned to Cohort 3 received PF-07328948 1500 mg.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Electrocardiogram (ECG) Parameters (ECG Mean Heart Rate)
|
9.52 bpm
Standard Deviation 5.179
|
12.45 bpm
Standard Deviation 2.616
|
9.75 bpm
Standard Deviation 2.752
|
12.88 bpm
Standard Deviation 3.321
|
8.36 bpm
Standard Deviation 4.821
|
16.32 bpm
Standard Deviation 14.132
|
15.53 bpm
Standard Deviation 3.892
|
16.32 bpm
Standard Deviation 4.437
|
13.42 bpm
Standard Deviation 3.845
|
PRIMARY outcome
Timeframe: Day 1-8 per period, along with the 28-35 day post-final dose follow-upPopulation: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
Maximum increase from baseline in PR Interval, QRS Duration, and QTcF Interval was reported.
Outcome measures
| Measure |
Placebo
n=13 Participants
Participants assigned to Cohort 1, Cohort 2, and Cohort 3 received placebo.
|
Placebo (Fed)
n=2 Participants
Participants assigned to Cohort 3 received placebo (fed).
|
PF-07328948 10 mg
n=6 Participants
Participants assigned to Cohort 1 received PF-07328948 10 mg.
|
PF-07328948 30 mg
n=5 Participants
Participants assigned to Cohort 1 received PF-07328948 30 mg.
|
PF-07328948 100 mg
n=5 Participants
Participants assigned to Cohort 1 received PF-07328948 100 mg.
|
PF-07328948 300 mg
n=12 Participants
Participants assigned to Cohort 1 and Cohort 3 received PF-07328948 300 mg.
|
PF-07328948 750 mg
n=7 Participants
Participants assigned to Cohort 2 and Cohort 3 received PF-07328948 750 mg.
|
PF-07328948 750 mg (Fed)
n=5 Participants
Participants assigned to Cohort 3 received PF-07328948 750 mg (fed).
|
PF-07328948 1500 mg
n=6 Participants
Participants assigned to Cohort 3 received PF-07328948 1500 mg.
|
|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in ECG Parameters (PR Interval, QRS Duration, and QTcF Interval)
Maximum increase from baseline in PR Interval (msec)
|
5.15 msec
Standard Deviation 5.536
|
5.10 msec
Standard Deviation 1.414
|
2.30 msec
Standard Deviation 4.260
|
2.12 msec
Standard Deviation 2.139
|
0.80 msec
Standard Deviation 4.540
|
3.93 msec
Standard Deviation 3.215
|
6.86 msec
Standard Deviation 8.703
|
10.00 msec
Standard Deviation 5.477
|
5.73 msec
Standard Deviation 1.952
|
|
Change From Baseline in ECG Parameters (PR Interval, QRS Duration, and QTcF Interval)
Maximum increase from baseline in QTcF Interval (msec)
|
6.95 msec
Standard Deviation 5.949
|
7.40 msec
Standard Deviation 3.960
|
3.10 msec
Standard Deviation 4.900
|
3.40 msec
Standard Deviation 2.879
|
1.78 msec
Standard Deviation 6.634
|
2.84 msec
Standard Deviation 4.702
|
6.90 msec
Standard Deviation 11.844
|
1.50 msec
Standard Deviation 5.236
|
8.47 msec
Standard Deviation 8.281
|
|
Change From Baseline in ECG Parameters (PR Interval, QRS Duration, and QTcF Interval)
Maximum increase from baseline in QRS Duration (msec)
|
3.54 msec
Standard Deviation 3.227
|
10.60 msec
Standard Deviation 3.111
|
1.73 msec
Standard Deviation 2.534
|
2.44 msec
Standard Deviation 2.014
|
0.14 msec
Standard Deviation 0.969
|
4.11 msec
Standard Deviation 2.858
|
0.91 msec
Standard Deviation 3.065
|
6.20 msec
Standard Deviation 3.251
|
4.40 msec
Standard Deviation 5.303
|
SECONDARY outcome
Timeframe: Pre-dose (0 hours) and 0.5 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing of each Period (Periods 1-4)Population: All participants randomly assigned to study intervention and who received at least 1 dose of study intervention and had at least 1 of the PK parameters of interest calculated.
Maximum observed plasma PF-07328948 concentration. Observed directly from data.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants assigned to Cohort 1, Cohort 2, and Cohort 3 received placebo.
|
Placebo (Fed)
n=5 Participants
Participants assigned to Cohort 3 received placebo (fed).
|
PF-07328948 10 mg
n=5 Participants
Participants assigned to Cohort 1 received PF-07328948 10 mg.
|
PF-07328948 30 mg
n=12 Participants
Participants assigned to Cohort 1 received PF-07328948 30 mg.
|
PF-07328948 100 mg
n=7 Participants
Participants assigned to Cohort 1 received PF-07328948 100 mg.
|
PF-07328948 300 mg
n=5 Participants
Participants assigned to Cohort 1 and Cohort 3 received PF-07328948 300 mg.
|
PF-07328948 750 mg
n=6 Participants
Participants assigned to Cohort 2 and Cohort 3 received PF-07328948 750 mg.
|
PF-07328948 750 mg (Fed)
Participants assigned to Cohort 3 received PF-07328948 750 mg (fed).
|
PF-07328948 1500 mg
Participants assigned to Cohort 3 received PF-07328948 1500 mg.
|
|---|---|---|---|---|---|---|---|---|---|
|
Maximum Concentration Observed in Plasma (Cmax)
|
294.7 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 111
|
1549 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 11
|
7049 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 18
|
19100 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 25
|
40220 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 33
|
37440 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 13
|
61030 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 44
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (0 hours) and 0.5 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing of each Period (Periods 1-4)Population: All participants randomly assigned to study intervention and who received at least 1 dose of study intervention and had at least 1 of the PK parameters of interest calculated.
Observed directly from data as time of first occurrence.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants assigned to Cohort 1, Cohort 2, and Cohort 3 received placebo.
|
Placebo (Fed)
n=5 Participants
Participants assigned to Cohort 3 received placebo (fed).
|
PF-07328948 10 mg
n=5 Participants
Participants assigned to Cohort 1 received PF-07328948 10 mg.
|
PF-07328948 30 mg
n=12 Participants
Participants assigned to Cohort 1 received PF-07328948 30 mg.
|
PF-07328948 100 mg
n=7 Participants
Participants assigned to Cohort 1 received PF-07328948 100 mg.
|
PF-07328948 300 mg
n=5 Participants
Participants assigned to Cohort 1 and Cohort 3 received PF-07328948 300 mg.
|
PF-07328948 750 mg
n=6 Participants
Participants assigned to Cohort 2 and Cohort 3 received PF-07328948 750 mg.
|
PF-07328948 750 mg (Fed)
Participants assigned to Cohort 3 received PF-07328948 750 mg (fed).
|
PF-07328948 1500 mg
Participants assigned to Cohort 3 received PF-07328948 1500 mg.
|
|---|---|---|---|---|---|---|---|---|---|
|
Time to Achieve Cmax (Tmax)
|
1.10 hours (hr)
Interval 1.0 to 3.0
|
3.00 hours (hr)
Interval 1.0 to 4.0
|
2.00 hours (hr)
Interval 1.5 to 3.0
|
3.00 hours (hr)
Interval 1.5 to 4.0
|
3.02 hours (hr)
Interval 3.0 to 4.02
|
4.00 hours (hr)
Interval 2.0 to 4.03
|
3.04 hours (hr)
Interval 2.0 to 8.03
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (0 hours) and 0.5 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing of each Period (Periods 1-4)Population: All participants randomly assigned to study intervention and who received at least 1 dose of study intervention and had at least 1 of the PK parameters of interest calculated. Number of participants analyzed = participants who were evaluable for this OM and contributed to the summary statistics of this OM.
Area under the plasma concentration time-curve from zero to the last measured concentration. It was determined by using linear/Log trapezoidal method.
Outcome measures
| Measure |
Placebo
n=3 Participants
Participants assigned to Cohort 1, Cohort 2, and Cohort 3 received placebo.
|
Placebo (Fed)
n=5 Participants
Participants assigned to Cohort 3 received placebo (fed).
|
PF-07328948 10 mg
n=5 Participants
Participants assigned to Cohort 1 received PF-07328948 10 mg.
|
PF-07328948 30 mg
n=12 Participants
Participants assigned to Cohort 1 received PF-07328948 30 mg.
|
PF-07328948 100 mg
n=7 Participants
Participants assigned to Cohort 1 received PF-07328948 100 mg.
|
PF-07328948 300 mg
n=5 Participants
Participants assigned to Cohort 1 and Cohort 3 received PF-07328948 300 mg.
|
PF-07328948 750 mg
n=6 Participants
Participants assigned to Cohort 2 and Cohort 3 received PF-07328948 750 mg.
|
PF-07328948 750 mg (Fed)
Participants assigned to Cohort 3 received PF-07328948 750 mg (fed).
|
PF-07328948 1500 mg
Participants assigned to Cohort 3 received PF-07328948 1500 mg.
|
|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Measured Concentration (AUClast)
|
0.0000 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation NA
The CV is NA (not reportable) for the PF-07328948 10 mg as all 3 individuals had values of 0 with mean of 0 and CV is undefinable.
|
4396 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 11
|
35030 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 23
|
110200 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 30
|
363600 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 24
|
409300 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 26
|
742700 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 24
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (0 hours) and 0.5 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing of each Period (Periods 1-4)Population: All participants randomly assigned to study intervention and who received at least 1 dose of study intervention and had at least 1 of the PK parameters of interest calculated. Number of participants analyzed = participants who were evaluable for this OM and contributed to the summary statistics of this OM.
Area under the plasma concentration-time curve from time 0 extrapolated to infinite time. AUCinf = AUClast + (Clast\*/kel), where Clast\* is the predicted plasma concentration at the last quantifiable timepoint estimated from the log-linear regression analysis, and Kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve, AUClast = Area under the plasma concentration time-curve from zero to the last measured concentration.
Outcome measures
| Measure |
Placebo
Participants assigned to Cohort 1, Cohort 2, and Cohort 3 received placebo.
|
Placebo (Fed)
Participants assigned to Cohort 3 received placebo (fed).
|
PF-07328948 10 mg
n=4 Participants
Participants assigned to Cohort 1 received PF-07328948 10 mg.
|
PF-07328948 30 mg
n=11 Participants
Participants assigned to Cohort 1 received PF-07328948 30 mg.
|
PF-07328948 100 mg
n=7 Participants
Participants assigned to Cohort 1 received PF-07328948 100 mg.
|
PF-07328948 300 mg
n=5 Participants
Participants assigned to Cohort 1 and Cohort 3 received PF-07328948 300 mg.
|
PF-07328948 750 mg
n=4 Participants
Participants assigned to Cohort 2 and Cohort 3 received PF-07328948 750 mg.
|
PF-07328948 750 mg (Fed)
Participants assigned to Cohort 3 received PF-07328948 750 mg (fed).
|
PF-07328948 1500 mg
Participants assigned to Cohort 3 received PF-07328948 1500 mg.
|
|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
|
—
|
—
|
39050 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 19
|
114300 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 32
|
378000 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 26
|
427600 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 29
|
774600 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 28
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (0 hours) and 0.5 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 8 hours and 12 hours post Day 1 dosing of each Period (Periods 1-4)Population: All participants randomly assigned to study intervention and who received at least 1 dose of study intervention and had at least 1 of the PK parameters of interest calculated. Number of participants analyzed = participants who were evaluable for this OM and contributed to the summary statistics of this OM.
Terminal elimination half-life. t1/2 = Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. Only those data points judged to describe the terminal log linear decline will be used in the regression.
Outcome measures
| Measure |
Placebo
Participants assigned to Cohort 1, Cohort 2, and Cohort 3 received placebo.
|
Placebo (Fed)
Participants assigned to Cohort 3 received placebo (fed).
|
PF-07328948 10 mg
n=4 Participants
Participants assigned to Cohort 1 received PF-07328948 10 mg.
|
PF-07328948 30 mg
n=11 Participants
Participants assigned to Cohort 1 received PF-07328948 30 mg.
|
PF-07328948 100 mg
n=7 Participants
Participants assigned to Cohort 1 received PF-07328948 100 mg.
|
PF-07328948 300 mg
n=5 Participants
Participants assigned to Cohort 1 and Cohort 3 received PF-07328948 300 mg.
|
PF-07328948 750 mg
n=4 Participants
Participants assigned to Cohort 2 and Cohort 3 received PF-07328948 750 mg.
|
PF-07328948 750 mg (Fed)
Participants assigned to Cohort 3 received PF-07328948 750 mg (fed).
|
PF-07328948 1500 mg
Participants assigned to Cohort 3 received PF-07328948 1500 mg.
|
|---|---|---|---|---|---|---|---|---|---|
|
Terminal Half-Life (t1/2) of PF-07328948
|
—
|
—
|
11.58 hours (hr)
Standard Deviation 4.2565
|
9.941 hours (hr)
Standard Deviation 2.4980
|
16.13 hours (hr)
Standard Deviation 6.5277
|
16.90 hours (hr)
Standard Deviation 5.1749
|
15.90 hours (hr)
Standard Deviation 5.5106
|
—
|
—
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo (Fed)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
PF-07328948 10 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
PF-07328948 30 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
PF-07328948 100 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
PF-07328948 300 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
PF-07328948 750 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
PF-07328948 750 mg (Fed)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
PF-07328948 1500 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=13 participants at risk
Participants assigned to Cohort 1, Cohort 2, and Cohort 3 received placebo.
|
Placebo (Fed)
n=2 participants at risk
Participants assigned to Cohort 3 received placebo (fed).
|
PF-07328948 10 mg
n=6 participants at risk
Participants assigned to Cohort 1 received PF-07328948 10 mg.
|
PF-07328948 30 mg
n=5 participants at risk
Participants assigned to Cohort 1 received PF-07328948 30 mg.
|
PF-07328948 100 mg
n=5 participants at risk
Participants assigned to Cohort 1 received PF-07328948 100 mg.
|
PF-07328948 300 mg
n=12 participants at risk
Participants assigned to Cohort 1 and Cohort 3 received PF-07328948 300 mg.
|
PF-07328948 750 mg
n=7 participants at risk
Participants assigned to Cohort 2 and Cohort 3 received PF-07328948 750 mg.
|
PF-07328948 750 mg (Fed)
n=5 participants at risk
Participants assigned to Cohort 3 received PF-07328948 750 mg (fed).
|
PF-07328948 1500 mg
n=6 participants at risk
Participants assigned to Cohort 3 received PF-07328948 1500 mg.
|
|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Seizure
|
7.7%
1/13 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
Other adverse events
| Measure |
Placebo
n=13 participants at risk
Participants assigned to Cohort 1, Cohort 2, and Cohort 3 received placebo.
|
Placebo (Fed)
n=2 participants at risk
Participants assigned to Cohort 3 received placebo (fed).
|
PF-07328948 10 mg
n=6 participants at risk
Participants assigned to Cohort 1 received PF-07328948 10 mg.
|
PF-07328948 30 mg
n=5 participants at risk
Participants assigned to Cohort 1 received PF-07328948 30 mg.
|
PF-07328948 100 mg
n=5 participants at risk
Participants assigned to Cohort 1 received PF-07328948 100 mg.
|
PF-07328948 300 mg
n=12 participants at risk
Participants assigned to Cohort 1 and Cohort 3 received PF-07328948 300 mg.
|
PF-07328948 750 mg
n=7 participants at risk
Participants assigned to Cohort 2 and Cohort 3 received PF-07328948 750 mg.
|
PF-07328948 750 mg (Fed)
n=5 participants at risk
Participants assigned to Cohort 3 received PF-07328948 750 mg (fed).
|
PF-07328948 1500 mg
n=6 participants at risk
Participants assigned to Cohort 3 received PF-07328948 1500 mg.
|
|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/13 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
14.3%
1/7 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Application site dermatitis
|
15.4%
2/13 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Chest discomfort
|
0.00%
0/13 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
14.3%
1/7 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Fatigue
|
0.00%
0/13 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/13 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/13 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Acute sinusitis
|
7.7%
1/13 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
COVID-19
|
0.00%
0/13 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/13 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
14.3%
1/7 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/13 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/13 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Headache
|
7.7%
1/13 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
2/12 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Neurological symptom
|
7.7%
1/13 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/13 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/13 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/13 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/13 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/13 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/13 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/13 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/13 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
14.3%
1/7 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/13 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
1/2 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/13 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
14.3%
1/7 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/13 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
14.3%
1/7 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Vision blurred
|
0.00%
0/13 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
14.3%
1/7 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/13 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
20.0%
1/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
7.7%
1/13 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/12 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Blood pressure increased
|
0.00%
0/13 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Investigations
Heart rate increased
|
0.00%
0/13 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/2 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
8.3%
1/12 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/7 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/5 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Day 1-8 per period, along with the 28-35 day post-final dose follow-up
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place