Trial Outcomes & Findings for A Study to Learn How Different Amounts of the Study Medicine Called PF-06954522 Are Tolerated and Act in the Body in Healthy Adults (NCT NCT06003777)

NCT ID: NCT06003777

Last Updated: 2025-06-24

Results Overview

An adverse event (AEs) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that start on or after the first dose of study intervention, but before the end of the study were flagged as TEAEs. Serious AE (SAE) was defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect. AEs included SAEs and non-SAEs.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 26 participants
• Primary outcome timeframe: From Day 1 up to 35 days after last of study drug (maximum up to approximately 88 days)
• Results posted on: 2025-06-24

Participant Flow

A total of 26 participants (initially randomized participants and replacement participants) were enrolled in this study. All participants received at least 1 dose of study intervention and were assigned in the study into 3 cohorts. As planned, there were "replacement" participants in the study who may or may not be required to complete all periods of the cohort in which they were participating at the discretion of the principal investigator and sponsor.

In this study, dose have been reported from dose levels A to F, wherein Dose A is the lowest dose and Dose F is the highest dose received by study participants.

Participant milestones

Measure	Cohort 1: Sequence 1 Participants received PF-06954522 matching placebo on Day 1 Period 1 then PF-06954522 dose level D in Period 2 then PF-06954522 dose level E in Period 3, PF-06954522 dose level D fed state high fat in Period 4 followed by PF-06954522 dose level F in Period 5. There was a washout period of 7 days in between each period.	Cohort 1: Sequence 2 Participants received PF-06954522 dose level C on Day 1 Period 1 then PF-06954522 matching placebo in Period 2 then PF-06954522 dose level E in Period 3, PF-06954522 matching placebo in Period 4 in fed state (high-fat meal) followed by PF-06954522 dose level F in Period 5. There was a washout period of 7 days in between each period.	Cohort 1: Sequence 3 Participants received PF-06954522 dose level C on Day 1 Period 1 then PF-06954522 dose level D in Period 2 then PF-06954522 matching placebo in Period 3, PF-06954522 dose level D fed state high fat in Period 4 followed by PF-06954522 dose level F in Period 5. There was a washout period of 7 days in between each period.	Cohort 1: Sequence 4 Participants received PF-06954522 dose level C on Day 1 Period 1 then PF-06954522 dose level D in Period 2 then PF-06954522 dose level E in Period 3, PF-06954522 dose level D in Period 4 in fed state (high-fat meal) followed by PF-06954522 matching placebo in Period 5. There was a washout period of 7 days in between each period.	Cohort 1: Sequence 5 Participants received PF-06954522 dose level C on Day 1 Period 1 then PF-06954522 dose level D in Period 2 then PF-06954522 dose level E in Period 3, PF-06954522 dose level D fed state high fat in Period 4 followed by PF-06954522 dose level F in Period 5. There was a washout period of 7 days in between each period.	Cohort 2: Sequence 1 Participants received PF-06954522 matching placebo on Day 1 Period 1 then PF-06954522 dose level A fed state standard meal in Period 2 then PF-06954522 dose level B fed state high fat meal in Period 3 followed by PF-06954522 dose level F in Period 4. There was a washout period of 7 days in between each period.	Cohort 2: Sequence 2 Participants received PF-06954522 dose level B on Day 1 Period 1 then PF-06954522 matching placebo in Period 2 in fed state (standard meal) then PF-06954522 matching placebo in Period 3 in fed state (high-fat meal) followed by PF-06954522 dose level F in Period 4. There was a washout period of 7 days in between each period.	Cohort 2: Sequence 3 Participants received PF-06954522 dose level B on Day 1 Period 1 then PF-06954522 dose level A fed state standard meal in Period 2 then PF-06954522 dose level B fed state high fat in Period 3 followed by PF-06954522 dose level F in Period 4. There was a washout period of 7 days in between each period.	Cohort 2: Sequence 4 Participants received PF-06954522 dose level B on Day 1 Period 1 then PF-06954522 dose level A fed state standard meal in Period 2 then PF-06954522 dose level B fed state high fat in Period 3 followed by PF-06954522 matching placebo in Period 4. There was a washout period of 7 days in between each period.	Cohort 3: Sequence 1 Japanese participants received PF-06954522 matching placebo on Day 1 Period 1 then PF-06954522 dose level E in Period 2 followed by PF-06954522 matching placebo in Period 3 in fed state (high-fat meal). There was a washout period of 7 days in between each period.	Cohort 3: Sequence 2 Japanese participants received PF-06954522 dose level D on Day 1 Period 1 then PF-06954522 matching placebo in Period 2 followed by PF-06954522 dose level D fed state high fat in Period 3. There was a washout period of 7 days in between each period.	Cohort 3: Sequence 3 Japanese participants received PF-06954522 dose level D on Day 1 Period 1 then PF-06954522 dose level E in Period 2 followed by PF-06954522 dose level D fed state high fat in Period 3. There was a washout period of 7 days in between each period.
Period 1 STARTED	2	1	2	2	2	2	2	2	2	2	2	2
Period 1 COMPLETED	2	1	1	2	1	2	2	2	2	2	2	2
Period 1 NOT COMPLETED	0	0	1	0	1	0	0	0	0	0	0	0
Period 2 STARTED	2	2	2	2	2	2	2	2	2	2	2	1
Period 2 COMPLETED	2	2	2	2	2	2	2	2	1	2	2	1
Period 2 NOT COMPLETED	0	0	0	0	0	0	0	0	1	0	0	0
Period 3 STARTED	2	2	2	2	2	1	2	2	1	2	2	2
Period 3 COMPLETED	2	2	2	2	2	1	1	2	1	2	2	2
Period 3 NOT COMPLETED	0	0	0	0	0	0	1	0	0	0	0	0
Period 4 STARTED	2	2	2	2	2	2	1	2	1	0	0	0
Period 4 COMPLETED	2	1	1	2	2	2	1	2	1	0	0	0
Period 4 NOT COMPLETED	0	1	1	0	0	0	0	0	0	0	0	0
Period 5 STARTED	2	1	1	2	2	0	0	0	0	0	0	0
Period 5 COMPLETED	2	1	1	2	2	0	0	0	0	0	0	0
Period 5 NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Measure	Cohort 1: Sequence 1 Participants received PF-06954522 matching placebo on Day 1 Period 1 then PF-06954522 dose level D in Period 2 then PF-06954522 dose level E in Period 3, PF-06954522 dose level D fed state high fat in Period 4 followed by PF-06954522 dose level F in Period 5. There was a washout period of 7 days in between each period.	Cohort 1: Sequence 2 Participants received PF-06954522 dose level C on Day 1 Period 1 then PF-06954522 matching placebo in Period 2 then PF-06954522 dose level E in Period 3, PF-06954522 matching placebo in Period 4 in fed state (high-fat meal) followed by PF-06954522 dose level F in Period 5. There was a washout period of 7 days in between each period.	Cohort 1: Sequence 3 Participants received PF-06954522 dose level C on Day 1 Period 1 then PF-06954522 dose level D in Period 2 then PF-06954522 matching placebo in Period 3, PF-06954522 dose level D fed state high fat in Period 4 followed by PF-06954522 dose level F in Period 5. There was a washout period of 7 days in between each period.	Cohort 1: Sequence 4 Participants received PF-06954522 dose level C on Day 1 Period 1 then PF-06954522 dose level D in Period 2 then PF-06954522 dose level E in Period 3, PF-06954522 dose level D in Period 4 in fed state (high-fat meal) followed by PF-06954522 matching placebo in Period 5. There was a washout period of 7 days in between each period.	Cohort 1: Sequence 5 Participants received PF-06954522 dose level C on Day 1 Period 1 then PF-06954522 dose level D in Period 2 then PF-06954522 dose level E in Period 3, PF-06954522 dose level D fed state high fat in Period 4 followed by PF-06954522 dose level F in Period 5. There was a washout period of 7 days in between each period.	Cohort 2: Sequence 1 Participants received PF-06954522 matching placebo on Day 1 Period 1 then PF-06954522 dose level A fed state standard meal in Period 2 then PF-06954522 dose level B fed state high fat meal in Period 3 followed by PF-06954522 dose level F in Period 4. There was a washout period of 7 days in between each period.	Cohort 2: Sequence 2 Participants received PF-06954522 dose level B on Day 1 Period 1 then PF-06954522 matching placebo in Period 2 in fed state (standard meal) then PF-06954522 matching placebo in Period 3 in fed state (high-fat meal) followed by PF-06954522 dose level F in Period 4. There was a washout period of 7 days in between each period.	Cohort 2: Sequence 3 Participants received PF-06954522 dose level B on Day 1 Period 1 then PF-06954522 dose level A fed state standard meal in Period 2 then PF-06954522 dose level B fed state high fat in Period 3 followed by PF-06954522 dose level F in Period 4. There was a washout period of 7 days in between each period.	Cohort 2: Sequence 4 Participants received PF-06954522 dose level B on Day 1 Period 1 then PF-06954522 dose level A fed state standard meal in Period 2 then PF-06954522 dose level B fed state high fat in Period 3 followed by PF-06954522 matching placebo in Period 4. There was a washout period of 7 days in between each period.	Cohort 3: Sequence 1 Japanese participants received PF-06954522 matching placebo on Day 1 Period 1 then PF-06954522 dose level E in Period 2 followed by PF-06954522 matching placebo in Period 3 in fed state (high-fat meal). There was a washout period of 7 days in between each period.	Cohort 3: Sequence 2 Japanese participants received PF-06954522 dose level D on Day 1 Period 1 then PF-06954522 matching placebo in Period 2 followed by PF-06954522 dose level D fed state high fat in Period 3. There was a washout period of 7 days in between each period.	Cohort 3: Sequence 3 Japanese participants received PF-06954522 dose level D on Day 1 Period 1 then PF-06954522 dose level E in Period 2 followed by PF-06954522 dose level D fed state high fat in Period 3. There was a washout period of 7 days in between each period.
Period 1 Adverse Event	0	0	1	0	0	0	0	0	0	0	0	0
Period 1 Withdrawal by Subject	0	0	0	0	1	0	0	0	0	0	0	0
Period 2 Withdrawal by Subject	0	0	0	0	0	0	0	0	1	0	0	0
Period 3 Adverse Event	0	0	0	0	0	0	1	0	0	0	0	0
Period 4 No longer met eligibility criteria	0	0	1	0	0	0	0	0	0	0	0	0
Period 4 Withdrawal by Subject	0	1	0	0	0	0	0	0	0	0	0	0

Baseline Characteristics

A Study to Learn How Different Amounts of the Study Medicine Called PF-06954522 Are Tolerated and Act in the Body in Healthy Adults

Baseline characteristics by cohort

Measure	Cohort 1 n=12 Participants Participants received up to 5 dose levels of PF-06954522 and matching placebo.	Cohort 2 n=8 Participants Participants received up to 4 dose levels of PF-06954522 and matching placebo.	Cohort 3 n=6 Participants Participants received up to 3 dose levels of PF-06954522 and matching placebo.	Total n=26 Participants Total of all reporting groups
Age, Continuous	43.6 Years STANDARD_DEVIATION 9.84 • n=5 Participants	42.1 Years STANDARD_DEVIATION 11.44 • n=7 Participants	42.5 Years STANDARD_DEVIATION 12.28 • n=5 Participants	42.9 Years STANDARD_DEVIATION 10.48 • n=4 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	8 Participants n=7 Participants	6 Participants n=5 Participants	23 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	10 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	16 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants	7 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	7 Participants n=4 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	10 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: From Day 1 up to 35 days after last of study drug (maximum up to approximately 88 days)

Population: Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention.

An adverse event (AEs) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that start on or after the first dose of study intervention, but before the end of the study were flagged as TEAEs. Serious AE (SAE) was defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect. AEs included SAEs and non-SAEs.

Outcome measures

Measure	Cohort 1: PF-06954522 Dose Level C n=7 Participants Participants received PF-06954522 dose level C in fasted state.	Cohort 1: PF-06954522 Dose Level D n=8 Participants Participants received PF-06954522 dose level D in fasted state.	Cohort 1: PF-06954522 Dose Level D (Fed State High Fat Meal) n=8 Participants Participants received PF-06954522 dose level D in fed state with a high fat meal.	Cohort 1: PF-06954522 Dose Level E n=8 Participants Participants received PF-06954522 dose level E in fasted state.	Cohort 1: PF-06954522 Dose Level F n=6 Participants Participants received PF-06954522 dose level F in fasted state.	Cohort 1 and 2: Placebo (Fasted State) n=11 Participants Participants received PF-06954522 matching placebo in fasted state.	Cohort 1 and 2: Placebo (Fed State) n=4 Participants Participants received PF-06954522 matching placebo in fed state with high fat meal.
Cohort 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs)	5 Participants	8 Participants	6 Participants	8 Participants	6 Participants	3 Participants	1 Participants

PRIMARY outcome

Timeframe: From Day 1 up to 35 days after last of study drug (maximum up to approximately 76 days)

Population: Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention.

An AEs was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that start on or after the first dose of study intervention, but before the end of the study were flagged as TEAEs. SAE was defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect. AEs included SAEs and non-SAEs.

Outcome measures

Measure	Cohort 1: PF-06954522 Dose Level C n=11 Participants Participants received PF-06954522 dose level C in fasted state.	Cohort 1: PF-06954522 Dose Level D n=2 Participants Participants received PF-06954522 dose level D in fasted state.	Cohort 1: PF-06954522 Dose Level D (Fed State High Fat Meal) n=4 Participants Participants received PF-06954522 dose level D in fed state with a high fat meal.	Cohort 1: PF-06954522 Dose Level E n=6 Participants Participants received PF-06954522 dose level E in fasted state.	Cohort 1: PF-06954522 Dose Level F n=6 Participants Participants received PF-06954522 dose level F in fasted state.	Cohort 1 and 2: Placebo (Fasted State) n=4 Participants Participants received PF-06954522 matching placebo in fasted state.	Cohort 1 and 2: Placebo (Fed State) n=5 Participants Participants received PF-06954522 matching placebo in fed state with high fat meal.
Cohort 2: Number of Participants With TEAEs	3 Participants	0 Participants	1 Participants	2 Participants	2 Participants	0 Participants	5 Participants

PRIMARY outcome

Timeframe: From Day 1 up to 35 days after last of study drug (maximum up to approximately 64 days)

Population: Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention.

An AEs was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that start on or after the first dose of study intervention, but before the end of the study were flagged as TEAEs. SAE was defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria: death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly or birth defect. AEs included SAEs and non-SAEs.

Outcome measures

Measure	Cohort 1: PF-06954522 Dose Level C n=4 Participants Participants received PF-06954522 dose level C in fasted state.	Cohort 1: PF-06954522 Dose Level D n=2 Participants Participants received PF-06954522 dose level D in fasted state.	Cohort 1: PF-06954522 Dose Level D (Fed State High Fat Meal) n=4 Participants Participants received PF-06954522 dose level D in fed state with a high fat meal.	Cohort 1: PF-06954522 Dose Level E n=4 Participants Participants received PF-06954522 dose level E in fasted state.	Cohort 1: PF-06954522 Dose Level F n=3 Participants Participants received PF-06954522 dose level F in fasted state.	Cohort 1 and 2: Placebo (Fasted State) Participants received PF-06954522 matching placebo in fasted state.	Cohort 1 and 2: Placebo (Fed State) Participants received PF-06954522 matching placebo in fed state with high fat meal.
Cohort 3: Number of Participants With TEAEs	3 Participants	2 Participants	4 Participants	4 Participants	3 Participants	—	—

PRIMARY outcome

Timeframe: From Day 1 up to 35 days after last of study drug (maximum up to approximately 88 days)

Population: Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention.

Planned hematology laboratory tests included: hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.

Outcome measures

Measure	Cohort 1: PF-06954522 Dose Level C n=7 Participants Participants received PF-06954522 dose level C in fasted state.	Cohort 1: PF-06954522 Dose Level D n=8 Participants Participants received PF-06954522 dose level D in fasted state.	Cohort 1: PF-06954522 Dose Level D (Fed State High Fat Meal) n=8 Participants Participants received PF-06954522 dose level D in fed state with a high fat meal.	Cohort 1: PF-06954522 Dose Level E n=8 Participants Participants received PF-06954522 dose level E in fasted state.	Cohort 1: PF-06954522 Dose Level F n=6 Participants Participants received PF-06954522 dose level F in fasted state.	Cohort 1 and 2: Placebo (Fasted State) n=11 Participants Participants received PF-06954522 matching placebo in fasted state.	Cohort 1 and 2: Placebo (Fed State) n=4 Participants Participants received PF-06954522 matching placebo in fed state with high fat meal.
Cohort 1: Number of Participants With Hematology Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	0 Participants	0 Participants	3 Participants	2 Participants	1 Participants	3 Participants	2 Participants

PRIMARY outcome

Timeframe: From Day 1 up to 35 days after last of study drug (maximum up to approximately 76 days)

Population: Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention.

Planned hematology laboratory tests included: hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.

Outcome measures

Measure	Cohort 1: PF-06954522 Dose Level C n=11 Participants Participants received PF-06954522 dose level C in fasted state.	Cohort 1: PF-06954522 Dose Level D n=2 Participants Participants received PF-06954522 dose level D in fasted state.	Cohort 1: PF-06954522 Dose Level D (Fed State High Fat Meal) n=4 Participants Participants received PF-06954522 dose level D in fed state with a high fat meal.	Cohort 1: PF-06954522 Dose Level E n=6 Participants Participants received PF-06954522 dose level E in fasted state.	Cohort 1: PF-06954522 Dose Level F n=6 Participants Participants received PF-06954522 dose level F in fasted state.	Cohort 1 and 2: Placebo (Fasted State) n=4 Participants Participants received PF-06954522 matching placebo in fasted state.	Cohort 1 and 2: Placebo (Fed State) n=5 Participants Participants received PF-06954522 matching placebo in fed state with high fat meal.
Cohort 2: Number of Participants With Hematology Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	3 Participants	1 Participants	2 Participants	3 Participants	2 Participants	1 Participants	4 Participants

PRIMARY outcome

Timeframe: From Day 1 up to 35 days after last of study drug (maximum up to approximately 64 days)

Population: Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention.

Planned hematology laboratory tests included: hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.

Outcome measures

Measure	Cohort 1: PF-06954522 Dose Level C n=4 Participants Participants received PF-06954522 dose level C in fasted state.	Cohort 1: PF-06954522 Dose Level D n=2 Participants Participants received PF-06954522 dose level D in fasted state.	Cohort 1: PF-06954522 Dose Level D (Fed State High Fat Meal) n=4 Participants Participants received PF-06954522 dose level D in fed state with a high fat meal.	Cohort 1: PF-06954522 Dose Level E n=4 Participants Participants received PF-06954522 dose level E in fasted state.	Cohort 1: PF-06954522 Dose Level F n=3 Participants Participants received PF-06954522 dose level F in fasted state.	Cohort 1 and 2: Placebo (Fasted State) Participants received PF-06954522 matching placebo in fasted state.	Cohort 1 and 2: Placebo (Fed State) Participants received PF-06954522 matching placebo in fed state with high fat meal.
Cohort 3: Number of Participants With Hematology Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—

PRIMARY outcome

Timeframe: From Day 1 up to 35 days after last of study drug (maximum up to approximately 88 days)

Population: Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention.

Planned chemistry laboratory tests included: blood urea nitrogen, creatinine, cystatin C, estimated glomerular filtration rate, glucose (fasting), calcium, sodium, potassium. chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, direct and indirect bilirubin, gamma-glutamyl transferase, alkaline phosphatase, creatine kinase, uric acid, albumin and total protein. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.

Outcome measures

Measure	Cohort 1: PF-06954522 Dose Level C n=7 Participants Participants received PF-06954522 dose level C in fasted state.	Cohort 1: PF-06954522 Dose Level D n=8 Participants Participants received PF-06954522 dose level D in fasted state.	Cohort 1: PF-06954522 Dose Level D (Fed State High Fat Meal) n=8 Participants Participants received PF-06954522 dose level D in fed state with a high fat meal.	Cohort 1: PF-06954522 Dose Level E n=8 Participants Participants received PF-06954522 dose level E in fasted state.	Cohort 1: PF-06954522 Dose Level F n=6 Participants Participants received PF-06954522 dose level F in fasted state.	Cohort 1 and 2: Placebo (Fasted State) n=11 Participants Participants received PF-06954522 matching placebo in fasted state.	Cohort 1 and 2: Placebo (Fed State) n=4 Participants Participants received PF-06954522 matching placebo in fed state with high fat meal.
Cohort 1: Number of Participants With Clinical Chemistry Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	3 Participants	0 Participants

PRIMARY outcome

Timeframe: From Day 1 up to 35 days after last of study drug (maximum up to approximately 76 days)

Population: Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention.

Planned chemistry laboratory tests included: blood urea nitrogen, creatinine, cystatin C, estimated glomerular filtration rate, glucose (fasting), calcium, sodium, potassium. chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, direct and indirect bilirubin, gamma-glutamyl transferase, alkaline phosphatase, creatine kinase, uric acid, albumin and total protein. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.

Outcome measures

Measure	Cohort 1: PF-06954522 Dose Level C n=11 Participants Participants received PF-06954522 dose level C in fasted state.	Cohort 1: PF-06954522 Dose Level D n=2 Participants Participants received PF-06954522 dose level D in fasted state.	Cohort 1: PF-06954522 Dose Level D (Fed State High Fat Meal) n=4 Participants Participants received PF-06954522 dose level D in fed state with a high fat meal.	Cohort 1: PF-06954522 Dose Level E n=6 Participants Participants received PF-06954522 dose level E in fasted state.	Cohort 1: PF-06954522 Dose Level F n=6 Participants Participants received PF-06954522 dose level F in fasted state.	Cohort 1 and 2: Placebo (Fasted State) n=4 Participants Participants received PF-06954522 matching placebo in fasted state.	Cohort 1 and 2: Placebo (Fed State) n=5 Participants Participants received PF-06954522 matching placebo in fed state with high fat meal.
Cohort 2: Number of Participants With Clinical Chemistry Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	3 Participants	0 Participants	0 Participants	2 Participants	1 Participants	0 Participants	2 Participants

PRIMARY outcome

Timeframe: From Day 1 up to 35 days after last of study drug (maximum up to approximately 64 days)

Population: Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention.

Planned chemistry laboratory tests included: blood urea nitrogen, creatinine, cystatin C, estimated glomerular filtration rate, glucose (fasting), calcium, sodium, potassium. chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, direct and indirect bilirubin, gamma-glutamyl transferase, alkaline phosphatase, creatine kinase, uric acid, albumin and total protein. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.

Outcome measures

Measure	Cohort 1: PF-06954522 Dose Level C n=4 Participants Participants received PF-06954522 dose level C in fasted state.	Cohort 1: PF-06954522 Dose Level D n=2 Participants Participants received PF-06954522 dose level D in fasted state.	Cohort 1: PF-06954522 Dose Level D (Fed State High Fat Meal) n=4 Participants Participants received PF-06954522 dose level D in fed state with a high fat meal.	Cohort 1: PF-06954522 Dose Level E n=4 Participants Participants received PF-06954522 dose level E in fasted state.	Cohort 1: PF-06954522 Dose Level F n=3 Participants Participants received PF-06954522 dose level F in fasted state.	Cohort 1 and 2: Placebo (Fasted State) Participants received PF-06954522 matching placebo in fasted state.	Cohort 1 and 2: Placebo (Fed State) Participants received PF-06954522 matching placebo in fed state with high fat meal.
Cohort 3: Number of Participants With Clinical Chemistry Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	—	—

PRIMARY outcome

Timeframe: From Day 1 up to 35 days after last of study drug (maximum up to approximately 88 days)

Population: Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention.

Planned urinalysis laboratory tests included: pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen and urine bilirubin. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.

Outcome measures

Measure	Cohort 1: PF-06954522 Dose Level C n=7 Participants Participants received PF-06954522 dose level C in fasted state.	Cohort 1: PF-06954522 Dose Level D n=8 Participants Participants received PF-06954522 dose level D in fasted state.	Cohort 1: PF-06954522 Dose Level D (Fed State High Fat Meal) n=8 Participants Participants received PF-06954522 dose level D in fed state with a high fat meal.	Cohort 1: PF-06954522 Dose Level E n=8 Participants Participants received PF-06954522 dose level E in fasted state.	Cohort 1: PF-06954522 Dose Level F n=6 Participants Participants received PF-06954522 dose level F in fasted state.	Cohort 1 and 2: Placebo (Fasted State) n=11 Participants Participants received PF-06954522 matching placebo in fasted state.	Cohort 1 and 2: Placebo (Fed State) n=4 Participants Participants received PF-06954522 matching placebo in fed state with high fat meal.
Cohort 1: Number of Participants With Urinalysis Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	2 Participants	3 Participants	6 Participants	3 Participants	3 Participants	5 Participants	2 Participants

PRIMARY outcome

Timeframe: From Day 1 up to 35 days after last of study drug (maximum up to approximately 76 days)

Population: Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention.

Planned urinalysis laboratory tests included: pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen and urine bilirubin. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.

Outcome measures

Measure	Cohort 1: PF-06954522 Dose Level C n=11 Participants Participants received PF-06954522 dose level C in fasted state.	Cohort 1: PF-06954522 Dose Level D n=2 Participants Participants received PF-06954522 dose level D in fasted state.	Cohort 1: PF-06954522 Dose Level D (Fed State High Fat Meal) n=4 Participants Participants received PF-06954522 dose level D in fed state with a high fat meal.	Cohort 1: PF-06954522 Dose Level E n=6 Participants Participants received PF-06954522 dose level E in fasted state.	Cohort 1: PF-06954522 Dose Level F n=6 Participants Participants received PF-06954522 dose level F in fasted state.	Cohort 1 and 2: Placebo (Fasted State) n=4 Participants Participants received PF-06954522 matching placebo in fasted state.	Cohort 1 and 2: Placebo (Fed State) n=5 Participants Participants received PF-06954522 matching placebo in fed state with high fat meal.
Cohort 2: Number of Participants With Urinalysis Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	5 Participants	1 Participants	2 Participants	2 Participants	5 Participants	1 Participants	3 Participants

PRIMARY outcome

Timeframe: From Day 1 up to 35 days after last of study drug (maximum up to approximately 64 days)

Population: Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention.

Planned urinalysis laboratory tests included: pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen and urine bilirubin. The number of participants with results meeting pre-specified criteria (without regard to baseline abnormality) is reported.

Outcome measures

Measure	Cohort 1: PF-06954522 Dose Level C n=4 Participants Participants received PF-06954522 dose level C in fasted state.	Cohort 1: PF-06954522 Dose Level D n=2 Participants Participants received PF-06954522 dose level D in fasted state.	Cohort 1: PF-06954522 Dose Level D (Fed State High Fat Meal) n=4 Participants Participants received PF-06954522 dose level D in fed state with a high fat meal.	Cohort 1: PF-06954522 Dose Level E n=4 Participants Participants received PF-06954522 dose level E in fasted state.	Cohort 1: PF-06954522 Dose Level F n=3 Participants Participants received PF-06954522 dose level F in fasted state.	Cohort 1 and 2: Placebo (Fasted State) Participants received PF-06954522 matching placebo in fasted state.	Cohort 1 and 2: Placebo (Fed State) Participants received PF-06954522 matching placebo in fed state with high fat meal.
Cohort 3: Number of Participants With Urinalysis Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	0 Participants	0 Participants	2 Participants	1 Participants	1 Participants	—	—

PRIMARY outcome

Timeframe: From Day 1 up to 35 days after last of study drug (maximum up to approximately 88 days)

Population: Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention.

Vital signs parameters were summarized according to pre-specified categorization of data: supine systolic blood pressure: Value less than (<) 90 millimeter of mercury (mmHg), increase or decrease from baseline >= 30mmHg, supine diastolic blood pressure: value <50 mmHg, increase or decrease from baseline >= 20mmHg and supine pulse rate: Value < 40 beats per minute bpm or > 120bpm.

Outcome measures

Measure	Cohort 1: PF-06954522 Dose Level C n=7 Participants Participants received PF-06954522 dose level C in fasted state.	Cohort 1: PF-06954522 Dose Level D n=8 Participants Participants received PF-06954522 dose level D in fasted state.	Cohort 1: PF-06954522 Dose Level D (Fed State High Fat Meal) n=8 Participants Participants received PF-06954522 dose level D in fed state with a high fat meal.	Cohort 1: PF-06954522 Dose Level E n=8 Participants Participants received PF-06954522 dose level E in fasted state.	Cohort 1: PF-06954522 Dose Level F n=6 Participants Participants received PF-06954522 dose level F in fasted state.	Cohort 1 and 2: Placebo (Fasted State) n=11 Participants Participants received PF-06954522 matching placebo in fasted state.	Cohort 1 and 2: Placebo (Fed State) n=4 Participants Participants received PF-06954522 matching placebo in fed state with high fat meal.
Cohort 1: Number of Participants According to Categorization of Vital Signs Abnormalities Data Supine diastolic blood pressure: Increase from baseline >= 20mmHg	0 Participants	3 Participants	0 Participants	4 Participants	0 Participants	0 Participants	0 Participants
Cohort 1: Number of Participants According to Categorization of Vital Signs Abnormalities Data Supine systolic blood pressure: Value < 90mmHg	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 1: Number of Participants According to Categorization of Vital Signs Abnormalities Data Supine systolic blood pressure : Increase from baseline >= 30mmHg	1 Participants	1 Participants	0 Participants	3 Participants	1 Participants	0 Participants	0 Participants
Cohort 1: Number of Participants According to Categorization of Vital Signs Abnormalities Data Supine pulse rate: Value > 120bpm	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From Day 1 up to 35 days after last of study drug (maximum up to approximately 76 days)

Population: Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention.

Vital signs parameters were summarized according to pre-specified categorization of data: supine systolic blood pressure: Value less than (<) 90 millimeter of mercury (mmHg), increase or decrease from baseline >= 30mmHg, supine diastolic blood pressure: value <50 mmHg, increase or decrease from baseline >= 20mmHg and supine pulse rate: Value < 40 beats per minute bpm or > 120bpm.

Outcome measures

Measure	Cohort 1: PF-06954522 Dose Level C n=11 Participants Participants received PF-06954522 dose level C in fasted state.	Cohort 1: PF-06954522 Dose Level D n=2 Participants Participants received PF-06954522 dose level D in fasted state.	Cohort 1: PF-06954522 Dose Level D (Fed State High Fat Meal) n=4 Participants Participants received PF-06954522 dose level D in fed state with a high fat meal.	Cohort 1: PF-06954522 Dose Level E n=6 Participants Participants received PF-06954522 dose level E in fasted state.	Cohort 1: PF-06954522 Dose Level F n=6 Participants Participants received PF-06954522 dose level F in fasted state.	Cohort 1 and 2: Placebo (Fasted State) n=4 Participants Participants received PF-06954522 matching placebo in fasted state.	Cohort 1 and 2: Placebo (Fed State) n=5 Participants Participants received PF-06954522 matching placebo in fed state with high fat meal.
Cohort 2: Number of Participants According to Categorization of Vital Signs Abnormalities Data Supine systolic blood pressure: Value < 90mmHg	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Cohort 2: Number of Participants According to Categorization of Vital Signs Abnormalities Data Supine systolic blood pressure : Increase from baseline >= 30mmHg	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Cohort 2: Number of Participants According to Categorization of Vital Signs Abnormalities Data Supine diastolic blood pressure: Increase from baseline >= 20mmHg	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants
Cohort 2: Number of Participants According to Categorization of Vital Signs Abnormalities Data Supine pulse rate: Value > 120bpm	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From Day 1 up to 35 days after last of study drug (maximum up to approximately 64 days)

Population: Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention.

Vital signs parameters were summarized according to pre-specified categorization of data: supine systolic blood pressure: Value less than (<) 90 millimeter of mercury (mmHg), increase or decrease from baseline >= 30mmHg, supine diastolic blood pressure: value <50 mmHg and increase or decrease from baseline >= 20mmHg.

Outcome measures

Measure	Cohort 1: PF-06954522 Dose Level C n=4 Participants Participants received PF-06954522 dose level C in fasted state.	Cohort 1: PF-06954522 Dose Level D n=2 Participants Participants received PF-06954522 dose level D in fasted state.	Cohort 1: PF-06954522 Dose Level D (Fed State High Fat Meal) n=4 Participants Participants received PF-06954522 dose level D in fed state with a high fat meal.	Cohort 1: PF-06954522 Dose Level E n=4 Participants Participants received PF-06954522 dose level E in fasted state.	Cohort 1: PF-06954522 Dose Level F n=3 Participants Participants received PF-06954522 dose level F in fasted state.	Cohort 1 and 2: Placebo (Fasted State) Participants received PF-06954522 matching placebo in fasted state.	Cohort 1 and 2: Placebo (Fed State) Participants received PF-06954522 matching placebo in fed state with high fat meal.
Cohort 3: Number of Participants According to Categorization of Vital Signs Abnormalities Data Supine systolic blood pressure: Value < 90mmHg	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	—	—
Cohort 3: Number of Participants According to Categorization of Vital Signs Abnormalities Data Supine systolic blood pressure : Increase from baseline >= 30mmHg	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants	—	—
Cohort 3: Number of Participants According to Categorization of Vital Signs Abnormalities Data Supine diastolic blood pressure: Increase from baseline >= 20mmHg	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	—	—

PRIMARY outcome

Timeframe: From Day 1 up to 35 days after last of study drug (maximum up to approximately 88 days)

Population: Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention.

Pre-specified ECG abnormalities criteria : PR interval millisecond (msec), value >=300, baseline > 200 and percentage (%) change >=25%, baseline <=200 and percentage change >=50%; QRS duration (msec): value >=140, % change>= 50%; corrected QT interval using Fridericia's formula (QTcF) (msec): 450 < value <= 480, 480<= value <500, value >=500, 30<= change <60 and change > 60.

Outcome measures

Measure	Cohort 1: PF-06954522 Dose Level C n=7 Participants Participants received PF-06954522 dose level C in fasted state.	Cohort 1: PF-06954522 Dose Level D n=8 Participants Participants received PF-06954522 dose level D in fasted state.	Cohort 1: PF-06954522 Dose Level D (Fed State High Fat Meal) n=8 Participants Participants received PF-06954522 dose level D in fed state with a high fat meal.	Cohort 1: PF-06954522 Dose Level E n=8 Participants Participants received PF-06954522 dose level E in fasted state.	Cohort 1: PF-06954522 Dose Level F n=6 Participants Participants received PF-06954522 dose level F in fasted state.	Cohort 1 and 2: Placebo (Fasted State) n=11 Participants Participants received PF-06954522 matching placebo in fasted state.	Cohort 1 and 2: Placebo (Fed State) n=4 Participants Participants received PF-06954522 matching placebo in fed state with high fat meal.
Cohort 1: Number of Participants According to Categorization of Electrocardiogram (ECG) Abnormalities Parameters QTcF: value >=500	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 1: Number of Participants According to Categorization of Electrocardiogram (ECG) Abnormalities Parameters QTcF: 30<= change <60	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 1: Number of Participants According to Categorization of Electrocardiogram (ECG) Abnormalities Parameters QTcF: change >60	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 1: Number of Participants According to Categorization of Electrocardiogram (ECG) Abnormalities Parameters PR interval: value >=300	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 1: Number of Participants According to Categorization of Electrocardiogram (ECG) Abnormalities Parameters PR interval: baseline > 200 and % change >=25%	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 1: Number of Participants According to Categorization of Electrocardiogram (ECG) Abnormalities Parameters PR interval: baseline <=200 and percentage change >=50%	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 1: Number of Participants According to Categorization of Electrocardiogram (ECG) Abnormalities Parameters QRS duration: value >=140	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 1: Number of Participants According to Categorization of Electrocardiogram (ECG) Abnormalities Parameters QRS duration: % change>= 50%	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 1: Number of Participants According to Categorization of Electrocardiogram (ECG) Abnormalities Parameters QTcF: 450 < value <= 480	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 1: Number of Participants According to Categorization of Electrocardiogram (ECG) Abnormalities Parameters QTcF: 480<= value <500	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From Day 1 up to 35 days after last of study drug (maximum up to approximately 76 days)

Population: Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention.

Pre-specified ECG abnormalities criteria : PR interval millisecond (msec), value >=300, baseline > 200 and percentage (%) change >=25%, baseline <=200 and percentage change >=50%; QRS duration (msec): value >=140, % change>= 50%; corrected QT interval using Fridericia's formula (QTcF) (msec): 450 < value <= 480, 480<= value <500, value >=500, 30<= change <60 and change > 60.

Outcome measures

Measure	Cohort 1: PF-06954522 Dose Level C n=11 Participants Participants received PF-06954522 dose level C in fasted state.	Cohort 1: PF-06954522 Dose Level D n=2 Participants Participants received PF-06954522 dose level D in fasted state.	Cohort 1: PF-06954522 Dose Level D (Fed State High Fat Meal) n=4 Participants Participants received PF-06954522 dose level D in fed state with a high fat meal.	Cohort 1: PF-06954522 Dose Level E n=6 Participants Participants received PF-06954522 dose level E in fasted state.	Cohort 1: PF-06954522 Dose Level F n=6 Participants Participants received PF-06954522 dose level F in fasted state.	Cohort 1 and 2: Placebo (Fasted State) n=4 Participants Participants received PF-06954522 matching placebo in fasted state.	Cohort 1 and 2: Placebo (Fed State) n=5 Participants Participants received PF-06954522 matching placebo in fed state with high fat meal.
Cohort 2: Number of Participants According to Categorization of ECG Abnormalities Parameters QTcF: 30<= change <60	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 2: Number of Participants According to Categorization of ECG Abnormalities Parameters PR interval: value >=300	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 2: Number of Participants According to Categorization of ECG Abnormalities Parameters PR interval: baseline > 200 and % change >=25%	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 2: Number of Participants According to Categorization of ECG Abnormalities Parameters PR interval: baseline <=200 and percentage change >=50%	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 2: Number of Participants According to Categorization of ECG Abnormalities Parameters QRS duration: value >=140	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 2: Number of Participants According to Categorization of ECG Abnormalities Parameters QRS duration: % change>= 50%	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 2: Number of Participants According to Categorization of ECG Abnormalities Parameters QTcF: 450 < value <= 480	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 2: Number of Participants According to Categorization of ECG Abnormalities Parameters QTcF: 480<= value <500	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 2: Number of Participants According to Categorization of ECG Abnormalities Parameters QTcF: value >=500	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Cohort 2: Number of Participants According to Categorization of ECG Abnormalities Parameters QTcF: change >60	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From Day 1 up to 35 days after last of study drug (maximum up to approximately 64 days)

Population: Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention.

Pre-specified ECG abnormalities criteria : PR interval millisecond (msec), value >=300, baseline > 200 and percentage (%) change >=25%, baseline <=200 and percentage change >=50%; QRS duration (msec): value >=140, % change>= 50%; corrected QT interval using Fridericia's formula (QTcF) (msec): 450 < value <= 480, 480<= value <500, value >=500, 30<= change <60 and change > 60.

Outcome measures

Measure	Cohort 1: PF-06954522 Dose Level C n=4 Participants Participants received PF-06954522 dose level C in fasted state.	Cohort 1: PF-06954522 Dose Level D n=2 Participants Participants received PF-06954522 dose level D in fasted state.	Cohort 1: PF-06954522 Dose Level D (Fed State High Fat Meal) n=4 Participants Participants received PF-06954522 dose level D in fed state with a high fat meal.	Cohort 1: PF-06954522 Dose Level E n=4 Participants Participants received PF-06954522 dose level E in fasted state.	Cohort 1: PF-06954522 Dose Level F n=3 Participants Participants received PF-06954522 dose level F in fasted state.	Cohort 1 and 2: Placebo (Fasted State) Participants received PF-06954522 matching placebo in fasted state.	Cohort 1 and 2: Placebo (Fed State) Participants received PF-06954522 matching placebo in fed state with high fat meal.
Cohort 3: Number of Participants According to Categorization of ECG Abnormalities Parameters PR interval: baseline > 200 and % change >=25%	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants According to Categorization of ECG Abnormalities Parameters QRS duration: % change>= 50%	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants According to Categorization of ECG Abnormalities Parameters QTcF: 450 <value <=480	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants According to Categorization of ECG Abnormalities Parameters QTcF: 30<= change <60	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants According to Categorization of ECG Abnormalities Parameters PR interval: value >=300	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants According to Categorization of ECG Abnormalities Parameters PR interval: baseline <=200 and percentage change >=50%	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants According to Categorization of ECG Abnormalities Parameters QRS duration: value >=140	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants According to Categorization of ECG Abnormalities Parameters QTcF: 480<= value <500	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants According to Categorization of ECG Abnormalities Parameters QTcF: value >=500	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Cohort 3: Number of Participants According to Categorization of ECG Abnormalities Parameters QTcF: change >60 msec	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: From 0 hours (pre-dose) to 72 hours following a single dose on Day 1

Population: Pharmacokinetic (PK) parameter set included all participants who were randomly assigned to study intervention and received at least 1 dose of study intervention and had at least 1 of the PK parameters of interest calculated. Data for cohorts and periods included in the pre-specified secondary outcome measure are reported here (i.e., cohort 1, plasma concentration parameters observed following administration of PF-06954522 in the fasted state).

AUClast was determined by using linear/log trapezoidal method.

Outcome measures

Measure	Cohort 1: PF-06954522 Dose Level C n=7 Participants Participants received PF-06954522 dose level C in fasted state.	Cohort 1: PF-06954522 Dose Level D n=8 Participants Participants received PF-06954522 dose level D in fasted state.	Cohort 1: PF-06954522 Dose Level D (Fed State High Fat Meal) n=8 Participants Participants received PF-06954522 dose level D in fed state with a high fat meal.	Cohort 1: PF-06954522 Dose Level E n=6 Participants Participants received PF-06954522 dose level E in fasted state.	Cohort 1: PF-06954522 Dose Level F Participants received PF-06954522 dose level F in fasted state.	Cohort 1 and 2: Placebo (Fasted State) Participants received PF-06954522 matching placebo in fasted state.	Cohort 1 and 2: Placebo (Fed State) Participants received PF-06954522 matching placebo in fed state with high fat meal.
Cohort 1: Area Under the Plasma Concentration-Time Profile From Time Zero (0) to Time of Last Quantifiable Concentration (AUClast) of PF-06954522	1394 Nanogram*hour per milliliter (ng*hr/mL) Geometric Coefficient of Variation 37	4252 Nanogram*hour per milliliter (ng*hr/mL) Geometric Coefficient of Variation 43	7503 Nanogram*hour per milliliter (ng*hr/mL) Geometric Coefficient of Variation 60	5631 Nanogram*hour per milliliter (ng*hr/mL) Geometric Coefficient of Variation 40	—	—	—

SECONDARY outcome

Timeframe: From 0 hours (pre-dose) to 72 hours following a single dose on Day 1

Population: PK parameter set included all participants who were randomly assigned to study intervention and received at least 1 dose of study intervention and had at least 1 of the PK parameters of interest calculated. Data for cohorts and periods included in the pre-specified secondary outcome measure are reported here (i.e., cohort 2, plasma concentration parameters observed following administration of PF-06954522 in the fasted state).

AUClast was determined by using linear/log trapezoidal method.

Outcome measures

Measure	Cohort 1: PF-06954522 Dose Level C n=6 Participants Participants received PF-06954522 dose level C in fasted state.	Cohort 1: PF-06954522 Dose Level D n=5 Participants Participants received PF-06954522 dose level D in fasted state.	Cohort 1: PF-06954522 Dose Level D (Fed State High Fat Meal) Participants received PF-06954522 dose level D in fed state with a high fat meal.	Cohort 1: PF-06954522 Dose Level E Participants received PF-06954522 dose level E in fasted state.	Cohort 1: PF-06954522 Dose Level F Participants received PF-06954522 dose level F in fasted state.	Cohort 1 and 2: Placebo (Fasted State) Participants received PF-06954522 matching placebo in fasted state.	Cohort 1 and 2: Placebo (Fed State) Participants received PF-06954522 matching placebo in fed state with high fat meal.
Cohort 2: AUClast of PF-06954522	827.2 ng*hr/mL Geometric Coefficient of Variation 24	12630 ng*hr/mL Geometric Coefficient of Variation 40	—	—	—	—	—

SECONDARY outcome

Timeframe: From 0 hours (pre-dose) to 72 hours following a single dose on Day 1

Population: PK parameter set included all participants who were randomly assigned to study intervention and received at least 1 dose of study intervention and had at least 1 of the PK parameters of interest calculated. Data for cohorts and periods included in the pre-specified secondary outcome measure are reported here (i.e., cohort 1, plasma concentration parameters observed following administration of PF-06954522 in the fasted state).

Cmax of PF-06954522 was reported in this outcome measure.

Outcome measures

Measure	Cohort 1: PF-06954522 Dose Level C n=7 Participants Participants received PF-06954522 dose level C in fasted state.	Cohort 1: PF-06954522 Dose Level D n=8 Participants Participants received PF-06954522 dose level D in fasted state.	Cohort 1: PF-06954522 Dose Level D (Fed State High Fat Meal) n=8 Participants Participants received PF-06954522 dose level D in fed state with a high fat meal.	Cohort 1: PF-06954522 Dose Level E n=6 Participants Participants received PF-06954522 dose level E in fasted state.	Cohort 1: PF-06954522 Dose Level F Participants received PF-06954522 dose level F in fasted state.	Cohort 1 and 2: Placebo (Fasted State) Participants received PF-06954522 matching placebo in fasted state.	Cohort 1 and 2: Placebo (Fed State) Participants received PF-06954522 matching placebo in fed state with high fat meal.
Cohort 1: Maximum Observed Concentration (Cmax) of PF-06954522	112.9 Nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 40	377.7 Nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 38	837.6 Nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 53	522.9 Nanogram per milliliter (ng/mL) Geometric Coefficient of Variation 55	—	—	—

SECONDARY outcome

Timeframe: From 0 hours (pre-dose) to 72 hours following a single dose on Day 1

Population: PK parameter set included all participants who were randomly assigned to study intervention and received at least 1 dose of study intervention and had at least 1 of the PK parameters of interest calculated. Data for cohorts and periods included in the pre-specified secondary outcome measure are reported here (i.e., cohort 2, plasma concentration parameters observed following administration of PF-06954522 in the fasted state).

Cmax of PF-06954522 was reported in this outcome measure.

Outcome measures

Measure	Cohort 1: PF-06954522 Dose Level C n=6 Participants Participants received PF-06954522 dose level C in fasted state.	Cohort 1: PF-06954522 Dose Level D n=5 Participants Participants received PF-06954522 dose level D in fasted state.	Cohort 1: PF-06954522 Dose Level D (Fed State High Fat Meal) Participants received PF-06954522 dose level D in fed state with a high fat meal.	Cohort 1: PF-06954522 Dose Level E Participants received PF-06954522 dose level E in fasted state.	Cohort 1: PF-06954522 Dose Level F Participants received PF-06954522 dose level F in fasted state.	Cohort 1 and 2: Placebo (Fasted State) Participants received PF-06954522 matching placebo in fasted state.	Cohort 1 and 2: Placebo (Fed State) Participants received PF-06954522 matching placebo in fed state with high fat meal.
Cohort 2: Cmax of PF-06954522	86.82 ng/mL Geometric Coefficient of Variation 28	1088 ng/mL Geometric Coefficient of Variation 57	—	—	—	—	—

SECONDARY outcome

Timeframe: From 0 hours (pre-dose) to 72 hours following a single dose on Day 1

Population: PK parameter set included all participants who were randomly assigned to study intervention and received at least 1 dose of study intervention and had at least 1 of the PK parameters of interest calculated. Data for cohorts and periods included in the pre-specified secondary outcome measure are reported here (i.e., cohort 1, plasma concentration parameters observed following administration of PF-06954522 in the fasted state).

Tmax of PF-06954522 was reported in this outcome measure.

Outcome measures

Measure	Cohort 1: PF-06954522 Dose Level C n=7 Participants Participants received PF-06954522 dose level C in fasted state.	Cohort 1: PF-06954522 Dose Level D n=8 Participants Participants received PF-06954522 dose level D in fasted state.	Cohort 1: PF-06954522 Dose Level D (Fed State High Fat Meal) n=8 Participants Participants received PF-06954522 dose level D in fed state with a high fat meal.	Cohort 1: PF-06954522 Dose Level E n=6 Participants Participants received PF-06954522 dose level E in fasted state.	Cohort 1: PF-06954522 Dose Level F Participants received PF-06954522 dose level F in fasted state.	Cohort 1 and 2: Placebo (Fasted State) Participants received PF-06954522 matching placebo in fasted state.	Cohort 1 and 2: Placebo (Fed State) Participants received PF-06954522 matching placebo in fed state with high fat meal.
Cohort 1: Time to Maximum Observed Concentration (Tmax) of PF-06954522	1.02 Hours Interval 1.0 to 2.0	3.00 Hours Interval 1.02 to 12.0	2.02 Hours Interval 1.0 to 6.0	1.09 Hours Interval 1.03 to 4.0	—	—	—

SECONDARY outcome

Timeframe: From 0 hours (pre-dose) to 72 hours following a single dose on Day 1

Population: PK parameter set included all participants who were randomly assigned to study intervention and received at least 1 dose of study intervention and had at least 1 of the PK parameters of interest calculated. Data for cohorts and periods included in the pre-specified secondary outcome measure are reported here (i.e., cohort 2, plasma concentration parameters observed following administration of PF-06954522 in the fasted state).

Tmax of PF-06954522 was reported in this outcome measure.

Outcome measures

Measure	Cohort 1: PF-06954522 Dose Level C n=6 Participants Participants received PF-06954522 dose level C in fasted state.	Cohort 1: PF-06954522 Dose Level D n=5 Participants Participants received PF-06954522 dose level D in fasted state.	Cohort 1: PF-06954522 Dose Level D (Fed State High Fat Meal) Participants received PF-06954522 dose level D in fed state with a high fat meal.	Cohort 1: PF-06954522 Dose Level E Participants received PF-06954522 dose level E in fasted state.	Cohort 1: PF-06954522 Dose Level F Participants received PF-06954522 dose level F in fasted state.	Cohort 1 and 2: Placebo (Fasted State) Participants received PF-06954522 matching placebo in fasted state.	Cohort 1 and 2: Placebo (Fed State) Participants received PF-06954522 matching placebo in fed state with high fat meal.
Cohort 2: Tmax of PF-06954522	2.04 Hours Interval 1.0 to 4.05	1.00 Hours Interval 0.6 to 4.0	—	—	—	—	—

SECONDARY outcome

Timeframe: From 0 hours (pre-dose) to 72 hours following a single dose on Day 1

Population: PK parameter set included all participants who were randomly assigned to study intervention and received at least 1 dose of study intervention and had at least 1 of the PK parameters of interest calculated. Data for cohorts and periods included in the pre-specified secondary outcome measure are reported here (i.e., cohort 1, plasma concentration parameters observed following administration of PF-06954522 in the fasted state).

Area under the plasma concentration-time profile from time 0 extrapolated to infinite time. It was determined by AUClast +(Clast*/kel), where Clast is the predicted plasma concentration at the last quantifiable timepoint estimated from the log-linear regression analysis.

Outcome measures

Measure	Cohort 1: PF-06954522 Dose Level C n=7 Participants Participants received PF-06954522 dose level C in fasted state.	Cohort 1: PF-06954522 Dose Level D n=8 Participants Participants received PF-06954522 dose level D in fasted state.	Cohort 1: PF-06954522 Dose Level D (Fed State High Fat Meal) n=8 Participants Participants received PF-06954522 dose level D in fed state with a high fat meal.	Cohort 1: PF-06954522 Dose Level E n=6 Participants Participants received PF-06954522 dose level E in fasted state.	Cohort 1: PF-06954522 Dose Level F Participants received PF-06954522 dose level F in fasted state.	Cohort 1 and 2: Placebo (Fasted State) Participants received PF-06954522 matching placebo in fasted state.	Cohort 1 and 2: Placebo (Fed State) Participants received PF-06954522 matching placebo in fed state with high fat meal.
Cohort 1: Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf) of PF-06954522	1415 Nanogram*hour per milliliter (ng.hr/mL) Geometric Coefficient of Variation 36	4283 Nanogram*hour per milliliter (ng.hr/mL) Geometric Coefficient of Variation 43	7576 Nanogram*hour per milliliter (ng.hr/mL) Geometric Coefficient of Variation 60	5667 Nanogram*hour per milliliter (ng.hr/mL) Geometric Coefficient of Variation 40	—	—	—

SECONDARY outcome

Timeframe: From 0 hours (pre-dose) to 72 hours following a single dose on Day 1

Population: PK parameter set: all participants who were randomly assigned to study intervention \& received at least 1 dose of study intervention \& had at least 1 of PK parameters of interest calculated. "Overall Number of Participants Analyzed" signifies participants evaluable for this parameter. Data for cohorts and periods included in pre-specified secondary outcome measure are reported here (i.e., cohort 2, plasma concentration parameters observed following administration of PF-06954522 in fasted state).

Area under the plasma concentration-time profile from time 0 extrapolated to infinite time. It was determined by AUClast +(Clast*/kel), where Clast is the predicted plasma concentration at the last quantifiable timepoint estimated from the log-linear regression analysis.

Outcome measures

Measure	Cohort 1: PF-06954522 Dose Level C n=6 Participants Participants received PF-06954522 dose level C in fasted state.	Cohort 1: PF-06954522 Dose Level D n=5 Participants Participants received PF-06954522 dose level D in fasted state.	Cohort 1: PF-06954522 Dose Level D (Fed State High Fat Meal) Participants received PF-06954522 dose level D in fed state with a high fat meal.	Cohort 1: PF-06954522 Dose Level E Participants received PF-06954522 dose level E in fasted state.	Cohort 1: PF-06954522 Dose Level F Participants received PF-06954522 dose level F in fasted state.	Cohort 1 and 2: Placebo (Fasted State) Participants received PF-06954522 matching placebo in fasted state.	Cohort 1 and 2: Placebo (Fed State) Participants received PF-06954522 matching placebo in fed state with high fat meal.
Cohort 2: AUCinf of PF-06954522	846.6 ng.hr/mL Geometric Coefficient of Variation 23	12700 ng.hr/mL Geometric Coefficient of Variation 40	—	—	—	—	—

SECONDARY outcome

Timeframe: From 0 hours (pre-dose) to 72 hours following a single dose on Day 1

Population: PK parameter set included all participants who were randomly assigned to study intervention and received at least 1 dose of study intervention and had at least 1 of the PK parameters of interest calculated. Data for cohorts and periods included in the pre-specified secondary outcome measure are reported here (i.e., cohort 1, plasma concentration parameters observed following administration of PF-06954522 in the fasted state).

t1/2 was determined by Loge (2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.

Outcome measures

Measure	Cohort 1: PF-06954522 Dose Level C n=7 Participants Participants received PF-06954522 dose level C in fasted state.	Cohort 1: PF-06954522 Dose Level D n=8 Participants Participants received PF-06954522 dose level D in fasted state.	Cohort 1: PF-06954522 Dose Level D (Fed State High Fat Meal) n=8 Participants Participants received PF-06954522 dose level D in fed state with a high fat meal.	Cohort 1: PF-06954522 Dose Level E n=6 Participants Participants received PF-06954522 dose level E in fasted state.	Cohort 1: PF-06954522 Dose Level F Participants received PF-06954522 dose level F in fasted state.	Cohort 1 and 2: Placebo (Fasted State) Participants received PF-06954522 matching placebo in fasted state.	Cohort 1 and 2: Placebo (Fed State) Participants received PF-06954522 matching placebo in fed state with high fat meal.
Cohort 1: Terminal Half-Life (t1/2) of PF-06954522	6.313 Hours Standard Deviation 1.4278	8.444 Hours Standard Deviation 3.3668	7.264 Hours Standard Deviation 2.8676	5.958 Hours Standard Deviation 1.6741	—	—	—

SECONDARY outcome

Timeframe: From 0 hours (pre-dose) to 72 hours following a single dose on Day 1

Population: PK parameter set: all participants who were randomly assigned to study intervention \& received at least 1 dose of study intervention \& had at least 1 of PK parameters of interest calculated. "Overall Number of Participants Analyzed" signifies participants evaluable for this parameter. Data for cohorts and periods included in pre-specified secondary outcome measure are reported here (i.e., cohort 2, plasma concentration parameters observed following administration of PF-06954522 in fasted state).

t1/2was determined by Loge (2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.

Outcome measures

Measure	Cohort 1: PF-06954522 Dose Level C n=6 Participants Participants received PF-06954522 dose level C in fasted state.	Cohort 1: PF-06954522 Dose Level D n=5 Participants Participants received PF-06954522 dose level D in fasted state.	Cohort 1: PF-06954522 Dose Level D (Fed State High Fat Meal) Participants received PF-06954522 dose level D in fed state with a high fat meal.	Cohort 1: PF-06954522 Dose Level E Participants received PF-06954522 dose level E in fasted state.	Cohort 1: PF-06954522 Dose Level F Participants received PF-06954522 dose level F in fasted state.	Cohort 1 and 2: Placebo (Fasted State) Participants received PF-06954522 matching placebo in fasted state.	Cohort 1 and 2: Placebo (Fed State) Participants received PF-06954522 matching placebo in fed state with high fat meal.
Cohort 2: t1/2 of PF-06954522	5.918 Hours Standard Deviation 0.74714	7.766 Hours Standard Deviation 2.6585	—	—	—	—	—

Adverse Events

Cohort 1 and 2: Placebo (Fasted State)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Cohort 1 and 2: Placebo (Fed State)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Cohort 1: PF-06954522 Dose Level C

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Cohort 1: PF-06954522 Dose Level D

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Cohort 1: PF-06954522 Dose Level D (Fed State High Fat Meal)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Cohort 1: PF-06954522 Dose Level E

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Cohort 1: PF-06954522 Dose Level F

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Cohort 2: Placebo Standard Meal

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort 2: PF-06954522 Dose Level A (Fed State-standard Meal)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Cohort 2: PF-06954522 Dose Level B

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Cohort 2: PF-06954522 Dose Level B (Fed State High-fat Meal)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort 2: PF-06954522 Dose Level F

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Cohort 3: Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Cohort 3: Placebo (Fed)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Cohort 3: PF-06954522 Dose Level D

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Cohort 3: PF-06954522 Dose Level D (Fed State High-fat Meal)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Cohort 3: PF-06954522 Dose Level E

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Cohort 1 and 2: Placebo (Fasted State) n=11 participants at risk Participants received PF-06954522 matching placebo in fasted state.	Cohort 1 and 2: Placebo (Fed State) n=4 participants at risk Participants received PF-06954522 matching placebo in fed state high fat meal.	Cohort 1: PF-06954522 Dose Level C n=7 participants at risk Participants received PF-06954522 dose level C in fasted state.	Cohort 1: PF-06954522 Dose Level D n=8 participants at risk Participants received PF-06954522 dose level D in fasted state.	Cohort 1: PF-06954522 Dose Level D (Fed State High Fat Meal) n=8 participants at risk Participants received PF-06954522 dose level D in fed state with a high fat meal.	Cohort 1: PF-06954522 Dose Level E n=8 participants at risk Participants received PF-06954522 dose level E in fasted state.	Cohort 1: PF-06954522 Dose Level F n=6 participants at risk Participants received PF-06954522 dose level F in fasted state.	Cohort 2: Placebo Standard Meal n=2 participants at risk Participants received PF-06954522 matching placebo in the standard meal.	Cohort 2: PF-06954522 Dose Level A (Fed State-standard Meal) n=6 participants at risk Participants received PF-06954522 dose level A in the fed state standard-meal.	Cohort 2: PF-06954522 Dose Level B n=6 participants at risk Participants received PF-06954522 dose level B in fasted state.	Cohort 2: PF-06954522 Dose Level B (Fed State High-fat Meal) n=4 participants at risk Participants received PF-06954522 dose level B in the fed state high-fat meal.	Cohort 2: PF-06954522 Dose Level F n=5 participants at risk Participants received PF-06954522 dose level F in fasted state.	Cohort 3: Placebo n=4 participants at risk Japanese participants received a single dose of matching placebo of PF-06954522 on Day 1 of Cohort 3.	Cohort 3: Placebo (Fed) n=2 participants at risk Japanese participants received a single dose of matching placebo to PF-06954522 in the fed state high-fat meal on Day 1 of Cohort 3.	Cohort 3: PF-06954522 Dose Level D n=4 participants at risk Japanese participants received PF-06954522 dose level D on Day 1 of Cohort 3.	Cohort 3: PF-06954522 Dose Level D (Fed State High-fat Meal) n=4 participants at risk Japanese participants received PF-06954522 dose level D in the fed state high-fat meal on Day 1 of Cohort 3.	Cohort 3: PF-06954522 Dose Level E n=3 participants at risk Japanese participants received PF-06954522 dose level E on Day 1 of Cohort 3.
Eye disorders Dry eye	0.00% 0/11 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/7 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/5 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	25.0% 1/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/3 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.
Eye disorders Extraocular muscle disorder	0.00% 0/11 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	14.3% 1/7 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/5 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/3 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.
Gastrointestinal disorders Abdominal pain	0.00% 0/11 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/7 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	16.7% 1/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	16.7% 1/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	20.0% 1/5 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/3 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.
Gastrointestinal disorders Abdominal pain lower	9.1% 1/11 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/7 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/5 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/3 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.
Gastrointestinal disorders Constipation	0.00% 0/11 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/7 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	12.5% 1/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	16.7% 1/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/5 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	25.0% 1/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	25.0% 1/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	25.0% 1/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/3 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.
Gastrointestinal disorders Diarrhoea	0.00% 0/11 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/7 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	12.5% 1/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/5 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/3 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.
Gastrointestinal disorders Dyspepsia	0.00% 0/11 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/7 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/5 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	25.0% 1/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/3 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.
Gastrointestinal disorders Faeces soft	0.00% 0/11 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/7 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/5 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	33.3% 1/3 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.
Gastrointestinal disorders Flatulence	0.00% 0/11 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/7 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	12.5% 1/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	20.0% 1/5 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/3 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/11 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/7 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	33.3% 2/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/5 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	25.0% 1/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	33.3% 1/3 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.
Gastrointestinal disorders Nausea	0.00% 0/11 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	42.9% 3/7 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	75.0% 6/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	62.5% 5/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	50.0% 4/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	66.7% 4/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	16.7% 1/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	60.0% 3/5 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	25.0% 1/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	75.0% 3/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	75.0% 3/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	66.7% 2/3 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.
Gastrointestinal disorders Vomiting	0.00% 0/11 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	14.3% 1/7 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	62.5% 5/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	50.0% 4/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	87.5% 7/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	66.7% 4/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	16.7% 1/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	80.0% 4/5 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	100.0% 4/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	75.0% 3/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	66.7% 2/3 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.
General disorders Chills	0.00% 0/11 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/7 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	12.5% 1/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	20.0% 1/5 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	66.7% 2/3 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.
General disorders Early satiety	0.00% 0/11 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/7 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/5 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	33.3% 1/3 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.
General disorders Fatigue	0.00% 0/11 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/7 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	25.0% 2/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/5 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	33.3% 1/3 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.
General disorders Pain	0.00% 0/11 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/7 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	12.5% 1/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/5 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/3 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.
General disorders Pyrexia	0.00% 0/11 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/7 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	12.5% 1/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/5 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	25.0% 1/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/3 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.
Infections and infestations Pharyngitis	0.00% 0/11 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	25.0% 1/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/7 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/5 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/3 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/11 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/7 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/5 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	50.0% 1/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	25.0% 1/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/3 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/11 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/7 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/5 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	50.0% 1/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/3 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.
Injury, poisoning and procedural complications Lip injury	0.00% 0/11 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/7 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	12.5% 1/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/5 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/3 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.
Injury, poisoning and procedural complications Scratch	0.00% 0/11 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/7 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/5 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	25.0% 1/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/3 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.
Injury, poisoning and procedural complications Wound	0.00% 0/11 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/7 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	12.5% 1/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/5 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/3 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.
Investigations Pancreatic enzymes increased	0.00% 0/11 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/7 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	20.0% 1/5 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/3 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.
Investigations Transaminases increased	0.00% 0/11 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/7 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	16.7% 1/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/5 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/3 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.
Investigations Urine amphetamine positive	0.00% 0/11 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/7 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	12.5% 1/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/5 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/3 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/11 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/7 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	25.0% 2/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	12.5% 1/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	37.5% 3/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	40.0% 2/5 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	25.0% 1/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	50.0% 2/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	33.3% 1/3 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.
Metabolism and nutrition disorders Food craving	0.00% 0/11 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/7 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	12.5% 1/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/5 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/3 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.
Nervous system disorders Brain fog	0.00% 0/11 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/7 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/5 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	25.0% 1/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	33.3% 1/3 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.
Nervous system disorders Dizziness	0.00% 0/11 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/7 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	12.5% 1/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	12.5% 1/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	16.7% 1/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/5 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	50.0% 2/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	25.0% 1/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	33.3% 1/3 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.
Nervous system disorders Headache	9.1% 1/11 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	14.3% 1/7 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	37.5% 3/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	37.5% 3/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	62.5% 5/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	50.0% 3/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	16.7% 1/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	40.0% 2/5 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	25.0% 1/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	100.0% 4/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	100.0% 4/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	100.0% 3/3 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.
Nervous system disorders Paraesthesia	0.00% 0/11 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/7 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	12.5% 1/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	12.5% 1/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	16.7% 1/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	60.0% 3/5 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	25.0% 1/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	25.0% 1/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	25.0% 1/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	66.7% 2/3 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.
Nervous system disorders Somnolence	0.00% 0/11 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	14.3% 1/7 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	12.5% 1/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/5 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/3 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.
Nervous system disorders Tremor	0.00% 0/11 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	14.3% 1/7 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/5 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/3 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.
Renal and urinary disorders Pollakiuria	0.00% 0/11 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/7 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	12.5% 1/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/5 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/3 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/11 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/7 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	20.0% 1/5 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/3 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/11 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/7 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	12.5% 1/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/5 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/3 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/11 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/7 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	16.7% 1/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/5 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/3 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Acne	0.00% 0/11 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/7 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	12.5% 1/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/5 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/3 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/11 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/7 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	16.7% 1/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/5 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/3 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Dermatitis contact	9.1% 1/11 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/7 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	37.5% 3/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	16.7% 1/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	16.7% 1/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/5 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	25.0% 1/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/3 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.
Skin and subcutaneous tissue disorders Ecchymosis	9.1% 1/11 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/7 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/8 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/6 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/5 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/2 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/4 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.	0.00% 0/3 • From Day 1 to up to 35 days after last dose of study intervention (maximum up to 88 days for Cohort 1, 76 days for Cohort 2 and 64 days for Cohort 3) Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product.

Additional Information

Name or Official Title: Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER