Trial Outcomes & Findings for Study to Evaluate Safety and Tolerability of PF-07242813 in Healthy Participants and Participants With Atopic Dermatitis (NCT NCT04668066)

NCT ID: NCT04668066

Last Updated: 2024-06-03

Results Overview

An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or other important medical events. An AE was considered as treatment emergent if the event started during the effective duration of treatment. All events that started on or after the first dosing day up to the last dose plus the lag time were considered as TEAEs.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 121 participants
• Primary outcome timeframe: From start of study treatment on Day 1 to Day 71
• Results posted on: 2024-06-03

Participant Flow

The study was conducted in 2 parts: Part 1 was conducted in healthy adult participants and Part 2 was conducted in adult participants with moderate to severe atopic dermatitis (AD).

A total of 122 participants (57 participants in single ascending dose [SAD] cohorts, 40 in multiple ascending dose [MAD] cohorts and 25 in AD cohorts) were enrolled across 5 centers in the United States.

Participant milestones

Measure	Part 1: 0.3 mg IV SAD Healthy participants were administered a single dose of 0.3 milligrams (mg) PF-07242813 as an intravenous (IV) infusion.	Part 1: 1mg IV SAD Healthy participants were administered a single dose of 1 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 3 mg IV SAD Healthy participants were administered a single dose of 3 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 10 mg IV SAD Healthy participants were administered a single dose of 10 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 30 mg IV SAD Healthy participants were administered a single dose of 30 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 100 mg IV SAD Healthy participants were administered a single dose of 100 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 300 mg IV SAD Healthy participants were administered a single dose of 300 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD Healthy participants were administered a single dose of 1000 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD (Japanese Cohort) Healthy Japanese participants were administered a single dose of 1000 mg PF-07242813 as an IV infusion.	Part 1: 15 mg SC Q2W MAD Healthy participants were administered 15 mg PF-07242813 subcutaneously every 2 weeks (Q2W) for a total of 3 doses.	Part 1: 50 mg SC Q2W MAD Healthy participants were administered 50 mg PF-07242813 subcutaneously every 2 weeks (Q2W) for a total of 3 doses.	Part 1: 150 mg SC Q2W MAD Healthy participants were administered 150 mg PF-07242813 subcutaneously every 2 weeks (Q2W) for a total of 3 doses.	Part 1: 300 mg SC Q2W MAD Healthy participants were administered 300 mg PF-07242813 subcutaneously every 2 weeks (Q2W) for a total of 3 doses.	Part 1: 500 mg IV Q2W MAD Healthy participants were administered 500 mg PF-07242813 as IV infusion every 2 weeks (Q2W) for a total of 3 doses.	Part 1: Placebo SAD Healthy participants were administered a single dose of placebo as an IV infusion.	Part 1: Placebo SC MAD Healthy participants were administered placebo every 2 weeks (Q2W) for a total of 3 doses via the SC route.	Part 1: Placebo IV MAD Healthy participants were administered placebo every 2 weeks (Q2W) for a total of 3 doses as an IV infusion.	Part 2: 1000 mg IV AD Participants with atopic dermatitis were administered a single dose of 1000 mg PF-07242813 administered as an IV Infusion.	Part 2: Placebo IV AD Participants with atopic dermatitis were administered a single dose of placebo as an IV infusion.
Part 1: Treatment Phase STARTED	2	2	2	6	6	6	6	6	4	6	6	6	6	6	17	8	2	0	0
Part 1: Treatment Phase COMPLETED	2	2	1	6	6	6	6	6	4	6	6	4	4	6	17	6	2	0	0
Part 1: Treatment Phase NOT COMPLETED	0	0	1	0	0	0	0	0	0	0	0	2	2	0	0	2	0	0	0
Part 1: Follow-Up STARTED	2	2	1	6	6	6	6	6	4	6	6	6	6	6	17	8	2	0	0
Part 1: Follow-Up COMPLETED	2	2	1	6	6	6	6	6	4	6	6	4	4	6	17	6	2	0	0
Part 1: Follow-Up NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	2	2	0	0	2	0	0	0
Part 2: Treatment Phase STARTED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	16	9
Part 2: Treatment Phase COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	16	6
Part 2: Treatment Phase NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	3
Part 2: Follow-Up STARTED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	16	8
Part 2: Follow-Up COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	16	7
Part 2: Follow-Up NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1

Reasons for withdrawal

Measure	Part 1: 0.3 mg IV SAD Healthy participants were administered a single dose of 0.3 milligrams (mg) PF-07242813 as an intravenous (IV) infusion.	Part 1: 1mg IV SAD Healthy participants were administered a single dose of 1 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 3 mg IV SAD Healthy participants were administered a single dose of 3 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 10 mg IV SAD Healthy participants were administered a single dose of 10 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 30 mg IV SAD Healthy participants were administered a single dose of 30 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 100 mg IV SAD Healthy participants were administered a single dose of 100 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 300 mg IV SAD Healthy participants were administered a single dose of 300 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD Healthy participants were administered a single dose of 1000 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD (Japanese Cohort) Healthy Japanese participants were administered a single dose of 1000 mg PF-07242813 as an IV infusion.	Part 1: 15 mg SC Q2W MAD Healthy participants were administered 15 mg PF-07242813 subcutaneously every 2 weeks (Q2W) for a total of 3 doses.	Part 1: 50 mg SC Q2W MAD Healthy participants were administered 50 mg PF-07242813 subcutaneously every 2 weeks (Q2W) for a total of 3 doses.	Part 1: 150 mg SC Q2W MAD Healthy participants were administered 150 mg PF-07242813 subcutaneously every 2 weeks (Q2W) for a total of 3 doses.	Part 1: 300 mg SC Q2W MAD Healthy participants were administered 300 mg PF-07242813 subcutaneously every 2 weeks (Q2W) for a total of 3 doses.	Part 1: 500 mg IV Q2W MAD Healthy participants were administered 500 mg PF-07242813 as IV infusion every 2 weeks (Q2W) for a total of 3 doses.	Part 1: Placebo SAD Healthy participants were administered a single dose of placebo as an IV infusion.	Part 1: Placebo SC MAD Healthy participants were administered placebo every 2 weeks (Q2W) for a total of 3 doses via the SC route.	Part 1: Placebo IV MAD Healthy participants were administered placebo every 2 weeks (Q2W) for a total of 3 doses as an IV infusion.	Part 2: 1000 mg IV AD Participants with atopic dermatitis were administered a single dose of 1000 mg PF-07242813 administered as an IV Infusion.	Part 2: Placebo IV AD Participants with atopic dermatitis were administered a single dose of placebo as an IV infusion.
Part 1: Treatment Phase Adverse Event	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0	0	0	0
Part 1: Treatment Phase Lost to Follow-up	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Part 1: Treatment Phase Other	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Part 1: Treatment Phase Withdrawal by Subject	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	2	0	0	0
Part 1: Follow-Up Adverse Event	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Part 1: Follow-Up Other	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0	0	0	0
Part 1: Follow-Up Withdrawal by Subject	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	2	0	0	0
Part 2: Treatment Phase Withdrawal by Subject	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Part 2: Treatment Phase Lost to Follow-up	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Part 2: Treatment Phase Other	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Part 2: Follow-Up Withdrawal by Subject	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1

Baseline Characteristics

Study to Evaluate Safety and Tolerability of PF-07242813 in Healthy Participants and Participants With Atopic Dermatitis

Baseline characteristics by cohort

Measure	Part 1: 0.3 mg IV SAD n=2 Participants Healthy participants were administered a single dose of 0.3 milligrams (mg) PF-07242813 as an intravenous (IV) infusion.	Part 1: 1mg IV SAD n=2 Participants Healthy participants were administered a single dose of 1 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 3 mg IV SAD n=2 Participants Healthy participants were administered a single dose of 3 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 10 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 10 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 30 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 30 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 100 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 100 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 300 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 300 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 1000 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD (Japanese Cohort) n=4 Participants Healthy Japanese participants were administered a single dose of 1000 mg PF-07242813 as an IV infusion.	Part 1: 15 mg SC Q2W MAD n=6 Participants Healthy participants were administered 15 mg PF-07242813 subcutaneously every 2 weeks (Q2W) for a total of 3 doses.	Part 1: 50 mg SC Q2W MAD n=6 Participants Healthy participants were administered 50 mg PF-07242813 subcutaneously every 2 weeks (Q2W) for a total of 3 doses.	Part 1: 150 mg SC Q2W MAD n=6 Participants Healthy participants were administered 150 mg PF-07242813 subcutaneously every 2 weeks (Q2W) for a total of 3 doses.	Part 1: 300 mg SC Q2W MAD n=6 Participants Healthy participants were administered 300 mg PF-07242813 subcutaneously every 2 weeks (Q2W) for a total of 3 doses.	Part 1: 500 mg IV Q2W MAD n=6 Participants Healthy participants were administered 500 mg PF-07242813 as IV infusion every 2 weeks (Q2W) for a total of 3 doses.	Part 1: Placebo SAD n=17 Participants Healthy participants were administered a single dose of placebo as an IV infusion.	Part 1: Placebo SC MAD n=8 Participants Healthy participants were administered placebo every 2 weeks (Q2W) for a total of 3 doses via the SC route.	Part 1: Placebo IV MAD n=2 Participants Healthy participants were administered placebo every 2 weeks (Q2W) for a total of 3 doses as an IV infusion.	Part 2: 1000 mg IV AD n=16 Participants Participants with atopic dermatitis were administered a single dose of 1000 mg PF-07242813 administered as an IV Infusion.	Part 2: Placebo IV AD n=9 Participants Participants with atopic dermatitis were administered a single dose of placebo as an IV infusion.	Total n=122 Participants Total of all reporting groups
Age, Customized 18 to 44 Years	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants	4 Participants n=21 Participants	4 Participants n=10 Participants	4 Participants n=115 Participants	3 Participants n=6 Participants	3 Participants n=6 Participants	2 Participants n=64 Participants	3 Participants n=17 Participants	5 Participants n=21 Participants	6 Participants n=22 Participants	2 Participants n=8 Participants	8 Participants n=16 Participants	5 Participants n=135 Participants	1 Participants n=136 Participants	14 Participants n=44 Participants	9 Participants n=667 Participants	84 Participants n=7 Participants
Age, Customized 45 to 64 Years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=10 Participants	2 Participants n=115 Participants	3 Participants n=6 Participants	1 Participants n=6 Participants	4 Participants n=64 Participants	3 Participants n=17 Participants	1 Participants n=21 Participants	0 Participants n=22 Participants	4 Participants n=8 Participants	9 Participants n=16 Participants	3 Participants n=135 Participants	1 Participants n=136 Participants	2 Participants n=44 Participants	0 Participants n=667 Participants	38 Participants n=7 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=10 Participants	2 Participants n=115 Participants	1 Participants n=6 Participants	2 Participants n=6 Participants	0 Participants n=64 Participants	1 Participants n=17 Participants	2 Participants n=21 Participants	0 Participants n=22 Participants	1 Participants n=8 Participants	4 Participants n=16 Participants	2 Participants n=135 Participants	0 Participants n=136 Participants	4 Participants n=44 Participants	4 Participants n=667 Participants	28 Participants n=7 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants	5 Participants n=21 Participants	3 Participants n=10 Participants	4 Participants n=115 Participants	5 Participants n=6 Participants	2 Participants n=6 Participants	6 Participants n=64 Participants	5 Participants n=17 Participants	4 Participants n=21 Participants	6 Participants n=22 Participants	5 Participants n=8 Participants	13 Participants n=16 Participants	6 Participants n=135 Participants	2 Participants n=136 Participants	12 Participants n=44 Participants	5 Participants n=667 Participants	94 Participants n=7 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=10 Participants	3 Participants n=115 Participants	2 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=64 Participants	3 Participants n=17 Participants	1 Participants n=21 Participants	2 Participants n=22 Participants	1 Participants n=8 Participants	6 Participants n=16 Participants	1 Participants n=135 Participants	1 Participants n=136 Participants	3 Participants n=44 Participants	2 Participants n=667 Participants	36 Participants n=7 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	4 Participants n=10 Participants	3 Participants n=115 Participants	4 Participants n=6 Participants	4 Participants n=6 Participants	5 Participants n=64 Participants	3 Participants n=17 Participants	5 Participants n=21 Participants	4 Participants n=22 Participants	5 Participants n=8 Participants	11 Participants n=16 Participants	7 Participants n=135 Participants	1 Participants n=136 Participants	13 Participants n=44 Participants	7 Participants n=667 Participants	86 Participants n=7 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	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	0 Participants n=22 Participants	0 Participants n=8 Participants	0 Participants n=16 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	0 Participants n=7 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	0 Participants n=22 Participants	0 Participants n=8 Participants	0 Participants n=16 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=6 Participants	4 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	1 Participants n=21 Participants	0 Participants n=22 Participants	1 Participants n=8 Participants	3 Participants n=16 Participants	1 Participants n=135 Participants	0 Participants n=136 Participants	2 Participants n=44 Participants	3 Participants n=667 Participants	16 Participants n=7 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	0 Participants n=22 Participants	0 Participants n=8 Participants	0 Participants n=16 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	0 Participants n=7 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=10 Participants	1 Participants n=115 Participants	2 Participants n=6 Participants	0 Participants n=6 Participants	2 Participants n=64 Participants	0 Participants n=17 Participants	3 Participants n=21 Participants	3 Participants n=22 Participants	3 Participants n=8 Participants	4 Participants n=16 Participants	0 Participants n=135 Participants	1 Participants n=136 Participants	6 Participants n=44 Participants	2 Participants n=667 Participants	31 Participants n=7 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants	2 Participants n=21 Participants	4 Participants n=10 Participants	3 Participants n=115 Participants	4 Participants n=6 Participants	0 Participants n=6 Participants	4 Participants n=64 Participants	6 Participants n=17 Participants	2 Participants n=21 Participants	3 Participants n=22 Participants	2 Participants n=8 Participants	10 Participants n=16 Participants	7 Participants n=135 Participants	1 Participants n=136 Participants	6 Participants n=44 Participants	4 Participants n=667 Participants	69 Participants n=7 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	0 Participants n=22 Participants	0 Participants n=8 Participants	0 Participants n=16 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	2 Participants n=44 Participants	0 Participants n=667 Participants	6 Participants n=7 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	0 Participants n=22 Participants	0 Participants n=8 Participants	0 Participants n=16 Participants	0 Participants n=135 Participants	0 Participants n=136 Participants	0 Participants n=44 Participants	0 Participants n=667 Participants	0 Participants n=7 Participants

PRIMARY outcome

Timeframe: From start of study treatment on Day 1 to Day 71

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

An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or other important medical events. An AE was considered as treatment emergent if the event started during the effective duration of treatment. All events that started on or after the first dosing day up to the last dose plus the lag time were considered as TEAEs.

Outcome measures

Measure	Part 1: 0.3 mg IV SAD n=2 Participants Healthy participants were administered a single dose of 0.3 milligrams (mg) PF-07242813 as an intravenous (IV) infusion.	Part 1: 1mg IV SAD n=2 Participants Healthy participants were administered a single dose of 1 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 3 mg IV SAD n=2 Participants Healthy participants were administered a single dose of 3 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 10 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 10 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 30 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 30 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 100 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 100 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 300 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 300 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 1000 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD (Japanese Cohort) n=4 Participants Healthy Japanese participants were administered a single dose of 1000 mg PF-07242813 as an IV infusion.	Part 1: Placebo SAD n=17 Participants Healthy participants were administered a single dose of placebo as an IV infusion.
Part 1: SAD Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) TEAEs	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	2 Participants	1 Participants	1 Participants	2 Participants	6 Participants
Part 1: SAD Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) TESAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: From start of study treatment on Day 1 to Day 99

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

An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or other important medical events. An AE was considered as treatment emergent if the event started during the effective duration of treatment. All events that started on or after the first dosing day up to the last dose plus the lag time were considered as TEAEs.

Outcome measures

Measure	Part 1: 0.3 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 0.3 milligrams (mg) PF-07242813 as an intravenous (IV) infusion.	Part 1: 1mg IV SAD n=6 Participants Healthy participants were administered a single dose of 1 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 3 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 3 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 10 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 10 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 30 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 30 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 100 mg IV SAD n=8 Participants Healthy participants were administered a single dose of 100 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 300 mg IV SAD n=2 Participants Healthy participants were administered a single dose of 300 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD Healthy participants were administered a single dose of 1000 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD (Japanese Cohort) Healthy Japanese participants were administered a single dose of 1000 mg PF-07242813 as an IV infusion.	Part 1: Placebo SAD Healthy participants were administered a single dose of placebo as an IV infusion.
Part 1: MAD Cohorts: Number of Participants With TEAEs and TESAEs TEAEs	3 Participants	1 Participants	4 Participants	2 Participants	2 Participants	5 Participants	1 Participants	—	—	—
Part 1: MAD Cohorts: Number of Participants With TEAEs and TESAEs TESAEs	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—

PRIMARY outcome

Timeframe: From start of study treatment on Day 1 to Week 16

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

An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or other important medical events. An AE was considered as treatment emergent if the event started during the effective duration of treatment. All events that started on or after the first dosing day up to the last dose plus the lag time were considered as TEAEs.

Outcome measures

Measure	Part 1: 0.3 mg IV SAD n=16 Participants Healthy participants were administered a single dose of 0.3 milligrams (mg) PF-07242813 as an intravenous (IV) infusion.	Part 1: 1mg IV SAD n=9 Participants Healthy participants were administered a single dose of 1 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 3 mg IV SAD Healthy participants were administered a single dose of 3 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 10 mg IV SAD Healthy participants were administered a single dose of 10 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 30 mg IV SAD Healthy participants were administered a single dose of 30 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 100 mg IV SAD Healthy participants were administered a single dose of 100 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 300 mg IV SAD Healthy participants were administered a single dose of 300 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD Healthy participants were administered a single dose of 1000 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD (Japanese Cohort) Healthy Japanese participants were administered a single dose of 1000 mg PF-07242813 as an IV infusion.	Part 1: Placebo SAD Healthy participants were administered a single dose of placebo as an IV infusion.
Part 2: Number of Participants With TEAEs and TESAEs TEAEs	4 Participants	5 Participants	—	—	—	—	—	—	—	—
Part 2: Number of Participants With TEAEs and TESAEs TESAEs	0 Participants	1 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: From initiation of treatment to day 71

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

Vital signs included blood pressure, pulse rate, respiratory rate and temperature. Temperature was measured by oral, tympanic, or temporal artery method. Blood pressure and respiratory rate were measured with the participant in a supine position after 5 minutes of rest for the participant. Clinically significant findings were determined by the investigator.

Outcome measures

Measure	Part 1: 0.3 mg IV SAD n=2 Participants Healthy participants were administered a single dose of 0.3 milligrams (mg) PF-07242813 as an intravenous (IV) infusion.	Part 1: 1mg IV SAD n=2 Participants Healthy participants were administered a single dose of 1 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 3 mg IV SAD n=2 Participants Healthy participants were administered a single dose of 3 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 10 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 10 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 30 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 30 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 100 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 100 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 300 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 300 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 1000 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD (Japanese Cohort) n=4 Participants Healthy Japanese participants were administered a single dose of 1000 mg PF-07242813 as an IV infusion.	Part 1: Placebo SAD n=17 Participants Healthy participants were administered a single dose of placebo as an IV infusion.
Part 1: SAD Cohorts: Number of Participants With Clinically Significant Findings in Vital Signs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From start of study treatment on Day 1 to Day 99

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

Vital signs included blood pressure, pulse rate, respiratory rate and temperature. Temperature was measured by oral, tympanic, or temporal artery method. Blood pressure and respiratory rate were measured with the participant in a supine position after 5 minutes of rest for the participant. Clinically significant findings were determined by the investigator.

Outcome measures

Measure	Part 1: 0.3 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 0.3 milligrams (mg) PF-07242813 as an intravenous (IV) infusion.	Part 1: 1mg IV SAD n=6 Participants Healthy participants were administered a single dose of 1 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 3 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 3 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 10 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 10 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 30 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 30 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 100 mg IV SAD n=8 Participants Healthy participants were administered a single dose of 100 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 300 mg IV SAD n=2 Participants Healthy participants were administered a single dose of 300 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD Healthy participants were administered a single dose of 1000 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD (Japanese Cohort) Healthy Japanese participants were administered a single dose of 1000 mg PF-07242813 as an IV infusion.	Part 1: Placebo SAD Healthy participants were administered a single dose of placebo as an IV infusion.
Part 1: MAD Cohorts: Number of Participants With Clinically Significant Findings in Vital Signs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—

PRIMARY outcome

Timeframe: From start of study treatment on Day 1 to Week 16

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

Vital signs included blood pressure, pulse rate, respiratory rate and temperature. Temperature was measured by oral, tympanic, or temporal artery method. Blood pressure and respiratory rate were measured with the participant in a supine position after 5 minutes of rest for the participant. Clinically significant findings were determined by the investigator.

Outcome measures

Measure	Part 1: 0.3 mg IV SAD n=16 Participants Healthy participants were administered a single dose of 0.3 milligrams (mg) PF-07242813 as an intravenous (IV) infusion.	Part 1: 1mg IV SAD n=9 Participants Healthy participants were administered a single dose of 1 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 3 mg IV SAD Healthy participants were administered a single dose of 3 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 10 mg IV SAD Healthy participants were administered a single dose of 10 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 30 mg IV SAD Healthy participants were administered a single dose of 30 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 100 mg IV SAD Healthy participants were administered a single dose of 100 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 300 mg IV SAD Healthy participants were administered a single dose of 300 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD Healthy participants were administered a single dose of 1000 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD (Japanese Cohort) Healthy Japanese participants were administered a single dose of 1000 mg PF-07242813 as an IV infusion.	Part 1: Placebo SAD Healthy participants were administered a single dose of placebo as an IV infusion.
Part 2: Number of Participants With Clinically Significant Findings in Vital Signs	0 Participants	0 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (last pre-dose measurement) to Day 71

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

Pre-defined criteria for laboratory parameters were hemoglobin (HGB) (<0.8* Lower limit normal (LLN)), Erythrocyte (Ery). Mean Corpuscular (MC) Volume (<0.9* LLN), Ery MC Hemoglobin (<0.9* LLN), Ery. MC HGB Concentration (<0.9* LLN), Leukocytes (<0.6* LLN), Neutrophils (<0.8* LLN), Bilirubin (>1.5* Upper limit normal (ULN)), Aspartate Aminotransferase (>3.0* ULN), Urea Nitrogen (>1.3* ULN), Creatinine (>1.3* ULN), Urate (>1.2* ULN). Number of participants with any laboratory test abnormalities meeting pre-defined criteria was reported in this outcome measure.

Outcome measures

Measure	Part 1: 0.3 mg IV SAD n=2 Participants Healthy participants were administered a single dose of 0.3 milligrams (mg) PF-07242813 as an intravenous (IV) infusion.	Part 1: 1mg IV SAD n=2 Participants Healthy participants were administered a single dose of 1 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 3 mg IV SAD n=2 Participants Healthy participants were administered a single dose of 3 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 10 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 10 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 30 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 30 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 100 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 100 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 300 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 300 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 1000 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD (Japanese Cohort) n=4 Participants Healthy Japanese participants were administered a single dose of 1000 mg PF-07242813 as an IV infusion.	Part 1: Placebo SAD n=17 Participants Healthy participants were administered a single dose of placebo as an IV infusion.
Part 1: SAD Cohorts: Number of Participants With Laboratory Test Abnormalities	1 Participants	1 Participants	1 Participants	2 Participants	2 Participants	3 Participants	3 Participants	4 Participants	2 Participants	12 Participants

PRIMARY outcome

Timeframe: Baseline (last pre-dose measurement) to Day 99

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

Pre-defined criteria for laboratory parameters were HGB (<0.8* LLN), Ery MCV (<0.9* LLN), Ery MC Hemoglobin (<0.9* LLN), Ery. MC HGB Concentration (<0.9* LLN), Leukocytes (<0.6* LLN), Neutrophils (<0.8* LLN), Bilirubin (>1.5* ULN), Aspartate Aminotransferase (>3.0* ULN), Urea Nitrogen (>1.3* ULN), Creatinine (>1.3* ULN), Urate (>1.2* ULN). Number of participants with any laboratory test abnormalities meeting pre-defined criteria was reported in this outcome measure.

Outcome measures

Measure	Part 1: 0.3 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 0.3 milligrams (mg) PF-07242813 as an intravenous (IV) infusion.	Part 1: 1mg IV SAD n=6 Participants Healthy participants were administered a single dose of 1 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 3 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 3 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 10 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 10 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 30 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 30 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 100 mg IV SAD n=8 Participants Healthy participants were administered a single dose of 100 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 300 mg IV SAD n=2 Participants Healthy participants were administered a single dose of 300 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD Healthy participants were administered a single dose of 1000 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD (Japanese Cohort) Healthy Japanese participants were administered a single dose of 1000 mg PF-07242813 as an IV infusion.	Part 1: Placebo SAD Healthy participants were administered a single dose of placebo as an IV infusion.
Part 1: MAD Cohorts: Number of Participants With Laboratory Test Abnormalities	3 Participants	2 Participants	5 Participants	5 Participants	4 Participants	6 Participants	2 Participants	—	—	—

PRIMARY outcome

Timeframe: Baseline (last pre-dose measurement) to Week 16

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

Pre-defined criteria for laboratory parameters were HGB (<0.8* LLN), Ery MCV (<0.9* LLN), Ery MC Hemoglobin (<0.9* LLN), Ery. MC HGB Concentration (<0.9* LLN), Leukocytes (<0.6* LLN), Neutrophils (<0.8* LLN), Bilirubin (>1.5* ULN), Aspartate Aminotransferase (>3.0* ULN), Urea Nitrogen (>1.3* ULN), Creatinine (>1.3* ULN), Urate (>1.2* ULN). Number of participants with any laboratory test abnormalities meeting pre-defined criteria was reported in this outcome measure.

Outcome measures

Measure	Part 1: 0.3 mg IV SAD n=16 Participants Healthy participants were administered a single dose of 0.3 milligrams (mg) PF-07242813 as an intravenous (IV) infusion.	Part 1: 1mg IV SAD n=9 Participants Healthy participants were administered a single dose of 1 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 3 mg IV SAD Healthy participants were administered a single dose of 3 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 10 mg IV SAD Healthy participants were administered a single dose of 10 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 30 mg IV SAD Healthy participants were administered a single dose of 30 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 100 mg IV SAD Healthy participants were administered a single dose of 100 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 300 mg IV SAD Healthy participants were administered a single dose of 300 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD Healthy participants were administered a single dose of 1000 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD (Japanese Cohort) Healthy Japanese participants were administered a single dose of 1000 mg PF-07242813 as an IV infusion.	Part 1: Placebo SAD Healthy participants were administered a single dose of placebo as an IV infusion.
Part 2: Number of Participants With Laboratory Test Abnormalities	11 Participants	9 Participants	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: From pre-dose up to 6 hours post dose on Day 1

Population: Safety analysis set consisted of all participants randomly assigned to study intervention and who received at least one dose of study intervention. This outcome was planned to be analyzed for SAD cohorts only as pre-specified in protocol.

Cardiac telemetry was collected in Part 1 SAD cohorts only. Number of participants with any cardiac telemetry abnormalities were reported in this outcome measure.

Outcome measures

Measure	Part 1: 0.3 mg IV SAD n=2 Participants Healthy participants were administered a single dose of 0.3 milligrams (mg) PF-07242813 as an intravenous (IV) infusion.	Part 1: 1mg IV SAD n=2 Participants Healthy participants were administered a single dose of 1 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 3 mg IV SAD n=2 Participants Healthy participants were administered a single dose of 3 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 10 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 10 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 30 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 30 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 100 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 100 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 300 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 300 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 1000 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD (Japanese Cohort) n=4 Participants Healthy Japanese participants were administered a single dose of 1000 mg PF-07242813 as an IV infusion.	Part 1: Placebo SAD n=17 Participants Healthy participants were administered a single dose of placebo as an IV infusion.
Part 1: SAD Cohorts Only: Number of Participants With Cardiac Telemetry Abnormalities	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From pre-dose on Day 1 up to Day 71

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

Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, corrected QT (QTc) intervals and QRS complex. ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. Clinically significant findings were determined by the investigator.

Outcome measures

Measure	Part 1: 0.3 mg IV SAD n=2 Participants Healthy participants were administered a single dose of 0.3 milligrams (mg) PF-07242813 as an intravenous (IV) infusion.	Part 1: 1mg IV SAD n=2 Participants Healthy participants were administered a single dose of 1 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 3 mg IV SAD n=2 Participants Healthy participants were administered a single dose of 3 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 10 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 10 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 30 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 30 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 100 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 100 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 300 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 300 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 1000 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD (Japanese Cohort) n=4 Participants Healthy Japanese participants were administered a single dose of 1000 mg PF-07242813 as an IV infusion.	Part 1: Placebo SAD n=17 Participants Healthy participants were administered a single dose of placebo as an IV infusion.
Part 1: SAD Cohorts: Number of Participants With Clinically Significant Findings in Electrocardiogram (ECG)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From pre-dose on Day 1 up to Day 99

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

Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, QTc intervals and QRS complex. ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. Clinically significant findings were determined by the investigator.

Outcome measures

Measure	Part 1: 0.3 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 0.3 milligrams (mg) PF-07242813 as an intravenous (IV) infusion.	Part 1: 1mg IV SAD n=6 Participants Healthy participants were administered a single dose of 1 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 3 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 3 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 10 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 10 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 30 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 30 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 100 mg IV SAD n=8 Participants Healthy participants were administered a single dose of 100 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 300 mg IV SAD n=2 Participants Healthy participants were administered a single dose of 300 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD Healthy participants were administered a single dose of 1000 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD (Japanese Cohort) Healthy Japanese participants were administered a single dose of 1000 mg PF-07242813 as an IV infusion.	Part 1: Placebo SAD Healthy participants were administered a single dose of placebo as an IV infusion.
Part 1: MAD Cohorts: Number of Participants With Clinically Significant Findings in ECG	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—

PRIMARY outcome

Timeframe: From pre-dose on week 1 to week 16

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

Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, QTc intervals and QRS complex. ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. Clinically significant findings were determined by the investigator.

Outcome measures

Measure	Part 1: 0.3 mg IV SAD n=16 Participants Healthy participants were administered a single dose of 0.3 milligrams (mg) PF-07242813 as an intravenous (IV) infusion.	Part 1: 1mg IV SAD n=9 Participants Healthy participants were administered a single dose of 1 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 3 mg IV SAD Healthy participants were administered a single dose of 3 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 10 mg IV SAD Healthy participants were administered a single dose of 10 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 30 mg IV SAD Healthy participants were administered a single dose of 30 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 100 mg IV SAD Healthy participants were administered a single dose of 100 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 300 mg IV SAD Healthy participants were administered a single dose of 300 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD Healthy participants were administered a single dose of 1000 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD (Japanese Cohort) Healthy Japanese participants were administered a single dose of 1000 mg PF-07242813 as an IV infusion.	Part 1: Placebo SAD Healthy participants were administered a single dose of placebo as an IV infusion.
Part 2: Number of Participants With Clinically Significant Findings in ECG	0 Participants	0 Participants	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 2, 6, 12, 24, 48, 72, 96, 336, 672 hours post-dose (for all cohorts); 1008 hours post-dose for all cohorts except 0.3 mg IV; 1344 and 1680 hours post-dose for all cohorts except 0.3 mg IV and 1 mg IV

Population: The PK parameter set consisted of all randomized participants who received at least 1 dose of study intervention and who have at least 1 of the PK parameters of interest calculated. Data was not summarized for PK parameters if less than 3 participants had evaluable data values as pre-specified in the statistical analysis plan; hence, individual values were reported for 0.3 mg IV SAD, 1 mg IV SAD and 3 mg IV SAD cohorts.

AUClast was calculated using the linear/log trapezoidal method.

Outcome measures

Measure	Part 1: 0.3 mg IV SAD n=2 Participants Healthy participants were administered a single dose of 0.3 milligrams (mg) PF-07242813 as an intravenous (IV) infusion.	Part 1: 1mg IV SAD n=2 Participants Healthy participants were administered a single dose of 1 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 3 mg IV SAD n=2 Participants Healthy participants were administered a single dose of 3 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 10 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 10 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 30 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 30 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 100 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 100 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 300 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 300 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 1000 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD (Japanese Cohort) n=4 Participants Healthy Japanese participants were administered a single dose of 1000 mg PF-07242813 as an IV infusion.	Part 1: Placebo SAD Healthy participants were administered a single dose of placebo as an IV infusion.
Part 1: SAD Cohorts: Area Under the Serum Concentration Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) for PF-07242813	NA Nanogram*hour/milliliter Geometric Coefficient of Variation NA Data for this cohort was not summarized per plan. Individual values for participants were 2390 and 3710.	NA Nanogram*hour/milliliter Geometric Coefficient of Variation NA Data for this cohort was not summarized per plan. Individual values for participants were 14700 and 17500.	NA Nanogram*hour/milliliter Geometric Coefficient of Variation NA Data for this cohort was not summarized per plan. Individual values for participants were 55100 and 80800.	546200 Nanogram*hour/milliliter Geometric Coefficient of Variation 29	1834000 Nanogram*hour/milliliter Geometric Coefficient of Variation 22	9349000 Nanogram*hour/milliliter Geometric Coefficient of Variation 23	38990000 Nanogram*hour/milliliter Geometric Coefficient of Variation 31	133800000 Nanogram*hour/milliliter Geometric Coefficient of Variation 17	155900000 Nanogram*hour/milliliter Geometric Coefficient of Variation 17	—

SECONDARY outcome

Timeframe: Pre-dose, 2, 6, 12, 24, 48, 72, 96, 336, 672 hours post-dose (for all cohorts); 1008 hours post-dose for all cohorts except 0.3 mg IV; 1344 and 1680 hours post-dose for all cohorts except 0.3 mg IV and 1 mg IV

Population: The PK parameter set consisted of all randomized participants who received at least 1 dose of study intervention and who have at least 1 of the PK parameters of interest calculated. Here, 'Overall Number of Participants Analyzed' signifies number of participants with evaluable results for this outcome measure. Data was not summarized for PK parameters if less than 3 participants had evaluable data values as pre-specified in the statistical analysis plan.

AUCinf was determined as AUClast + (Clast divided by kel), where Clast = predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel= terminal phase rate constant.

Outcome measures

Measure	Part 1: 0.3 mg IV SAD Healthy participants were administered a single dose of 0.3 milligrams (mg) PF-07242813 as an intravenous (IV) infusion.	Part 1: 1mg IV SAD Healthy participants were administered a single dose of 1 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 3 mg IV SAD n=1 Participants Healthy participants were administered a single dose of 3 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 10 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 10 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 30 mg IV SAD n=5 Participants Healthy participants were administered a single dose of 30 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 100 mg IV SAD n=4 Participants Healthy participants were administered a single dose of 100 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 300 mg IV SAD n=5 Participants Healthy participants were administered a single dose of 300 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 1000 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD (Japanese Cohort) n=4 Participants Healthy Japanese participants were administered a single dose of 1000 mg PF-07242813 as an IV infusion.	Part 1: Placebo SAD Healthy participants were administered a single dose of placebo as an IV infusion.
Part 1: SAD Cohorts: Area Under the Serum Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) for PF-07242813	—	—	92700 Nanogram*hour/milliliter Geometric Coefficient of Variation NA Data for this cohort was not summarized per plan. Individual value for participants was 92700.	555100 Nanogram*hour/milliliter Geometric Coefficient of Variation 28	1912000 Nanogram*hour/milliliter Geometric Coefficient of Variation 24	9790000 Nanogram*hour/milliliter Geometric Coefficient of Variation 27	46510000 Nanogram*hour/milliliter Geometric Coefficient of Variation 19	153700000 Nanogram*hour/milliliter Geometric Coefficient of Variation 21	173700000 Nanogram*hour/milliliter Geometric Coefficient of Variation 20	—

SECONDARY outcome

Timeframe: Pre-dose, 2, 6, 12, 24, 48, 72, 96, 336, 672 hours post-dose (for all cohorts); 1008 hours post-dose for all cohorts except 0.3 mg IV; 1344 and 1680 hours post-dose for all cohorts except 0.3 mg IV and 1 mg IV

Population: The PK parameter set consisted of all randomized participants who received at least 1 dose of study intervention and who have at least 1 of the PK parameters of interest calculated. Data was not summarized for PK parameters if less than 3 participants had evaluable data values as pre-specified in the statistical analysis plan; hence, individual values were reported for 0.3 mg IV SAD, 1 mg IV SAD and 3 mg IV SAD cohorts.

Outcome measures

Measure	Part 1: 0.3 mg IV SAD n=2 Participants Healthy participants were administered a single dose of 0.3 milligrams (mg) PF-07242813 as an intravenous (IV) infusion.	Part 1: 1mg IV SAD n=2 Participants Healthy participants were administered a single dose of 1 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 3 mg IV SAD n=2 Participants Healthy participants were administered a single dose of 3 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 10 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 10 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 30 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 30 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 100 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 100 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 300 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 300 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 1000 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD (Japanese Cohort) n=4 Participants Healthy Japanese participants were administered a single dose of 1000 mg PF-07242813 as an IV infusion.	Part 1: Placebo SAD Healthy participants were administered a single dose of placebo as an IV infusion.
Part 1: SAD Cohorts: Maximum Serum Concentration (Cmax) for PF-07242813	NA Nanogram per milliliter Geometric Coefficient of Variation NA Data for this cohort was not summarized per plan. Individual values for participants were 38.8 and 67.9.	NA Nanogram per milliliter Geometric Coefficient of Variation NA Data for this cohort was not summarized per plan. Individual values for participants were 241 and 304.	NA Nanogram per milliliter Geometric Coefficient of Variation NA Data for this cohort was not summarized per plan. Individual values for participants were 801 and 842.	3271 Nanogram per milliliter Geometric Coefficient of Variation 23	8397 Nanogram per milliliter Geometric Coefficient of Variation 48	33250 Nanogram per milliliter Geometric Coefficient of Variation 34	110200 Nanogram per milliliter Geometric Coefficient of Variation 24	362000 Nanogram per milliliter Geometric Coefficient of Variation 11	445900 Nanogram per milliliter Geometric Coefficient of Variation 10	—

SECONDARY outcome

Timeframe: Pre-dose, 2, 6, 12, 24, 48, 72, 96, 336, 672 hours post-dose (for all cohorts); 1008 hours post-dose for all cohorts except 0.3 mg IV; 1344 and 1680 hours post-dose for all cohorts except 0.3 mg IV and 1 mg IV

Population: The PK parameter set consisted of all randomized participants who received at least 1 dose of study intervention and who have at least 1 of the PK parameters of interest calculated. Data was not summarized for PK parameters if less than 3 participants had evaluable data values as pre-specified in the statistical analysis plan; hence, individual values were reported for 0.3 mg IV SAD, 1 mg IV SAD and 3 mg IV SAD cohorts.

Outcome measures

Measure	Part 1: 0.3 mg IV SAD n=2 Participants Healthy participants were administered a single dose of 0.3 milligrams (mg) PF-07242813 as an intravenous (IV) infusion.	Part 1: 1mg IV SAD n=2 Participants Healthy participants were administered a single dose of 1 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 3 mg IV SAD n=2 Participants Healthy participants were administered a single dose of 3 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 10 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 10 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 30 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 30 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 100 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 100 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 300 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 300 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 1000 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD (Japanese Cohort) n=4 Participants Healthy Japanese participants were administered a single dose of 1000 mg PF-07242813 as an IV infusion.	Part 1: Placebo SAD Healthy participants were administered a single dose of placebo as an IV infusion.
Part 1: SAD Cohorts: Time to Reach Maximum Concentration (Tmax) for PF-07242813	NA Hours Data for this cohort was not summarized per plan. Individual values for participants were 2 and 12.	NA Hours Data for this cohort was not summarized per plan. Individual values for participants were 0.6 and 2.	NA Hours Data for this cohort was not summarized per plan. Individual values for participants were 0.617 and 2.	2.00 Hours Interval 0.6 to 2.0	2.00 Hours Interval 0.6 to 72.0	1.61 Hours Interval 1.22 to 12.0	2.00 Hours Interval 1.22 to 2.0	2.00 Hours Interval 1.22 to 12.0	1.22 Hours Interval 1.22 to 1.22	—

SECONDARY outcome

Timeframe: Pre-dose, 2, 6, 12, 24, 48, 72, 96, 336, 672 hours post-dose (for all cohorts); 1008 hours post-dose for all cohorts except 0.3 mg IV; 1344 and 1680 hours post-dose for all cohorts except 0.3 mg IV and 1 mg IV

Population: The PK parameter set consisted of all randomized participants who received at least 1 dose of study intervention and who have at least 1 of the PK parameters of interest calculated. Here, 'Overall Number of Participants Analyzed' signifies number of participants with evaluable results for this outcome measure. Data was not summarized for PK parameters if less than 3 participants had evaluable data values as pre-specified in the statistical analysis plan.

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

Outcome measures

Measure	Part 1: 0.3 mg IV SAD Healthy participants were administered a single dose of 0.3 milligrams (mg) PF-07242813 as an intravenous (IV) infusion.	Part 1: 1mg IV SAD Healthy participants were administered a single dose of 1 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 3 mg IV SAD n=1 Participants Healthy participants were administered a single dose of 3 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 10 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 10 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 30 mg IV SAD n=5 Participants Healthy participants were administered a single dose of 30 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 100 mg IV SAD n=4 Participants Healthy participants were administered a single dose of 100 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 300 mg IV SAD n=5 Participants Healthy participants were administered a single dose of 300 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 1000 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD (Japanese Cohort) n=4 Participants Healthy Japanese participants were administered a single dose of 1000 mg PF-07242813 as an IV infusion.	Part 1: Placebo SAD Healthy participants were administered a single dose of placebo as an IV infusion.
Part 1: SAD Cohorts: Terminal Elimination Half Life (t1/2) for PF-07242813	—	—	NA Hours Geometric Coefficient of Variation NA Data for this cohort was not summarized per plan. Individual value for participants was 107.	138.0 Hours Geometric Coefficient of Variation 38.152	170.8 Hours Geometric Coefficient of Variation 46.300	256.0 Hours Geometric Coefficient of Variation 65.396	434.6 Hours Geometric Coefficient of Variation 50.708	557.8 Hours Geometric Coefficient of Variation 118.48	545.5 Hours Geometric Coefficient of Variation 80.707	—

SECONDARY outcome

Timeframe: Day 1,15,29(Pre-dose,2,6,12,24,48,72,96 hours post-dose) Day 15,29(168hours post-dose) Day 29(336hours post-dose) (For all cohorts); Day 1(168hours post-dose for all except 15mg and 50 mg post-dose)

Population: The PK parameter set consisted of all randomized participants who received at least 1 dose of study intervention and who have at least 1 of the PK parameters of interest calculated. Here, 'Number Analyzed' signifies number of participants evaluable for the specified timepoints.

Area under the serum concentration time- profile over the dosing interval tau where tau=2 weeks (336 hours).

Outcome measures

Measure	Part 1: 0.3 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 0.3 milligrams (mg) PF-07242813 as an intravenous (IV) infusion.	Part 1: 1mg IV SAD n=6 Participants Healthy participants were administered a single dose of 1 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 3 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 3 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 10 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 10 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 30 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 30 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 100 mg IV SAD Healthy participants were administered a single dose of 100 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 300 mg IV SAD Healthy participants were administered a single dose of 300 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD Healthy participants were administered a single dose of 1000 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD (Japanese Cohort) Healthy Japanese participants were administered a single dose of 1000 mg PF-07242813 as an IV infusion.	Part 1: Placebo SAD Healthy participants were administered a single dose of placebo as an IV infusion.
Part 1: MAD Cohorts: Area Under the Serum Concentration Time Profile Over the Dosing Interval (AUCtau) for PF-07242813 Day 1	296000 Nanogram*hour/milliliter Standard Deviation 47	981600 Nanogram*hour/milliliter Standard Deviation 46	5543000 Nanogram*hour/milliliter Standard Deviation 23	12560000 Nanogram*hour/milliliter Standard Deviation 36	27290000 Nanogram*hour/milliliter Standard Deviation 24	—	—	—	—	—
Part 1: MAD Cohorts: Area Under the Serum Concentration Time Profile Over the Dosing Interval (AUCtau) for PF-07242813 Day 15	503400 Nanogram*hour/milliliter Standard Deviation 39	2294000 Nanogram*hour/milliliter Standard Deviation 37	10160000 Nanogram*hour/milliliter Standard Deviation 4	19190000 Nanogram*hour/milliliter Standard Deviation 20	50040000 Nanogram*hour/milliliter Standard Deviation 28	—	—	—	—	—
Part 1: MAD Cohorts: Area Under the Serum Concentration Time Profile Over the Dosing Interval (AUCtau) for PF-07242813 Day 29	615300 Nanogram*hour/milliliter Standard Deviation 39	3172000 Nanogram*hour/milliliter Standard Deviation 32	11880000 Nanogram*hour/milliliter Standard Deviation 14	24500000 Nanogram*hour/milliliter Standard Deviation 13	68840000 Nanogram*hour/milliliter Standard Deviation 27	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1,15,29(Pre-dose,2,6,12,24,48,72,96 hours post-dose) Day 15,29(168hours post-dose) Day 29(336,672,1008,1344,1680hours post-dose) (For all cohorts); Day 1(168hours post-dose for all except 15mg and 50 mg post-dose)

Population: The PK parameter set consisted of all randomized participants who received at least 1 dose of study intervention and who have at least 1 of the PK parameters of interest calculated. Here, 'Number Analyzed' signifies number of participants evaluable for the specified timepoints.

Outcome measures

Measure	Part 1: 0.3 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 0.3 milligrams (mg) PF-07242813 as an intravenous (IV) infusion.	Part 1: 1mg IV SAD n=6 Participants Healthy participants were administered a single dose of 1 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 3 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 3 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 10 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 10 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 30 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 30 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 100 mg IV SAD Healthy participants were administered a single dose of 100 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 300 mg IV SAD Healthy participants were administered a single dose of 300 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD Healthy participants were administered a single dose of 1000 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD (Japanese Cohort) Healthy Japanese participants were administered a single dose of 1000 mg PF-07242813 as an IV infusion.	Part 1: Placebo SAD Healthy participants were administered a single dose of placebo as an IV infusion.
Part 1: MAD Cohorts: Cmax for PF-07242813 Day 1	1087 Nanogram per milliliter Geometric Coefficient of Variation 43	3619 Nanogram per milliliter Geometric Coefficient of Variation 39	21380 Nanogram per milliliter Geometric Coefficient of Variation 13	48550 Nanogram per milliliter Geometric Coefficient of Variation 36	163800 Nanogram per milliliter Geometric Coefficient of Variation 18	—	—	—	—	—
Part 1: MAD Cohorts: Cmax for PF-07242813 Day 15	1828 Nanogram per milliliter Geometric Coefficient of Variation 33	8052 Nanogram per milliliter Geometric Coefficient of Variation 38	39470 Nanogram per milliliter Geometric Coefficient of Variation 19	76130 Nanogram per milliliter Geometric Coefficient of Variation 40	266100 Nanogram per milliliter Geometric Coefficient of Variation 32	—	—	—	—	—
Part 1: MAD Cohorts: Cmax for PF-07242813 Day 29	1778 Nanogram per milliliter Geometric Coefficient of Variation 75	10470 Nanogram per milliliter Geometric Coefficient of Variation 33	41080 Nanogram per milliliter Geometric Coefficient of Variation 19	83590 Nanogram per milliliter Geometric Coefficient of Variation 16	332900 Nanogram per milliliter Geometric Coefficient of Variation 20	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1,15,29(Pre-dose,2,6,12,24,48,72,96 hours post-dose) Day 15,29(168hours post-dose) Day 29(336,672,1008,1344,1680hours post-dose) (For all cohorts); Day 1(168hours post-dose for all except 15mg and 50 mg post-dose)

Population: The PK parameter set consisted of all randomized participants who received at least 1 dose of study intervention and who have at least 1 of the PK parameters of interest calculated. Here, 'Number Analyzed' signifies number of participants evaluable for the specified timepoints.

Outcome measures

Measure	Part 1: 0.3 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 0.3 milligrams (mg) PF-07242813 as an intravenous (IV) infusion.	Part 1: 1mg IV SAD n=6 Participants Healthy participants were administered a single dose of 1 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 3 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 3 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 10 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 10 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 30 mg IV SAD n=6 Participants Healthy participants were administered a single dose of 30 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 100 mg IV SAD Healthy participants were administered a single dose of 100 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 300 mg IV SAD Healthy participants were administered a single dose of 300 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD Healthy participants were administered a single dose of 1000 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD (Japanese Cohort) Healthy Japanese participants were administered a single dose of 1000 mg PF-07242813 as an IV infusion.	Part 1: Placebo SAD Healthy participants were administered a single dose of placebo as an IV infusion.
Part 1: MAD Cohorts: Tmax for PF-07242813 Day 1	96.00 Hours Interval 96.0 to 336.0	216.05 Hours Interval 72.0 to 336.0	96.00 Hours Interval 72.0 to 146.0	72.00 Hours Interval 23.8 to 167.0	1.61 Hours Interval 1.22 to 2.0	—	—	—	—	—
Part 1: MAD Cohorts: Tmax for PF-07242813 Day 15	168.00 Hours Interval 48.0 to 216.0	156.00 Hours Interval 144.0 to 336.0	96.20 Hours Interval 23.9 to 143.0	48.00 Hours Interval 48.0 to 169.0	2.00 Hours Interval 1.22 to 2.0	—	—	—	—	—
Part 1: MAD Cohorts: Tmax for PF-07242813 Day 29	168.50 Hours Interval 48.0 to 171.0	157.50 Hours Interval 146.0 to 312.0	135.00 Hours Interval 48.0 to 170.0	72.60 Hours Interval 23.8 to 148.0	4.00 Hours Interval 2.0 to 23.8	—	—	—	—	—

SECONDARY outcome

Timeframe: Day 1,15,29(Pre-dose,2,6,12,24,48,72,96 hours post-dose) Day 15,29(168hours post-dose) Day 29(336,672,1008,1344,1680hours post-dose) (For all cohorts); Day 1(168hours post-dose for all except 15mg and 50 mg post-dose)

Population: The PK parameter set consisted of all randomized participants who received at least 1 dose of study intervention and who have at least 1 of the PK parameters of interest calculated. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified time points.

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

Outcome measures

Measure	Part 1: 0.3 mg IV SAD n=2 Participants Healthy participants were administered a single dose of 0.3 milligrams (mg) PF-07242813 as an intravenous (IV) infusion.	Part 1: 1mg IV SAD n=6 Participants Healthy participants were administered a single dose of 1 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 3 mg IV SAD n=4 Participants Healthy participants were administered a single dose of 3 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 10 mg IV SAD n=4 Participants Healthy participants were administered a single dose of 10 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 30 mg IV SAD n=4 Participants Healthy participants were administered a single dose of 30 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 100 mg IV SAD Healthy participants were administered a single dose of 100 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 300 mg IV SAD Healthy participants were administered a single dose of 300 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD Healthy participants were administered a single dose of 1000 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD (Japanese Cohort) Healthy Japanese participants were administered a single dose of 1000 mg PF-07242813 as an IV infusion.	Part 1: Placebo SAD Healthy participants were administered a single dose of placebo as an IV infusion.
Part 1: MAD Cohorts: Terminal Elimination Half Life (t1/2) for PF-07242813 Day 29	111 Hours Standard Deviation 190	210.5 Hours Standard Deviation 82.674	352.8 Hours Standard Deviation 99.704	475.5 Hours Standard Deviation 140.58	474.0 Hours Standard Deviation 98.346	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 6

Population: Modified Intention to Treat (mITT) population consisted of all randomized participants assigned to study intervention and who applied at least 1 dose of study intervention. One participant was randomized twice under different participant ID (PID) at two different sites. The participant was included in the efficacy analyses under the first PID. The participant enrolled under the second PID was included in mITT per mITT definition, but was excluded from efficacy analysis.

EASI quantifies severity of AD based on severity of lesion clinical signs and percentage (%) of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema, induration/papulation, excoriation and lichenification) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin)] and lower limbs [including buttocks]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, with higher scores indicating greater severity of AD.

Outcome measures

Measure	Part 1: 0.3 mg IV SAD n=15 Participants Healthy participants were administered a single dose of 0.3 milligrams (mg) PF-07242813 as an intravenous (IV) infusion.	Part 1: 1mg IV SAD n=9 Participants Healthy participants were administered a single dose of 1 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 3 mg IV SAD Healthy participants were administered a single dose of 3 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 10 mg IV SAD Healthy participants were administered a single dose of 10 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 30 mg IV SAD Healthy participants were administered a single dose of 30 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 100 mg IV SAD Healthy participants were administered a single dose of 100 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 300 mg IV SAD Healthy participants were administered a single dose of 300 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD Healthy participants were administered a single dose of 1000 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD (Japanese Cohort) Healthy Japanese participants were administered a single dose of 1000 mg PF-07242813 as an IV infusion.	Part 1: Placebo SAD Healthy participants were administered a single dose of placebo as an IV infusion.
Part 2: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6	-38.2 Percent change Interval -54.2 to -22.2	-43.8 Percent change Interval -65.3 to -22.3	—	—	—	—	—	—	—	—

Adverse Events

Part 1: 0.3 mg IV SAD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 1: 1mg IV SAD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 1: 3 mg IV SAD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 1: 10 mg IV SAD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 1: 30 mg IV SAD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 1: 100 mg IV SAD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 1: 300 mg IV SAD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 1: 1000 mg IV SAD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 1: 1000 mg IV SAD (Japanese Cohort)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 1: 15 mg SC Q2W MAD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 1: 50 mg SC Q2W MAD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 1: 150 mg SC Q2W MAD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 1: 300 mg SC Q2W MAD

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 1: 500 mg IV Q2W MAD

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 1: Placebo SAD

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 1: Placebo SC MAD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 1: Placebo IV MAD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part 2: 1000 mg IV AD

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 2: Placebo IV AD

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Part 1: 0.3 mg IV SAD n=2 participants at risk Healthy participants were administered a single dose of 0.3 milligrams (mg) PF-07242813 as an intravenous (IV) infusion.	Part 1: 1mg IV SAD n=2 participants at risk Healthy participants were administered a single dose of 1 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 3 mg IV SAD n=2 participants at risk Healthy participants were administered a single dose of 3 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 10 mg IV SAD n=6 participants at risk Healthy participants were administered a single dose of 10 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 30 mg IV SAD n=6 participants at risk Healthy participants were administered a single dose of 30 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 100 mg IV SAD n=6 participants at risk Healthy participants were administered a single dose of 100 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 300 mg IV SAD n=6 participants at risk Healthy participants were administered a single dose of 300 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD n=6 participants at risk Healthy participants were administered a single dose of 1000 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD (Japanese Cohort) n=4 participants at risk Healthy Japanese participants were administered a single dose of 1000 mg PF-07242813 as an IV infusion.	Part 1: 15 mg SC Q2W MAD n=6 participants at risk Healthy participants were administered 15 mg PF-07242813 subcutaneously every 2 weeks (Q2W) for a total of 3 doses.	Part 1: 50 mg SC Q2W MAD n=6 participants at risk Healthy participants were administered 50 mg PF-07242813 subcutaneously every 2 weeks (Q2W) for a total of 3 doses.	Part 1: 150 mg SC Q2W MAD n=6 participants at risk Healthy participants were administered 150 mg PF-07242813 subcutaneously every 2 weeks (Q2W) for a total of 3 doses.	Part 1: 300 mg SC Q2W MAD n=6 participants at risk Healthy participants were administered 300 mg PF-07242813 subcutaneously every 2 weeks (Q2W) for a total of 3 doses.	Part 1: 500 mg IV Q2W MAD n=6 participants at risk Healthy participants were administered 500 mg PF-07242813 as IV infusion every 2 weeks (Q2W) for a total of 3 doses.	Part 1: Placebo SAD n=17 participants at risk Healthy participants were administered a single dose of placebo as an IV infusion.	Part 1: Placebo SC MAD n=8 participants at risk Healthy participants were administered placebo every 2 weeks (Q2W) for a total of 3 doses via the SC route.	Part 1: Placebo IV MAD n=2 participants at risk Healthy participants were administered placebo every 2 weeks (Q2W) for a total of 3 doses as an IV infusion.	Part 2: 1000 mg IV AD n=16 participants at risk Participants with atopic dermatitis were administered a single dose of 1000 mg PF-07242813 administered as an IV Infusion.	Part 2: Placebo IV AD n=9 participants at risk Participants with atopic dermatitis were administered a single dose of placebo as an IV infusion.
Immune system disorders Anaphylactic reaction	0.00% 0/2 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/2 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/2 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/4 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/17 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/8 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/2 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/16 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	11.1% 1/9 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.
Infections and infestations Pneumonia	0.00% 0/2 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/2 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/2 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/4 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	16.7% 1/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/17 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/8 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/2 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/16 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/9 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/2 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/2 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/2 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/4 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	16.7% 1/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/17 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/8 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/2 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/16 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/9 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.
Investigations SARS-CoV-2 test positive	0.00% 0/2 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/2 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/2 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/4 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	5.9% 1/17 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/8 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/2 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/16 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/9 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.

Other adverse events

Measure	Part 1: 0.3 mg IV SAD n=2 participants at risk Healthy participants were administered a single dose of 0.3 milligrams (mg) PF-07242813 as an intravenous (IV) infusion.	Part 1: 1mg IV SAD n=2 participants at risk Healthy participants were administered a single dose of 1 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 3 mg IV SAD n=2 participants at risk Healthy participants were administered a single dose of 3 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 10 mg IV SAD n=6 participants at risk Healthy participants were administered a single dose of 10 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 30 mg IV SAD n=6 participants at risk Healthy participants were administered a single dose of 30 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 100 mg IV SAD n=6 participants at risk Healthy participants were administered a single dose of 100 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 300 mg IV SAD n=6 participants at risk Healthy participants were administered a single dose of 300 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD n=6 participants at risk Healthy participants were administered a single dose of 1000 mg PF-07242813 as an intravenous (IV) infusion.	Part 1: 1000 mg IV SAD (Japanese Cohort) n=4 participants at risk Healthy Japanese participants were administered a single dose of 1000 mg PF-07242813 as an IV infusion.	Part 1: 15 mg SC Q2W MAD n=6 participants at risk Healthy participants were administered 15 mg PF-07242813 subcutaneously every 2 weeks (Q2W) for a total of 3 doses.	Part 1: 50 mg SC Q2W MAD n=6 participants at risk Healthy participants were administered 50 mg PF-07242813 subcutaneously every 2 weeks (Q2W) for a total of 3 doses.	Part 1: 150 mg SC Q2W MAD n=6 participants at risk Healthy participants were administered 150 mg PF-07242813 subcutaneously every 2 weeks (Q2W) for a total of 3 doses.	Part 1: 300 mg SC Q2W MAD n=6 participants at risk Healthy participants were administered 300 mg PF-07242813 subcutaneously every 2 weeks (Q2W) for a total of 3 doses.	Part 1: 500 mg IV Q2W MAD n=6 participants at risk Healthy participants were administered 500 mg PF-07242813 as IV infusion every 2 weeks (Q2W) for a total of 3 doses.	Part 1: Placebo SAD n=17 participants at risk Healthy participants were administered a single dose of placebo as an IV infusion.	Part 1: Placebo SC MAD n=8 participants at risk Healthy participants were administered placebo every 2 weeks (Q2W) for a total of 3 doses via the SC route.	Part 1: Placebo IV MAD n=2 participants at risk Healthy participants were administered placebo every 2 weeks (Q2W) for a total of 3 doses as an IV infusion.	Part 2: 1000 mg IV AD n=16 participants at risk Participants with atopic dermatitis were administered a single dose of 1000 mg PF-07242813 administered as an IV Infusion.	Part 2: Placebo IV AD n=9 participants at risk Participants with atopic dermatitis were administered a single dose of placebo as an IV infusion.
Investigations Alanine aminotransferase increased	0.00% 0/2 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/2 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/2 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/4 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/17 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/8 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/2 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	6.2% 1/16 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/9 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.
Investigations Aspartate aminotransferase increased	0.00% 0/2 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/2 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/2 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/4 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	16.7% 1/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/17 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/8 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/2 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/16 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/9 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/2 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/2 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/2 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/4 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	16.7% 1/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/17 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/8 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/2 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/16 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/9 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/2 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/2 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/2 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	25.0% 1/4 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/17 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/8 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/2 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/16 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/9 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/2 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/2 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/2 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/4 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/6 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/17 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/8 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/2 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	0.00% 0/16 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.	11.1% 1/9 • For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16). An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.

Additional Information

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Phone: 1-800-718-1021

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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 publications 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