Trial Outcomes & Findings for First-In-Human Study To Evaluate Safety, Tolerability, And Pharmacokinetics Following Single Ascending And Multiple Ascending Doses of PF-07304814 In Hospitalized Participants With COVID-19. (NCT NCT04535167)

NCT ID: NCT04535167

Last Updated: 2023-05-03

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. A serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. An adverse event was considered a Treatment-Emergent Adverse Event (TEAE) if the event started during the effective duration of treatment.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 26 participants
• Primary outcome timeframe: Day 1 to 37 days
• Results posted on: 2023-05-03

Participant Flow

A total of 26 hospitalized participants with COVID-19 were enrolled in this study. 25 participants were randomized to receive single ascending (24-hour, part 1) or multiple ascending (120-hour, part 2) intravenous infusions of PF-07304814 or placebo. One participant was not treated and discontinued from study due to being incorrectly randomized. All reported data are on 25 participants who were randomized and received at least 1 dose of PF-07304814 or placebo (referred to as "enrolled" herein).

Participant milestones

Measure	Part 1: PF-07304814 500 mg 24-hours Continuous Infusion Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion.	Part 1: PF-07304814 250 mg 24-hours Continuous Infusion Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion.	Part 1: 500 mg Placebo 24-hours Continuous Infusion Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.	Part 1: 250 mg Placebo 24-hours Continuous Infusion Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.	Part 2: PF-07304814 500 mg 120-hours Continuous Infusion Participants were enrolled in this arm and received PF-07304814 500 mg daily as 5-day (\~120 hours) continuous intravenous infusion.	Part 2: PF-07304814 250 mg 120-hours Continuous Infusion Participants were enrolled in this arm and received PF-07304814 250 mg daily as 5-day (\~120 hours) continuous intravenous infusion.	Part 2: Placebo 120-hours Continuous Infusion Participants were enrolled in this arm and received placebo as 5-day (\~120 hours) continuous intravenous infusion.
Treatment STARTED	2	2	2	2	6	7	4
Treatment COMPLETED	2	2	2	2	6	7	3
Treatment NOT COMPLETED	0	0	0	0	0	0	1
Follow-Up STARTED	2	2	2	2	6	7	4
Follow-Up COMPLETED	2	2	2	1	6	7	3
Follow-Up NOT COMPLETED	0	0	0	1	0	0	1

Reasons for withdrawal

Measure	Part 1: PF-07304814 500 mg 24-hours Continuous Infusion Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion.	Part 1: PF-07304814 250 mg 24-hours Continuous Infusion Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion.	Part 1: 500 mg Placebo 24-hours Continuous Infusion Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.	Part 1: 250 mg Placebo 24-hours Continuous Infusion Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.	Part 2: PF-07304814 500 mg 120-hours Continuous Infusion Participants were enrolled in this arm and received PF-07304814 500 mg daily as 5-day (\~120 hours) continuous intravenous infusion.	Part 2: PF-07304814 250 mg 120-hours Continuous Infusion Participants were enrolled in this arm and received PF-07304814 250 mg daily as 5-day (\~120 hours) continuous intravenous infusion.	Part 2: Placebo 120-hours Continuous Infusion Participants were enrolled in this arm and received placebo as 5-day (\~120 hours) continuous intravenous infusion.
Treatment Adverse Event	0	0	0	0	0	0	1
Follow-Up Death	0	0	0	0	0	0	1
Follow-Up Lost to Follow-up	0	0	0	1	0	0	0

Baseline Characteristics

First-In-Human Study To Evaluate Safety, Tolerability, And Pharmacokinetics Following Single Ascending And Multiple Ascending Doses of PF-07304814 In Hospitalized Participants With COVID-19.

Baseline characteristics by cohort

Measure	Part 1: PF-07304814 500 mg 24-hours Continuous Infusion n=2 Participants Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion.	Part 1: PF-07304814 250 mg 24-hours Continuous Infusion n=2 Participants Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion.	Part 1: 500 mg Placebo 24-hours Continuous Infusion n=2 Participants Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.	Part 1: 250 mg Placebo 24-hours Continuous Infusion n=2 Participants Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.	Part 2: PF-07304814 500 mg 120-hours Continuous Infusion n=6 Participants Participants were enrolled in this arm and received PF-07304814 500 mg daily as 5-day (\~120 hours) continuous intravenous infusion.	Part 2: PF-07304814 250 mg 120-hours Continuous Infusion n=7 Participants Participants were enrolled in this arm and received PF-07304814 250 mg daily as 5-day (\~120 hours) continuous intravenous infusion.	Part 2: Placebo 120-hours Continuous Infusion n=4 Participants Participants were enrolled in this arm and received placebo as 5-day (\~120 hours) continuous intravenous infusion.	Total n=25 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants	5 Participants n=8 Participants	2 Participants n=8 Participants	18 Participants n=24 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants	2 Participants n=8 Participants	7 Participants n=24 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	6 Participants n=24 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants	6 Participants n=8 Participants	4 Participants n=8 Participants	19 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	4 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants	5 Participants n=8 Participants	3 Participants n=8 Participants	18 Participants n=24 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	2 Participants n=8 Participants	1 Participants n=8 Participants	3 Participants n=24 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=8 Participants	0 Participants n=8 Participants	0 Participants n=24 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	1 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 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=8 Participants	0 Participants n=8 Participants	0 Participants n=24 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	1 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	2 Participants n=24 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	5 Participants n=21 Participants	5 Participants n=8 Participants	3 Participants n=8 Participants	19 Participants n=24 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	3 Participants n=24 Participants

PRIMARY outcome

Timeframe: Day 1 to 37 days

Population: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for the given part of the study (Part 1: SAD). Participants were analyzed according to the product they actually received.

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. A serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. An adverse event was considered a Treatment-Emergent Adverse Event (TEAE) if the event started during the effective duration of treatment.

Outcome measures

Measure	Part 1: PF-07304814 500 mg 24-hours Continuous Infusion n=2 Participants Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion.	Part 1: PF-07304814 250 mg 24-hours Continuous Infusion n=2 Participants Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion.	Part 1: 500 mg Placebo 24-hours Continuous Infusion n=2 Participants Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.	Part 1: 250 mg Placebo 24-hours Continuous Infusion n=2 Participants Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.
Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 1: SAD All-causality TEAEs	1 Participants	1 Participants	2 Participants	2 Participants
Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 1: SAD Treatment-related TEAEs	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 1: SAD All-causality SAEs	1 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 1: SAD Treatment-related SAEs	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 1: SAD All-causality severe AEs	1 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 1: SAD Treatment-related severe AEs	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 1 to 41 days

Population: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for the given part of the study (Part 2: MAD). Participants were analyzed according to the product they actually received.

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. A serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. An adverse event was considered a treatment-emergent adverse event (TEAE) if the event started during the effective duration of treatment.

Outcome measures

Measure	Part 1: PF-07304814 500 mg 24-hours Continuous Infusion n=6 Participants Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion.	Part 1: PF-07304814 250 mg 24-hours Continuous Infusion n=7 Participants Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion.	Part 1: 500 mg Placebo 24-hours Continuous Infusion n=4 Participants Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.	Part 1: 250 mg Placebo 24-hours Continuous Infusion Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.
Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 2: MAD Treatment-related TEAEs	0 Participants	0 Participants	1 Participants	—
Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 2: MAD All-causality TEAEs	2 Participants	4 Participants	3 Participants	—
Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 2: MAD All-causality SAEs	1 Participants	2 Participants	1 Participants	—
Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 2: MAD Treatment-related SAEs	0 Participants	0 Participants	0 Participants	—
Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 2: MAD All-causality severe AEs	0 Participants	2 Participants	1 Participants	—
Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 2: MAD Treatment-related severe AEs	0 Participants	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: Day 1 up to 37 days

Population: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for the given part of the study (Part 1: SAD). Participants were analyzed according to the product they actually received.

An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment.

Outcome measures

Measure	Part 1: PF-07304814 500 mg 24-hours Continuous Infusion n=2 Participants Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion.	Part 1: PF-07304814 250 mg 24-hours Continuous Infusion n=2 Participants Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion.	Part 1: 500 mg Placebo 24-hours Continuous Infusion n=2 Participants Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.	Part 1: 250 mg Placebo 24-hours Continuous Infusion n=2 Participants Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.
Number of Participants With Discontinuations From Study/Study Drug or Dose Reduction Due to TEAEs - Part 1: SAD Discontinued from study due to adverse events	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Discontinuations From Study/Study Drug or Dose Reduction Due to TEAEs - Part 1: SAD Discontinuation from study drug due to AE and continued study	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Discontinuations From Study/Study Drug or Dose Reduction Due to TEAEs - Part 1: SAD Dose reduced or temporary discontinuation due to adverse events	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 1 to 41 days

Population: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for the given part of the study (Part 2: MAD). Participants were analyzed according to the product they actually received.

An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a Treatment-Emergent Adverse Event (TEAE) if the event started during the effective duration of treatment.

Outcome measures

Measure	Part 1: PF-07304814 500 mg 24-hours Continuous Infusion n=6 Participants Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion.	Part 1: PF-07304814 250 mg 24-hours Continuous Infusion n=7 Participants Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion.	Part 1: 500 mg Placebo 24-hours Continuous Infusion n=4 Participants Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.	Part 1: 250 mg Placebo 24-hours Continuous Infusion Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.
Number of Participants With Discontinuations From Study/Study Drug or Dose Reduction Due to TEAEs - Part 2: MAD Discontinued from study due to adverse events	0 Participants	0 Participants	1 Participants	—
Number of Participants With Discontinuations From Study/Study Drug or Dose Reduction Due to TEAEs - Part 2: MAD Discontinuation from study drug due to AE and continued study	0 Participants	0 Participants	0 Participants	—
Number of Participants With Discontinuations From Study/Study Drug or Dose Reduction Due to TEAEs - Part 2: MAD Dose reduced or temporary discontinuation due to adverse events	1 Participants	0 Participants	0 Participants	—

PRIMARY outcome

Timeframe: Day 1 up to 6 days

Population: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for the given part of the study (Part 1: SAD). Participants were analyzed according to the product they actually received. Number of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific parameters.

Laboratory abnormalities reported in at least 1 participant are presented in this OM, including: Hematology - lymphocytes, basophiles; Clinical Chemistry - aspartate aminotransferase, alanine aminotransferase, calcium, bicarbonate, glucose, glucose -FASTING; Urinalysis - urine glucose, urine hemoglobin, urobilinogen and urine erythrocytes (per high power field).

Baseline was the last pre-dose measurement. LLN = lower limit of normal, ULN = upper limit of normal.

Outcome measures

Measure	Part 1: PF-07304814 500 mg 24-hours Continuous Infusion n=2 Participants Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion.	Part 1: PF-07304814 250 mg 24-hours Continuous Infusion n=2 Participants Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion.	Part 1: 500 mg Placebo 24-hours Continuous Infusion n=2 Participants Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.	Part 1: 250 mg Placebo 24-hours Continuous Infusion n=2 Participants Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.
Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD Lymphocytes (10^3/mm3) < 0.8*LLN	1 Participants	2 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD Basophils (10^3/mm3) > 1.2*ULN	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD Aspartate Aminotransferase (U/L) > 3.0*ULN	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD Alanine Aminotransferase (U/L) > 3.0*ULN	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD Calcium (mg/dL) < 0.9*LLN	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD Bicarbonate (mEq/L) < 0.9*LLN	0 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD Glucose (mg/dL) > 1.5*ULN	0 Participants	1 Participants	0 Participants	2 Participants
Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD Glucose - FASTING (mg/dL) >1.5*ULN	1 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD URINE Glucose ≥ 1	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD URINE Hemoglobin ≥ 1	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD Urobilinogen ≥ 1	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD URINE Erythrocytes (/HPF) ≥ 20	0 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Day 1 up to 41 days

Population: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for the given part of the study (Part 2: MAD). Participants were analyzed according to the product they actually received. Number of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific parameters.

Laboratory abnormalities reported in at least 1 participant are presented in this OM, including: Hematology - lymphocytes hemoglobin, hematocrit, erythrocytes, ery. mean corpuscular volume, ery. mean corpuscular, hemoglobin; Clinical Chemistry - alanine aminotransferase, protein, albumin, urea nitrogen, creatinine, HDL cholesterol, triglycerides, calcium, phosphate, bicarbonate, glucose; Urinalysis - urine glucose, ketones, urine hemoglobin, urobilinogen, nitrite, leukocyte esterase, urine erythrocytes (per high power field), urine leukocytes (Scalar).

Baseline was the last pre-dose measurement. LLN = lower limit of normal, ULN = upper limit of normal

Outcome measures

Measure	Part 1: PF-07304814 500 mg 24-hours Continuous Infusion n=6 Participants Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion.	Part 1: PF-07304814 250 mg 24-hours Continuous Infusion n=7 Participants Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion.	Part 1: 500 mg Placebo 24-hours Continuous Infusion n=4 Participants Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.	Part 1: 250 mg Placebo 24-hours Continuous Infusion Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.
Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD Hemoglobin (g/dL)<0.8*LLN	0 Participants	2 Participants	1 Participants	—
Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD Hematocrit (%)<0.8x LLN	0 Participants	2 Participants	0 Participants	—
Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD Erythrocytes (10^6/mm3)<0.8x LLN	0 Participants	1 Participants	0 Participants	—
Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD Ery. mean corpuscular volume (um^3)<0.9*LLN	0 Participants	1 Participants	1 Participants	—
Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD Ery. mean corpuscular hemoglobin (pg/cell)<0.9*LLN	0 Participants	1 Participants	1 Participants	—
Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD Lymphocytes (10^3/mm3)<0.8x LLN	0 Participants	3 Participants	3 Participants	—
Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD Alanine aminotransferase (U/L)>3.0*ULN	0 Participants	1 Participants	1 Participants	—
Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD Protein (g/dL)<0.8x LLN	0 Participants	1 Participants	1 Participants	—
Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD Albumin (g/dL) <0.8x LLN	1 Participants	0 Participants	1 Participants	—
Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD Urea nitrogen (mg/dL)>1.3x ULN	0 Participants	0 Participants	1 Participants	—
Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD Creatinine (mg/dL)>1.3x ULN	0 Participants	0 Participants	1 Participants	—
Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD HDL cholesterol (mg/dL)<0.8x LLN	2 Participants	3 Participants	1 Participants	—
Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD Triglycerides (mg/dL)>1.3x ULN	1 Participants	1 Participants	0 Participants	—
Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD Calcium (mg/dL)<0.9x LLN	1 Participants	1 Participants	0 Participants	—
Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD Phosphate (mg/dL)<0.8x LLN	0 Participants	1 Participants	0 Participants	—
Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD Bicarbonate (mEq/L)<0.9x LLN	2 Participants	4 Participants	3 Participants	—
Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD Glucose (mg/dL)>1.5x ULN	3 Participants	6 Participants	2 Participants	—
Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD URINE glucose≥1	1 Participants	1 Participants	0 Participants	—
Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD Ketones≥1	0 Participants	1 Participants	0 Participants	—
Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD Urine hemoglobin ≥ 1	1 Participants	2 Participants	1 Participants	—
Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD Urobilinogen≥1	1 Participants	2 Participants	1 Participants	—
Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD Nitrite≥1	1 Participants	0 Participants	0 Participants	—
Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD Leukocyte esterase ≥ 1	1 Participants	2 Participants	0 Participants	—
Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD Urine erythrocytes (/HPF)≥20	1 Participants	2 Participants	0 Participants	—
Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD Urine leukocytes (Scalar)≥20	0 Participants	1 Participants	0 Participants	—

PRIMARY outcome

Timeframe: Baseline (pre-dose Day 1), Day 1-30 minutes, 2 hours, 6 hour, and 12 hours; 24 hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2).

Population: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for Part 1 (SAD) of the study. Participants were be analyzed according to the product they received. Number of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific time point.

Absolute baseline values and changes from baseline in supine systolic and diastolic blood pressure were summarized by treatment and time post-dose. Blood pressure was assessed in the supine position after at least 5 minutes of rest in a quiet setting without distractions. Baseline was defined as the last pre-dose measurement.

Outcome measures

Measure	Part 1: PF-07304814 500 mg 24-hours Continuous Infusion n=2 Participants Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion.	Part 1: PF-07304814 250 mg 24-hours Continuous Infusion n=2 Participants Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion.	Part 1: 500 mg Placebo 24-hours Continuous Infusion n=2 Participants Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.	Part 1: 250 mg Placebo 24-hours Continuous Infusion n=2 Participants Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.
Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Systolic blood pressure: Change from Baseline: End of Treatment	-5.0 mmHg Standard Deviation 16.97	-17.0 mmHg Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	0.0 mmHg Standard Deviation 8.49	-1.0 mmHg Standard Deviation 5.66
Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Systolic blood pressure: Change from Baseline: Follow Up 1	8.0 mmHg Standard Deviation 11.31	-16.5 mmHg Standard Deviation 21.92	-3.0 mmHg Standard Deviation 9.90	13.5 mmHg Standard Deviation 3.54
Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Systolic blood pressure: Change from Baseline: Follow Up 2	17.0 mmHg Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	-20.0 mmHg Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	-6.0 mmHg Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	-14.5 mmHg Standard Deviation 27.58
Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Diastolic blood pressure: Baseline	64.0 mmHg Standard Deviation 9.90	59.0 mmHg Standard Deviation 21.21	68.5 mmHg Standard Deviation 13.44	76.5 mmHg Standard Deviation 9.19
Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Diastolic blood pressure: Change from Baseline: Day 1 - 30 minutes	5.0 mmHg Standard Deviation 5.66	16.0 mmHg Standard Deviation 14.14	-5.0 mmHg Standard Deviation 8.49	6.0 mmHg Standard Deviation 9.90
Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Diastolic blood pressure: Change from Baseline: Day 1 - 2 hours	9.5 mmHg Standard Deviation 12.02	11.5 mmHg Standard Deviation 7.78	-2.0 mmHg Standard Deviation 4.24	3.0 mmHg Standard Deviation 11.31
Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Diastolic blood pressure: Change from Baseline: Day 1 - 6 hours	-1.5 mmHg Standard Deviation 6.36	8.5 mmHg Standard Deviation 17.68	-8.0 mmHg Standard Deviation 7.07	6.5 mmHg Standard Deviation 7.78
Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Diastolic blood pressure: Change from Baseline: Day 1 - 12 hours	9.0 mmHg Standard Deviation 9.90	13.0 mmHg Standard Deviation 16.97	-8.5 mmHg Standard Deviation 2.12	-1.0 mmHg Standard Deviation 0.00
Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Diastolic blood pressure: Change from Baseline: End of Treatment	-1.0 mmHg Standard Deviation 0.00	23.0 mmHg Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	-7.5 mmHg Standard Deviation 6.36	-4.5 mmHg Standard Deviation 0.71
Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Diastolic blood pressure: Change from Baseline: Follow Up 1	17.0 mmHg Standard Deviation 2.83	6.0 mmHg Standard Deviation 2.83	-6.0 mmHg Standard Deviation 1.41	8.5 mmHg Standard Deviation 2.12
Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Diastolic blood pressure: Change from Baseline: Follow Up 2	12.0 mmHg Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed	17.0 mmHg Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed	-11.0 mmHg Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed	-2.0 mmHg Standard Deviation 12.73
Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Systolic blood pressure: Baseline	116.0 mmHg Standard Deviation 4.24	134.5 mmHg Standard Deviation 13.44	108.0 mmHg Standard Deviation 14.14	127.5 mmHg Standard Deviation 30.41
Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Systolic blood pressure: Change from Baseline: Day 1- 30 minutes	6.0 mmHg Standard Deviation 18.38	-12.5 mmHg Standard Deviation 12.02	-4.0 mmHg Standard Deviation 12.73	9.5 mmHg Standard Deviation 17.68
Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Systolic blood pressure: Change from Baseline: Day 1 - 2 hours	12.0 mmHg Standard Deviation 22.63	-20.0 mmHg Standard Deviation 11.31	4.0 mmHg Standard Deviation 2.83	3.5 mmHg Standard Deviation 20.51
Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Systolic blood pressure: Change from Baseline: Day 1 - 6 hours	-1.5 mmHg Standard Deviation 14.85	-20.5 mmHg Standard Deviation 13.44	0.0 mmHg Standard Deviation 7.07	16.5 mmHg Standard Deviation 24.75
Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Systolic blood pressure: Change from Baseline: Day 1 - 12 hours	-8.0 mmHg Standard Deviation 18.38	-6.5 mmHg Standard Deviation 26.16	-2.5 mmHg Standard Deviation 4.95	10.0 mmHg Standard Deviation 5.66

PRIMARY outcome

Timeframe: Baseline (pre-dose Day 1), Day 2, 3, 4, 5; 120 hours (End of Treatment), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (between Day 34-41) and/or early termination (ET) .

Population: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for Part 2 (MAD) of the study. Participants were be analyzed according to the product they received. Number of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific time point.

Absolute baseline values and changes from baseline in supine systolic and diastolic blood pressure were summarized by treatment and time post-dose. Blood pressure was assessed in the supine position after at least 5 minutes of rest in a quiet setting without distractions. Baseline was defined as the last pre-dose measurement.

Outcome measures

Measure	Part 1: PF-07304814 500 mg 24-hours Continuous Infusion n=6 Participants Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion.	Part 1: PF-07304814 250 mg 24-hours Continuous Infusion n=7 Participants Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion.	Part 1: 500 mg Placebo 24-hours Continuous Infusion n=4 Participants Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.	Part 1: 250 mg Placebo 24-hours Continuous Infusion Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.
Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day2,3,4,5, and 6 (120 Hours), Day7 (Follow-up 1), Day10 (Follow-up 2), Day14 (Follow-up 3), Between Day34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Diastolic blood pressure: Baseline	63.8 mmHg Standard Deviation 11.39	78.7 mmHg Standard Deviation 7.87	72.0 mmHg Standard Deviation 12.52	—
Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day2,3,4,5, and 6 (120 Hours), Day7 (Follow-up 1), Day10 (Follow-up 2), Day14 (Follow-up 3), Between Day34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Diastolic blood pressure: Change from Baseline: Day 2	4.7 mmHg Standard Deviation 10.52	-2.4 mmHg Standard Deviation 7.48	1.0 mmHg Standard Deviation 9.83	—
Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day2,3,4,5, and 6 (120 Hours), Day7 (Follow-up 1), Day10 (Follow-up 2), Day14 (Follow-up 3), Between Day34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Diastolic blood pressure: Change from Baseline: Day 3	7.8 mmHg Standard Deviation 10.96	-9.4 mmHg Standard Deviation 13.15	2.3 mmHg Standard Deviation 9.54	—
Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day2,3,4,5, and 6 (120 Hours), Day7 (Follow-up 1), Day10 (Follow-up 2), Day14 (Follow-up 3), Between Day34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Diastolic blood pressure: Change from Baseline: Day 4	2.7 mmHg Standard Deviation 8.57	-7.4 mmHg Standard Deviation 9.32	-11.7 mmHg Standard Deviation 4.93	—
Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day2,3,4,5, and 6 (120 Hours), Day7 (Follow-up 1), Day10 (Follow-up 2), Day14 (Follow-up 3), Between Day34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Diastolic blood pressure: Change from Baseline: Day 5	2.7 mmHg Standard Deviation 10.05	-9.6 mmHg Standard Deviation 11.62	2.0 mmHg Standard Deviation 11.27	—
Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day2,3,4,5, and 6 (120 Hours), Day7 (Follow-up 1), Day10 (Follow-up 2), Day14 (Follow-up 3), Between Day34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Diastolic blood pressure: Change from Baseline: End of Treatment	2.5 mmHg Standard Deviation 8.96	-7.9 mmHg Standard Deviation 17.00	-13.0 mmHg Standard Deviation 2.00	—
Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day2,3,4,5, and 6 (120 Hours), Day7 (Follow-up 1), Day10 (Follow-up 2), Day14 (Follow-up 3), Between Day34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Systolic blood pressure: Baseline	105.3 mmHg Standard Deviation 18.08	127.6 mmHg Standard Deviation 13.64	116.5 mmHg Standard Deviation 14.29	—
Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day2,3,4,5, and 6 (120 Hours), Day7 (Follow-up 1), Day10 (Follow-up 2), Day14 (Follow-up 3), Between Day34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Systolic blood pressure: Change from Baseline: Day 2	4.8 mmHg Standard Deviation 10.34	1.4 mmHg Standard Deviation 14.20	-4.3 mmHg Standard Deviation 8.42	—
Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day2,3,4,5, and 6 (120 Hours), Day7 (Follow-up 1), Day10 (Follow-up 2), Day14 (Follow-up 3), Between Day34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Systolic blood pressure: Change from Baseline: Day 3	15.5 mmHg Standard Deviation 14.15	-4.9 mmHg Standard Deviation 16.92	10.8 mmHg Standard Deviation 24.70	—
Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day2,3,4,5, and 6 (120 Hours), Day7 (Follow-up 1), Day10 (Follow-up 2), Day14 (Follow-up 3), Between Day34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Systolic blood pressure: Change from Baseline: Day 4	-1.2 mmHg Standard Deviation 12.54	-13.1 mmHg Standard Deviation 13.59	-18.0 mmHg Standard Deviation 6.00	—
Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day2,3,4,5, and 6 (120 Hours), Day7 (Follow-up 1), Day10 (Follow-up 2), Day14 (Follow-up 3), Between Day34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Systolic blood pressure: Change from Baseline: Day 5	3.2 mmHg Standard Deviation 10.28	-4.6 mmHg Standard Deviation 14.14	-12.3 mmHg Standard Deviation 6.66	—
Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day2,3,4,5, and 6 (120 Hours), Day7 (Follow-up 1), Day10 (Follow-up 2), Day14 (Follow-up 3), Between Day34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Systolic blood pressure: Change from Baseline: End of Treatment	3.7 mmHg Standard Deviation 14.85	-11.6 mmHg Standard Deviation 12.71	-11.0 mmHg Standard Deviation 6.08	—
Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day2,3,4,5, and 6 (120 Hours), Day7 (Follow-up 1), Day10 (Follow-up 2), Day14 (Follow-up 3), Between Day34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Systolic blood pressure: Change from Baseline: Early Termination	—	—	11.0 mmHg Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—
Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day2,3,4,5, and 6 (120 Hours), Day7 (Follow-up 1), Day10 (Follow-up 2), Day14 (Follow-up 3), Between Day34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Systolic blood pressure: Change from Baseline: Follow Up 1	5.0 mmHg Standard Deviation 14.14	-7.7 mmHg Standard Deviation 10.83	4.5 mmHg Standard Deviation 17.29	—
Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day2,3,4,5, and 6 (120 Hours), Day7 (Follow-up 1), Day10 (Follow-up 2), Day14 (Follow-up 3), Between Day34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Systolic blood pressure: Change from Baseline: Follow Up 2	21.5 mmHg Standard Deviation 17.62	1.0 mmHg Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	24.0 mmHg Standard Deviation 48.08	—
Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day2,3,4,5, and 6 (120 Hours), Day7 (Follow-up 1), Day10 (Follow-up 2), Day14 (Follow-up 3), Between Day34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Systolic blood pressure: Change from Baseline: Follow Up 3	19.0 mmHg Standard Deviation 14.07	-1.0 mmHg Standard Deviation 2.83	11.7 mmHg Standard Deviation 17.01	—
Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day2,3,4,5, and 6 (120 Hours), Day7 (Follow-up 1), Day10 (Follow-up 2), Day14 (Follow-up 3), Between Day34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Systolic blood pressure: Change from Baseline: Follow Up 4	15.0 mmHg Standard Deviation 2.83	-2.7 mmHg Standard Deviation 6.66	15.0 mmHg Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—
Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day2,3,4,5, and 6 (120 Hours), Day7 (Follow-up 1), Day10 (Follow-up 2), Day14 (Follow-up 3), Between Day34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Diastolic blood pressure: Change from Baseline: Early Termination	—	—	11.0 mmHg Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—
Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day2,3,4,5, and 6 (120 Hours), Day7 (Follow-up 1), Day10 (Follow-up 2), Day14 (Follow-up 3), Between Day34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Diastolic blood pressure: Change from Baseline: Follow Up 1	4.8 mmHg Standard Deviation 11.34	-6.7 mmHg Standard Deviation 13.86	-5.8 mmHg Standard Deviation 12.04	—
Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day2,3,4,5, and 6 (120 Hours), Day7 (Follow-up 1), Day10 (Follow-up 2), Day14 (Follow-up 3), Between Day34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Diastolic blood pressure: Change from Baseline: Follow Up 2	15.5 mmHg Standard Deviation 13.48	-34.0 mmHg Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	-3.0 mmHg Standard Deviation 1.41	—
Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day2,3,4,5, and 6 (120 Hours), Day7 (Follow-up 1), Day10 (Follow-up 2), Day14 (Follow-up 3), Between Day34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Diastolic blood pressure: Change from Baseline: Follow Up 3	13.0 mmHg Standard Deviation 13.64	-14.5 mmHg Standard Deviation 13.44	5.0 mmHg Standard Deviation 21.63	—
Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day2,3,4,5, and 6 (120 Hours), Day7 (Follow-up 1), Day10 (Follow-up 2), Day14 (Follow-up 3), Between Day34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Diastolic blood pressure: Change from Baseline: Follow Up 4	11.0 mmHg Standard Deviation 14.14	-4.3 mmHg Standard Deviation 12.66	12.0 mmHg Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—

PRIMARY outcome

Timeframe: Baseline (pre-dose Day 1), 30 minutes, 2 hours, 6 hour, and 12 hours (post-dose Day 1); 24 hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2).

Population: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for Part 1 (SAD) of the study. Participants were be analyzed according to the product they received. Number of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific time point.

Absolute baseline values and changes from baseline in pulse rate were summarized by treatment and time post-dose. Baseline was defined as the last pre-dose measurement.

Outcome measures

Measure	Part 1: PF-07304814 500 mg 24-hours Continuous Infusion n=2 Participants Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion.	Part 1: PF-07304814 250 mg 24-hours Continuous Infusion n=2 Participants Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion.	Part 1: 500 mg Placebo 24-hours Continuous Infusion n=2 Participants Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.	Part 1: 250 mg Placebo 24-hours Continuous Infusion n=2 Participants Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.
Summary of Baseline and Change From Baseline in Pulse Rate at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Pulse rate: Baseline	83.0 bpm Standard Deviation 2.83	74.5 bpm Standard Deviation 4.95	66.0 bpm Standard Deviation 16.97	75.5 bpm Standard Deviation 6.36
Summary of Baseline and Change From Baseline in Pulse Rate at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Pulse rate: Change from Baseline: Day 1 - 30 minutes	1.0 bpm Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	10.0 bpm Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	-1.0 bpm Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	6.5 bpm Standard Deviation 0.71
Summary of Baseline and Change From Baseline in Pulse Rate at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Pulse rate: Change from Baseline: Day 1 - 2 hours	-2.0 bpm Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	2.5 bpm Standard Deviation 3.54	-5.0 bpm Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	16.0 bpm Standard Deviation 24.04
Summary of Baseline and Change From Baseline in Pulse Rate at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Pulse rate: Change from Baseline: Day 1 - 6 hours	-6.0 bpm Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	-8.0 bpm Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	-7.0 bpm Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—
Summary of Baseline and Change From Baseline in Pulse Rate at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Pulse rate: Change from Baseline: Day 1 - 12 hours	-12.0 bpm Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	0.0 bpm Standard Deviation 0.00	-11.0 bpm Standard Deviation 1.41	6.0 bpm Standard Deviation 7.07
Summary of Baseline and Change From Baseline in Pulse Rate at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Pulse rate: Change from Baseline: End of Treatment	-5.5 bpm Standard Deviation 0.71	-4.5 bpm Standard Deviation 17.68	2.5 bpm Standard Deviation 10.61	-17.0 bpm Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.
Summary of Baseline and Change From Baseline in Pulse Rate at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Pulse rate: Change from Baseline: Follow Up 1	-2.5 bpm Standard Deviation 7.78	-7.0 bpm Standard Deviation 1.41	-1.0 bpm Standard Deviation 1.41	15.0 bpm Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.
Summary of Baseline and Change From Baseline in Pulse Rate at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Pulse rate: Change from Baseline: Follow Up 2	4.0 bpm Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	3.0 bpm Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	5.0 bpm Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	5.0 bpm Standard Deviation 9.90

PRIMARY outcome

Timeframe: Baseline (pre-dose Day 1); Day 2, 3, 4, 5; 120 hours (End of Treatment), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (between Day 34-41) and/or early termination (ET).

Population: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for Part 2 (MAD) of the study. Participants were be analyzed according to the product they received. Number of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific time point.

Absolute baseline values and changes from baseline in pulse rate were summarized by treatment and time post-dose. Baseline was defined as the last pre-dose measurement.

Outcome measures

Measure	Part 1: PF-07304814 500 mg 24-hours Continuous Infusion n=6 Participants Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion.	Part 1: PF-07304814 250 mg 24-hours Continuous Infusion n=7 Participants Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion.	Part 1: 500 mg Placebo 24-hours Continuous Infusion n=4 Participants Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.	Part 1: 250 mg Placebo 24-hours Continuous Infusion Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.
Summary of Baseline and Change From Baseline in Pulse Rate at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Pulse rate: Baseline	74.2 bpm Standard Deviation 10.59	80.9 bpm Standard Deviation 13.15	90.3 bpm Standard Deviation 30.38	—
Summary of Baseline and Change From Baseline in Pulse Rate at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Pulse rate: Change from Baseline: Day 2	-4.0 bpm Standard Deviation 16.82	-5.4 bpm Standard Deviation 10.64	-1.5 bpm Standard Deviation 4.12	—
Summary of Baseline and Change From Baseline in Pulse Rate at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Pulse rate: Change from Baseline: Day 3	3.5 bpm Standard Deviation 11.52	-6.6 bpm Standard Deviation 20.90	-3.0 bpm Standard Deviation 8.60	—
Summary of Baseline and Change From Baseline in Pulse Rate at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Pulse rate: Change from Baseline: Day 4	-6.0 bpm Standard Deviation 17.47	-10.6 bpm Standard Deviation 10.39	-18.3 bpm Standard Deviation 24.79	—
Summary of Baseline and Change From Baseline in Pulse Rate at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Pulse rate: Change from Baseline: Day 5	-2.3 bpm Standard Deviation 11.11	-8.4 bpm Standard Deviation 12.61	-12.0 bpm Standard Deviation 22.07	—
Summary of Baseline and Change From Baseline in Pulse Rate at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Pulse rate: Change from Baseline: End of Treatment	-7.8 bpm Standard Deviation 20.65	-9.1 bpm Standard Deviation 16.34	-19.7 bpm Standard Deviation 45.39	—
Summary of Baseline and Change From Baseline in Pulse Rate at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Pulse rate: Change from Baseline: Early Termination	—	—	-3.0 bpm Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed	—
Summary of Baseline and Change From Baseline in Pulse Rate at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Pulse rate: Change from Baseline: Follow Up 1	-1.3 bpm Standard Deviation 9.93	-9.7 bpm Standard Deviation 12.58	-11.3 bpm Standard Deviation 32.46	—
Summary of Baseline and Change From Baseline in Pulse Rate at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Pulse rate: Change from Baseline: Follow Up 2	13.0 bpm Standard Deviation 9.83	-38.0 bpm Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed	-25.5 bpm Standard Deviation 24.75	—
Summary of Baseline and Change From Baseline in Pulse Rate at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Pulse rate: Change from Baseline: Follow Up 3	8.8 bpm Standard Deviation 10.24	6.0 bpm Standard Deviation 29.70	-7.7 bpm Standard Deviation 28.36	—
Summary of Baseline and Change From Baseline in Pulse Rate at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Pulse rate: Change from Baseline: Follow Up 4	12.0 bpm Standard Deviation 12.73	8.3 bpm Standard Deviation 24.95	12.0 bpm Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed	—

PRIMARY outcome

Timeframe: Baseline (pre-dose Day 1); 30 minutes, 2 hours, 6 hour, and 12 hours (post-dose Day1); 24 hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2).

Population: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for Part 1 (SAD) of the study. Participants were be analyzed according to the product they received. Number of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific time point.

Absolute baseline values and changes from baseline in temperature were summarized by treatment and time post-dose. Baseline was defined as the last pre-dose measurement.

Outcome measures

Measure	Part 1: PF-07304814 500 mg 24-hours Continuous Infusion n=2 Participants Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion.	Part 1: PF-07304814 250 mg 24-hours Continuous Infusion n=2 Participants Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion.	Part 1: 500 mg Placebo 24-hours Continuous Infusion n=2 Participants Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.	Part 1: 250 mg Placebo 24-hours Continuous Infusion n=2 Participants Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.
Summary of Baseline and Change From Baseline in Temperature at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Temperature: Change from Baseline: Day 1 - 30 minutes	0.2 Degree Celsius Standard Deviation 0.21	-0.2 Degree Celsius Standard Deviation 0.21	0.1 Degree Celsius Standard Deviation 0.07	0.2 Degree Celsius Standard Deviation 0.00
Summary of Baseline and Change From Baseline in Temperature at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Temperature: Change from Baseline: Day 1 - 2 hours	0.1 Degree Celsius Standard Deviation 0.49	-0.1 Degree Celsius Standard Deviation 0.07	0.1 Degree Celsius Standard Deviation 0.14	-0.1 Degree Celsius Standard Deviation 0.57
Summary of Baseline and Change From Baseline in Temperature at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Temperature: Change from Baseline: Day 1 - 6 hours	-0.4 Degree Celsius Standard Deviation 0.28	0.0 Degree Celsius Standard Deviation 0.14	0.2 Degree Celsius Standard Deviation 0.07	0.1 Degree Celsius Standard Deviation 0.71
Summary of Baseline and Change From Baseline in Temperature at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Temperature: Change from Baseline: Day 1 - 12 hours	-0.1 Degree Celsius Standard Deviation 0.99	-0.5 Degree Celsius Standard Deviation 0.14	0.1 Degree Celsius Standard Deviation 0.00	0.7 Degree Celsius Standard Deviation 0.42
Summary of Baseline and Change From Baseline in Temperature at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Temperature: Change from Baseline: End of Treatment	-0.7 Degree Celsius Standard Deviation 0.64	-0.1 Degree Celsius Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	0.3 Degree Celsius Standard Deviation 0.35	0.3 Degree Celsius Standard Deviation 0.64
Summary of Baseline and Change From Baseline in Temperature at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Temperature: Change from Baseline: Follow Up 1	-0.9 Degree Celsius Standard Deviation 0.78	-0.7 Degree Celsius Standard Deviation 0.07	0.3 Degree Celsius Standard Deviation 0.07	-0.3 Degree Celsius Standard Deviation 0.85
Summary of Baseline and Change From Baseline in Temperature at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Temperature: Change from Baseline: Follow Up 2	-0.9 Degree Celsius Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	2.0 Degree Celsius Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	0.3 Degree Celsius Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	0.1 Degree Celsius Standard Deviation 0.35
Summary of Baseline and Change From Baseline in Temperature at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Temperature: Baseline	37.6 Degree Celsius Standard Deviation 0.14	37.0 Degree Celsius Standard Deviation 0.28	36.5 Degree Celsius Standard Deviation 0.14	37.1 Degree Celsius Standard Deviation 0.99

PRIMARY outcome

Timeframe: Baseline (pre-dose Day 1); Day 2, 3, 4, 5; 120 hours (End of Treatment), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (between Day 34-41) and/or early termination (ET).

Population: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for Part 2 (MAD) of the study. Participants were be analyzed according to the product they received. Number of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific time point.

Absolute baseline values and changes from baseline in temperature were summarized by treatment and time post-dose. Baseline was defined as the last pre-dose measurement.

Outcome measures

Measure	Part 1: PF-07304814 500 mg 24-hours Continuous Infusion n=6 Participants Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion.	Part 1: PF-07304814 250 mg 24-hours Continuous Infusion n=7 Participants Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion.	Part 1: 500 mg Placebo 24-hours Continuous Infusion n=4 Participants Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.	Part 1: 250 mg Placebo 24-hours Continuous Infusion Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.
Summary of Baseline and Change From Baseline in Temperature at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Temperature: Change from Baseline: Day 4	-0.3 Degree Celsius Standard Deviation 0.91	-0.4 Degree Celsius Standard Deviation 0.45	0.0 Degree Celsius Standard Deviation 0.40	—
Summary of Baseline and Change From Baseline in Temperature at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Temperature: Change from Baseline: Day 5	-0.4 Degree Celsius Standard Deviation 0.97	-0.6 Degree Celsius Standard Deviation 0.60	0.4 Degree Celsius Standard Deviation 0.55	—
Summary of Baseline and Change From Baseline in Temperature at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Temperature: Change from Baseline: End of Treatment	-0.4 Degree Celsius Standard Deviation 0.91	-0.6 Degree Celsius Standard Deviation 0.59	0.5 Degree Celsius Standard Deviation 0.45	—
Summary of Baseline and Change From Baseline in Temperature at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Temperature: Change from Baseline: Early Termination	—	—	-0.3 Degree Celsius Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed	—
Summary of Baseline and Change From Baseline in Temperature at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Temperature: Change from Baseline: Follow Up 1	-0.4 Degree Celsius Standard Deviation 0.91	-0.6 Degree Celsius Standard Deviation 0.46	0.7 Degree Celsius Standard Deviation 0.17	—
Summary of Baseline and Change From Baseline in Temperature at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Temperature: Change from Baseline: Follow Up 2	-0.1 Degree Celsius Standard Deviation 1.21	-0.1 Degree Celsius Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed	0.7 Degree Celsius Standard Deviation 0.57	—
Summary of Baseline and Change From Baseline in Temperature at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Temperature: Change from Baseline: Follow Up 3	-0.4 Degree Celsius Standard Deviation 1.05	-0.1 Degree Celsius Standard Deviation 0.21	0.7 Degree Celsius Standard Deviation 1.08	—
Summary of Baseline and Change From Baseline in Temperature at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Temperature: Change from Baseline: Follow Up 4	-1.0 Degree Celsius Standard Deviation 0.64	0.2 Degree Celsius Standard Deviation 0.67	-0.2 Degree Celsius Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed	—
Summary of Baseline and Change From Baseline in Temperature at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Temperature: Baseline	36.7 Degree Celsius Standard Deviation 0.79	36.7 Degree Celsius Standard Deviation 0.35	36.3 Degree Celsius Standard Deviation 0.73	—
Summary of Baseline and Change From Baseline in Temperature at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Temperature: Change from Baseline: Day 2	-0.4 Degree Celsius Standard Deviation 0.88	-0.3 Degree Celsius Standard Deviation 0.50	0.2 Degree Celsius Standard Deviation 0.29	—
Summary of Baseline and Change From Baseline in Temperature at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Temperature: Change from Baseline: Day 3	-0.2 Degree Celsius Standard Deviation 0.84	-0.3 Degree Celsius Standard Deviation 0.43	0.1 Degree Celsius Standard Deviation 0.43	—

PRIMARY outcome

Timeframe: Baseline (pre-dose Day 1); 30 minutes, 2 hours, 6 hour, and 12 hours (post-dose Day1); 24 hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2).

Population: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for Part 1 (SAD) of the study. Participants were be analyzed according to the product they received. Number of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific time point.

Absolute baseline values and changes from baseline in respiratory rate were summarized by treatment and time post-dose. Baseline was defined as the last pre-dose measurement.

Outcome measures

Measure	Part 1: PF-07304814 500 mg 24-hours Continuous Infusion n=2 Participants Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion.	Part 1: PF-07304814 250 mg 24-hours Continuous Infusion n=2 Participants Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion.	Part 1: 500 mg Placebo 24-hours Continuous Infusion n=2 Participants Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.	Part 1: 250 mg Placebo 24-hours Continuous Infusion n=2 Participants Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.
Summary of Baseline and Change From Baseline in Respiratory Rate at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Respiratory rate: Baseline	21.0 breaths per minute Standard Deviation 1.41	20.5 breaths per minute Standard Deviation 3.54	23.0 breaths per minute Standard Deviation 7.07	20.0 breaths per minute Standard Deviation 2.83
Summary of Baseline and Change From Baseline in Respiratory Rate at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Respiratory rate: Change from Baseline: Day 1 - 30 minutes	0.0 breaths per minute Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	-1.0 breaths per minute Standard Deviation 4.24	-1.0 breaths per minute Standard Deviation 1.41	-0.5 breaths per minute Standard Deviation 0.71
Summary of Baseline and Change From Baseline in Respiratory Rate at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Respiratory rate: Change from Baseline: Day 1 - 2 hours	0.0 breaths per minute Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	-1.0 breaths per minute Standard Deviation 4.24	-1.0 breaths per minute Standard Deviation 1.41	6.5 breaths per minute Standard Deviation 7.78
Summary of Baseline and Change From Baseline in Respiratory Rate at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Respiratory rate: Change from Baseline: Day 1 - 6 hours	-2.0 breaths per minute Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	-0.5 breaths per minute Standard Deviation 0.71	-0.5 breaths per minute Standard Deviation 0.71	—
Summary of Baseline and Change From Baseline in Respiratory Rate at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Respiratory rate: Change from Baseline: Day 1 - 12 hours	-1.0 breaths per minute Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	-5.5 breaths per minute Standard Deviation 10.61	-2.5 breaths per minute Standard Deviation 4.95	0.0 breaths per minute Standard Deviation 0.00
Summary of Baseline and Change From Baseline in Respiratory Rate at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Respiratory rate: Change from Baseline: End of Treatment	-2.5 breaths per minute Standard Deviation 0.71	-0.5 breaths per minute Standard Deviation 2.12	2.5 breaths per minute Standard Deviation 3.54	7.0 breaths per minute Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.
Summary of Baseline and Change From Baseline in Respiratory Rate at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Respiratory rate: Change from Baseline: Follow Up 1	-4.0 breaths per minute Standard Deviation 2.83	0.5 breaths per minute Standard Deviation 7.78	-3.5 breaths per minute Standard Deviation 4.95	-4.0 breaths per minute Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.
Summary of Baseline and Change From Baseline in Respiratory Rate at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Respiratory rate: Change from Baseline: Follow Up 2	-8.0 breaths per minute Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	4.0 breaths per minute Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	-8.0 breaths per minute Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	-2.0 breaths per minute Standard Deviation 5.66

PRIMARY outcome

Timeframe: Baseline (pre-dose Day 1); Day 2, 3, 4, 5; 120 hours (End of Treatment), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (between Day 34-41) and/or early termination (ET).

Population: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for Part 2 (MAD) of the study. Participants were be analyzed according to the product they received. Number of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific time point.

Absolute baseline values and changes from baseline in respiratory rate were summarized by treatment and time post-dose. Baseline was defined as the last pre-dose measurement.

Outcome measures

Measure	Part 1: PF-07304814 500 mg 24-hours Continuous Infusion n=6 Participants Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion.	Part 1: PF-07304814 250 mg 24-hours Continuous Infusion n=7 Participants Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion.	Part 1: 500 mg Placebo 24-hours Continuous Infusion n=4 Participants Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.	Part 1: 250 mg Placebo 24-hours Continuous Infusion Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.
Summary of Baseline and Change From Baseline in Respiratory Rate at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Respiratory rate: Change from Baseline: Day 3	1.0 Breaths per minute Standard Deviation 8.99	-3.1 Breaths per minute Standard Deviation 4.26	1.0 Breaths per minute Standard Deviation 4.97	—
Summary of Baseline and Change From Baseline in Respiratory Rate at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Respiratory rate: Change from Baseline: Day 4	-1.8 Breaths per minute Standard Deviation 3.76	-4.0 Breaths per minute Standard Deviation 5.69	4.0 Breaths per minute Standard Deviation 5.00	—
Summary of Baseline and Change From Baseline in Respiratory Rate at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Respiratory rate: Change from Baseline: Follow Up 1	-3.5 Breaths per minute Standard Deviation 4.55	-3.9 Breaths per minute Standard Deviation 4.88	-3.0 Breaths per minute Standard Deviation 1.00	—
Summary of Baseline and Change From Baseline in Respiratory Rate at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Respiratory rate: Baseline	23.5 Breaths per minute Standard Deviation 3.45	22.4 Breaths per minute Standard Deviation 5.59	21.0 Breaths per minute Standard Deviation 4.69	—
Summary of Baseline and Change From Baseline in Respiratory Rate at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Respiratory rate: Change from Baseline: Day 2	-3.0 Breaths per minute Standard Deviation 7.10	-1.7 Breaths per minute Standard Deviation 7.45	-0.5 Breaths per minute Standard Deviation 5.07	—
Summary of Baseline and Change From Baseline in Respiratory Rate at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Respiratory rate: Change from Baseline: Day 5	-2.2 Breaths per minute Standard Deviation 5.78	-2.9 Breaths per minute Standard Deviation 2.04	-0.7 Breaths per minute Standard Deviation 2.08	—
Summary of Baseline and Change From Baseline in Respiratory Rate at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Respiratory rate: Change from Baseline: End of Treatment	-3.3 Breaths per minute Standard Deviation 4.27	-2.3 Breaths per minute Standard Deviation 5.62	-2.3 Breaths per minute Standard Deviation 3.51	—
Summary of Baseline and Change From Baseline in Respiratory Rate at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Respiratory rate: Change from Baseline: Early Termination	—	—	-4.0 Breaths per minute Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed	—
Summary of Baseline and Change From Baseline in Respiratory Rate at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Respiratory rate: Change from Baseline: Follow Up 2	-5.8 Breaths per minute Standard Deviation 6.50	-2.0 Breaths per minute Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed	-1.5 Breaths per minute Standard Deviation 2.12	—
Summary of Baseline and Change From Baseline in Respiratory Rate at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Respiratory rate: Change from Baseline: Follow Up 3	-6.8 Breaths per minute Standard Deviation 5.74	-10.0 Breaths per minute Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed	1.3 Breaths per minute Standard Deviation 10.12	—
Summary of Baseline and Change From Baseline in Respiratory Rate at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD Respiratory rate: Change from Baseline: Follow Up 4	-6.0 Breaths per minute Standard Deviation 5.66	1.3 Breaths per minute Standard Deviation 4.73	-3.0 Breaths per minute Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed	—

PRIMARY outcome

Timeframe: Baseline (pre-dose Day 1); Day1-24 hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2)

Population: All participants randomly assigned to study intervention and who take at least 1 dose of study intervention for the Part 1. Participants will be analyzed according to the product they actually received. Number of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific time point.

Percent SpO2 values at baseline and changes from baseline were summarized for participants in 3 categories: (1) participants who received supplemental oxygen throughout, (2) participants who received supplemental oxygen at some point during the study, and (3) participants who never received supplemental oxygen. Baseline of pulse oximetry/SpO2 was defined as the last pre-dose measurement.

SpO2 = arterial oxygen saturation.

Outcome measures

Measure	Part 1: PF-07304814 500 mg 24-hours Continuous Infusion n=2 Participants Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion.	Part 1: PF-07304814 250 mg 24-hours Continuous Infusion n=2 Participants Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion.	Part 1: 500 mg Placebo 24-hours Continuous Infusion n=2 Participants Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.	Part 1: 250 mg Placebo 24-hours Continuous Infusion n=2 Participants Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.
Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at 24 Hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Baseline: Oxygen Received Throughout	92.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	90.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	98.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	94.5 percentage of SpO2 Standard Deviation 0.71
Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at 24 Hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Baseline: Oxygen Received at Some Point During Study	—	91.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	95.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—
Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at 24 Hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Baseline: Oxygen Never Received	93.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—	—	—
Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at 24 Hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Change from Baseline: End of Treatment: Oxygen Received Throughout:	3.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	5.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	0.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	-0.5 percentage of SpO2 Standard Deviation 0.71
Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at 24 Hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Change from Baseline: End of Treatment: Oxygen Received at Some Point During Study	—	5.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	-4.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—
Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at 24 Hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Change from Baseline: End of Treatment: Oxygen Never Received	1.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—	—	—
Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at 24 Hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Change from Baseline: Follow Up 1: Oxygen Received Throughout	3.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	1.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	0.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	0.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.
Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at 24 Hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Change from Baseline: Follow Up 1: Oxygen Received at Some Point During Study	—	5.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	1.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—
Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at 24 Hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Change from Baseline: Follow Up 1: Oxygen Never Received	1.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—	—	—
Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at 24 Hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD Change from Baseline: Follow Up 2: Oxygen Received Throughout	0.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	5.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	-5.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	-1.5 percentage of SpO2 Standard Deviation 0.71

PRIMARY outcome

Timeframe: Baseline (pre-dose Day 1); Day 2, 3, 4, 5; 120 hours (End of Treatment), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (between Day 34-41), and/or early termination (ET).

Population: All participants randomly assigned to study intervention and who take at least 1 dose of study intervention for the Part 2. Participants will be analyzed according to the product they actually received. Number of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific time point.

Percent SpO2 values at baseline and changes from baseline were summarized for participants in 3 categories: (1) participants who received supplemental oxygen throughout, (2) participants who received supplemental oxygen at some point during the study, and (3) participants who never received supplemental oxygen. Baseline of pulse oximetry/SpO2 was defined as the last pre-dose measurement.

SpO2 = arterial oxygen saturation.

Outcome measures

Measure	Part 1: PF-07304814 500 mg 24-hours Continuous Infusion n=6 Participants Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion.	Part 1: PF-07304814 250 mg 24-hours Continuous Infusion n=7 Participants Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion.	Part 1: 500 mg Placebo 24-hours Continuous Infusion n=4 Participants Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.	Part 1: 250 mg Placebo 24-hours Continuous Infusion Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.
Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at Day 2, 3, 4, 5; 6 (120hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41), and/or Early Termination-Part 2: MAD Baseline: Oxygen Received Throughout	93.3 percentage of SpO2 Standard Deviation 3.77	96.3 percentage of SpO2 Standard Deviation 0.58	60.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—
Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at Day 2, 3, 4, 5; 6 (120hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41), and/or Early Termination-Part 2: MAD Baseline: Oxygen Received at Some Point During Study	97.0 percentage of SpO2 Standard Deviation 0.00	96.0 percentage of SpO2 Standard Deviation 2.65	97.3 percentage of SpO2 Standard Deviation 0.58	—
Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at Day 2, 3, 4, 5; 6 (120hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41), and/or Early Termination-Part 2: MAD Baseline: Oxygen Never Received	—	98.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—	—
Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at Day 2, 3, 4, 5; 6 (120hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41), and/or Early Termination-Part 2: MAD Change from Baseline: Day 2: Oxygen Received Throughout	2.0 percentage of SpO2 Standard Deviation 3.74	-3.3 percentage of SpO2 Standard Deviation 2.08	34.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—
Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at Day 2, 3, 4, 5; 6 (120hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41), and/or Early Termination-Part 2: MAD Change from Baseline: Day 2: Oxygen Received at Some Point During Study	1.0 percentage of SpO2 Standard Deviation 0.00	-1.0 percentage of SpO2 Standard Deviation 1.0	-2.7 percentage of SpO2 Standard Deviation 2.08	—
Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at Day 2, 3, 4, 5; 6 (120hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41), and/or Early Termination-Part 2: MAD Change from Baseline: Day 2: Oxygen Never Received	—	2.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—	—
Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at Day 2, 3, 4, 5; 6 (120hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41), and/or Early Termination-Part 2: MAD Change from Baseline: Day 3: Oxygen Received Throughout	1.3 percentage of SpO2 Standard Deviation 3.77	-2.3 percentage of SpO2 Standard Deviation 2.08	31.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—
Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at Day 2, 3, 4, 5; 6 (120hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41), and/or Early Termination-Part 2: MAD Change from Baseline: Day 3: Oxygen Received at Some Point During Study	-2.0 percentage of SpO2 Standard Deviation 2.83	0.0 percentage of SpO2 Standard Deviation 1.00	-1.0 percentage of SpO2 Standard Deviation 1.0	—
Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at Day 2, 3, 4, 5; 6 (120hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41), and/or Early Termination-Part 2: MAD Change from Baseline: Day 3: Oxygen Never Received	—	-3.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—	—
Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at Day 2, 3, 4, 5; 6 (120hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41), and/or Early Termination-Part 2: MAD Change from Baseline: Day 4: Oxygen Received Throughout	2.0 percentage of SpO2 Standard Deviation 2.45	-0.7 percentage of SpO2 Standard Deviation 2.52	29.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—
Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at Day 2, 3, 4, 5; 6 (120hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41), and/or Early Termination-Part 2: MAD Change from Baseline: Day 4: Oxygen Received at Some Point During Study	-1.0 percentage of SpO2 Standard Deviation 0.00	-0.7 percentage of SpO2 Standard Deviation 0.58	-3.5 percentage of SpO2 Standard Deviation 2.12	—
Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at Day 2, 3, 4, 5; 6 (120hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41), and/or Early Termination-Part 2: MAD Change from Baseline: Day 4: Oxygen Never Received	—	-3.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—	—
Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at Day 2, 3, 4, 5; 6 (120hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41), and/or Early Termination-Part 2: MAD Change from Baseline: Day 5: Oxygen Received Throughout	3.0 percentage of SpO2 Standard Deviation 4.08	-1.3 percentage of SpO2 Standard Deviation 3.79	25.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—
Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at Day 2, 3, 4, 5; 6 (120hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41), and/or Early Termination-Part 2: MAD Change from Baseline: Day 5: Oxygen Received at Some Point During Study	-1.5 percentage of SpO2 Standard Deviation 0.71	-1.3 percentage of SpO2 Standard Deviation 2.08	-5.5 percentage of SpO2 Standard Deviation 3.54	—
Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at Day 2, 3, 4, 5; 6 (120hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41), and/or Early Termination-Part 2: MAD Change from Baseline: Day 5: Oxygen Never Received	—	-2.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—	—
Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at Day 2, 3, 4, 5; 6 (120hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41), and/or Early Termination-Part 2: MAD Change from Baseline: End of Treatment: Oxygen Received Throughout	0.8 percentage of SpO2 Standard Deviation 3.86	-1.0 percentage of SpO2 Standard Deviation 1.73	34.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—
Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at Day 2, 3, 4, 5; 6 (120hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41), and/or Early Termination-Part 2: MAD Change from Baseline: End of Treatment: Oxygen Received at Some Point During Study	0.0 percentage of SpO2 Standard Deviation 2.83	0.3 percentage of SpO2 Standard Deviation 2.08	-5.5 percentage of SpO2 Standard Deviation 0.71	—
Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at Day 2, 3, 4, 5; 6 (120hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41), and/or Early Termination-Part 2: MAD Change from Baseline: End of Treatment: Oxygen Never Received	—	0.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—	—
Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at Day 2, 3, 4, 5; 6 (120hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41), and/or Early Termination-Part 2: MAD Change from Baseline: Early Termination: Oxygen Received at Some Point During Study	—	—	-1.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—
Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at Day 2, 3, 4, 5; 6 (120hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41), and/or Early Termination-Part 2: MAD Change from Baseline: Follow Up 1: Oxygen Received Throughout	2.0 percentage of SpO2 Standard Deviation 2.45	-1.0 percentage of SpO2 Standard Deviation 0.00	36.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—
Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at Day 2, 3, 4, 5; 6 (120hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41), and/or Early Termination-Part 2: MAD Change from Baseline: Follow Up 1: Oxygen Received at Some Point During Study	-2.5 percentage of SpO2 Standard Deviation 0.71	0.0 percentage of SpO2 Standard Deviation 1.73	-3.0 percentage of SpO2 Standard Deviation 2.83	—
Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at Day 2, 3, 4, 5; 6 (120hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41), and/or Early Termination-Part 2: MAD Change from Baseline: Follow Up 1: Oxygen Never Received	—	-1.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—	—
Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at Day 2, 3, 4, 5; 6 (120hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41), and/or Early Termination-Part 2: MAD Change from Baseline: Follow Up 2: Oxygen Received Throughout	3.3 percentage of SpO2 Standard Deviation 4.04	-2.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	31.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—
Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at Day 2, 3, 4, 5; 6 (120hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41), and/or Early Termination-Part 2: MAD Change from Baseline: Follow Up 2: Oxygen Received at Some Point During Study	-2.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—	1.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—
Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at Day 2, 3, 4, 5; 6 (120hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41), and/or Early Termination-Part 2: MAD Change from Baseline: Follow Up 3: Oxygen Received Throughout	3.7 percentage of SpO2 Standard Deviation 4.04	-2.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	31.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—
Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at Day 2, 3, 4, 5; 6 (120hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41), and/or Early Termination-Part 2: MAD Change from Baseline: Follow Up 3: Oxygen Received at Some Point During Study	0.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	2.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	0.5 percentage of SpO2 Standard Deviation 0.71	—
Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at Day 2, 3, 4, 5; 6 (120hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41), and/or Early Termination-Part 2: MAD Change from Baseline: Follow Up 4: Oxygen Received Throughout	3.0 percentage of SpO2 Standard Deviation 1.41	-0.5 percentage of SpO2 Standard Deviation 3.54	—	—
Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at Day 2, 3, 4, 5; 6 (120hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41), and/or Early Termination-Part 2: MAD Change from Baseline: Follow Up 4: Oxygen Received at Some Point During Study	—	1.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	-3.0 percentage of SpO2 Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—

PRIMARY outcome

Timeframe: Baseline (pre-dose Day 1); 30 minutes, 2 hours, 6 hour, and 12 hours (post-dose Day1); 24 hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2)

Population: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for Part 1. Participants were analyzed according to the product they received. Number of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific time point.

The average of the triplicate readings collected at each assessment time was calculated for each ECG parameter. Baseline was defined as the average (if possible) of the triplicate pre-dose recordings on Day 1. Only centrally read ECG data was used.

Outcome measures

Measure	Part 1: PF-07304814 500 mg 24-hours Continuous Infusion n=2 Participants Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion.	Part 1: PF-07304814 250 mg 24-hours Continuous Infusion n=2 Participants Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion.	Part 1: 500 mg Placebo 24-hours Continuous Infusion n=2 Participants Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.	Part 1: 250 mg Placebo 24-hours Continuous Infusion n=2 Participants Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.
Summary of Baseline and Change From Baseline in ECG Mean Heart Rate at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD ECG mean heart rate: Change from Baseline: Follow Up 2	-14.0 Beats per minute Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	1.0 Beats per minute Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	1.0 Beats per minute Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	-8.0 Beats per minute Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.
Summary of Baseline and Change From Baseline in ECG Mean Heart Rate at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD ECG mean heart rate: Baseline	87.5 Beats per minute Standard Deviation 3.54	71.5 Beats per minute Standard Deviation 4.95	66.0 Beats per minute Standard Deviation 15.56	71.0 Beats per minute Standard Deviation 7.07
Summary of Baseline and Change From Baseline in ECG Mean Heart Rate at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD ECG mean heart rate: Change from Baseline: Day 1 - 30 minutes	-3.5 Beats per minute Standard Deviation 3.54	—	-5.5 Beats per minute Standard Deviation 0.71	—
Summary of Baseline and Change From Baseline in ECG Mean Heart Rate at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD ECG mean heart rate: Change from Baseline: Day 1 - 2 hours	2.0 Beats per minute Standard Deviation 8.49	—	-4.0 Beats per minute Standard Deviation 2.83	—
Summary of Baseline and Change From Baseline in ECG Mean Heart Rate at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD ECG mean heart rate: Change from Baseline: Day 1 - 6 hours	-12.5 Beats per minute Standard Deviation 4.95	2.5 Beats per minute Standard Deviation 0.71	-13.5 Beats per minute Standard Deviation 9.19	7.5 Beats per minute Standard Deviation 13.44
Summary of Baseline and Change From Baseline in ECG Mean Heart Rate at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD ECG mean heart rate: Change from Baseline: Day 1 - 12 hours	-7.0 Beats per minute Standard Deviation 11.31	3.0 Beats per minute Standard Deviation 5.66	-9.5 Beats per minute Standard Deviation 3.54	8.5 Beats per minute Standard Deviation 10.61
Summary of Baseline and Change From Baseline in ECG Mean Heart Rate at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD ECG mean heart rate: Change from Baseline: End of Treatment	-7.0 Beats per minute Standard Deviation 5.66	-9.0 Beats per minute Standard Deviation 7.07	2.5 Beats per minute Standard Deviation 10.61	-4.0 Beats per minute Standard Deviation 2.83
Summary of Baseline and Change From Baseline in ECG Mean Heart Rate at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD ECG mean heart rate: Change from Baseline: Follow Up 1	-8.0 Beats per minute Standard Deviation 11.31	-2.0 Beats per minute Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	-3.5 Beats per minute Standard Deviation 0.71	8.0 Beats per minute Standard Deviation 5.66

PRIMARY outcome

Timeframe: Baseline (pre-dose Day 1); Day 2, 3, 5; 120 hours (End of Treatment), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (between Day 34-41), and/or early termination(ET)

Population: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for Part 2. Participants were analyzed according to the product they received. Number of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific time point.

The average of the triplicate readings collected at each assessment time was calculated for each ECG parameter. Baseline was defined as the average (if possible) of the triplicate pre-dose recordings on Day 1. Only centrally read ECG data was used.

Outcome measures

Measure	Part 1: PF-07304814 500 mg 24-hours Continuous Infusion n=6 Participants Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion.	Part 1: PF-07304814 250 mg 24-hours Continuous Infusion n=7 Participants Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion.	Part 1: 500 mg Placebo 24-hours Continuous Infusion n=4 Participants Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.	Part 1: 250 mg Placebo 24-hours Continuous Infusion Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.
Summary of Baseline and Change From Baseline in ECG Mean Heart Rate at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD ECG mean heart rate: Baseline	70.2 Beats per minute Standard Deviation 9.02	80.1 Beats per minute Standard Deviation 11.29	85.0 Beats per minute Standard Deviation 41.16	—
Summary of Baseline and Change From Baseline in ECG Mean Heart Rate at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD ECG mean heart rate: Change from Baseline: Day 2	-4.7 Beats per minute Standard Deviation 8.52	-6.0 Beats per minute Standard Deviation 18.90	-0.7 Beats per minute Standard Deviation 2.08	—
Summary of Baseline and Change From Baseline in ECG Mean Heart Rate at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD ECG mean heart rate: Change from Baseline: Day 3	-8.7 Beats per minute Standard Deviation 15.49	-12.0 Beats per minute Standard Deviation 15.01	-7.5 Beats per minute Standard Deviation 18.91	—
Summary of Baseline and Change From Baseline in ECG Mean Heart Rate at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD ECG mean heart rate: Change from Baseline: Day 5	-6.7 Beats per minute Standard Deviation 13.28	-9.0 Beats per minute Standard Deviation 8.04	-13.7 Beats per minute Standard Deviation 27.61	—
Summary of Baseline and Change From Baseline in ECG Mean Heart Rate at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD ECG mean heart rate: Change from Baseline: End of Treatment	-8.7 Beats per minute Standard Deviation 16.65	-8.4 Beats per minute Standard Deviation 13.46	-15.0 Beats per minute Standard Deviation 42.79	—
Summary of Baseline and Change From Baseline in ECG Mean Heart Rate at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD ECG mean heart rate: Change from Baseline: Early Termination	—	—	9.0 Beats per minute Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—
Summary of Baseline and Change From Baseline in ECG Mean Heart Rate at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD ECG mean heart rate: Change from Baseline: Follow Up 1	2.8 Beats per minute Standard Deviation 17.73	-6.9 Beats per minute Standard Deviation 8.63	21.0 Beats per minute Standard Deviation 10.44	—
Summary of Baseline and Change From Baseline in ECG Mean Heart Rate at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD ECG mean heart rate: Change from Baseline: Follow Up 2	7.0 Beats per minute Standard Deviation 12.68	-26.0 Beats per minute Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	2.0 Beats per minute Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—
Summary of Baseline and Change From Baseline in ECG Mean Heart Rate at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD ECG mean heart rate: Change from Baseline: Follow Up 3	8.5 Beats per minute Standard Deviation 12.07	-12.5 Beats per minute Standard Deviation 16.26	6.0 Beats per minute Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—
Summary of Baseline and Change From Baseline in ECG Mean Heart Rate at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD ECG mean heart rate: Change from Baseline: Follow Up 4	-6.0 Beats per minute Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	8.0 Beats per minute Standard Deviation 21.38	21.0 Beats per minute Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—

PRIMARY outcome

Timeframe: Baseline (pre-dose Day 1); 30 minutes, 2 hours, 6 hour, and 12 hours (post-dose Day1); 24 hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2)

Population: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for Part 1. Participants were analyzed according to the product they received. Number of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific time point.

The average of the triplicate readings collected at each assessment time was calculated for each ECG parameter. Baseline was defined as the average (if possible) of the triplicate pre-dose recordings on Day 1. Only centrally read ECG data was used.

Outcome measures

Measure	Part 1: PF-07304814 500 mg 24-hours Continuous Infusion n=2 Participants Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion.	Part 1: PF-07304814 250 mg 24-hours Continuous Infusion n=2 Participants Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion.	Part 1: 500 mg Placebo 24-hours Continuous Infusion n=2 Participants Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.	Part 1: 250 mg Placebo 24-hours Continuous Infusion n=2 Participants Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD PR interval: Change from Baseline: Day 1 - 30 minutes	-7.0 Millisecond Standard Deviation 1.41	—	-1.5 Millisecond Standard Deviation 0.71	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD PR interval: Change from Baseline: Day 1 - 2 hours	-6.0 Millisecond Standard Deviation 14.14	—	-2.5 Millisecond Standard Deviation 2.12	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD PR interval: Change from Baseline: Day 1 - 6 hours	-3.5 Millisecond Standard Deviation 4.95	-1.5 Millisecond Standard Deviation 7.78	-2.5 Millisecond Standard Deviation 4.95	-14.5 Millisecond Standard Deviation 4.95
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD PR interval: Change from Baseline: Day 1 - 12 hours	-4.0 Millisecond Standard Deviation 11.31	-11.0 Millisecond Standard Deviation 19.80	0.5 Millisecond Standard Deviation 3.54	-19.5 Millisecond Standard Deviation 4.95
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD PR interval: Change from Baseline: End of Treatment	-8.0 Millisecond Standard Deviation 2.83	1.5 Millisecond Standard Deviation 10.61	-7.5 Millisecond Standard Deviation 6.36	-7.0 Millisecond Standard Deviation 5.66
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD PR interval: Change from Baseline: Follow Up 1	-3.5 Millisecond Standard Deviation 12.02	5.0 Millisecond Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	-2.0 Millisecond Standard Deviation 12.73	-16.5 Millisecond Standard Deviation 6.36
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD PR interval: Change from Baseline: Follow Up 2	9.0 Millisecond Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	-1.0 Millisecond Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	-7.0 Millisecond Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	-11.0 Millisecond Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD QRS interval: Baseline	92.5 Millisecond Standard Deviation 2.12	99.0 Millisecond Standard Deviation 4.24	95.0 Millisecond Standard Deviation 8.49	103.0 Millisecond Standard Deviation 4.24
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD QRS interval: Change from Baseline: Day 1 - 30 minutes	-2.0 Millisecond Standard Deviation 5.66	—	1.0 Millisecond Standard Deviation 2.83	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD QRS interval: Change from Baseline: Day 1 - 2 hours	-2.5 Millisecond Standard Deviation 0.71	—	1.0 Millisecond Standard Deviation 1.41	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD QRS interval: Change from Baseline: Day 1 - 6 hours	-2.5 Millisecond Standard Deviation 2.12	-3.0 Millisecond Standard Deviation 12.73	-2.0 Millisecond Standard Deviation 2.83	0.0 Millisecond Standard Deviation 1.41
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD QRS interval: Change from Baseline: Day 1 - 12 hours	-2.5 Millisecond Standard Deviation 0.71	0.0 Millisecond Standard Deviation 5.66	-3.0 Millisecond Standard Deviation 0.00	-0.5 Millisecond Standard Deviation 3.54
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD QRS interval: Change from Baseline: End of Treatment	1.5 Millisecond Standard Deviation 6.36	0.0 Millisecond Standard Deviation 1.41	0.0 Millisecond Standard Deviation 4.24	0.5 Millisecond Standard Deviation 0.71
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD QRS interval: Change from Baseline: Follow Up 1	1.0 Millisecond Standard Deviation 0.00	-1.0 Millisecond Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	-5.0 Millisecond Standard Deviation 1.41	0.0 Millisecond Standard Deviation 2.83
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD QRS interval: Change from Baseline: Follow Up 2	-1.0 Millisecond Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	-2.0 Millisecond Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	2.0 Millisecond Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	1.0 Millisecond Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD QT interval: Baseline	348.5 Millisecond Standard Deviation 30.41	401.0 Millisecond Standard Deviation 48.08	397.5 Millisecond Standard Deviation 30.41	389.0 Millisecond Standard Deviation 22.63
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD QT interval: Change from Baseline: Day 1 - 30 minutes	5.5 Millisecond Standard Deviation 21.92	—	1.0 Millisecond Standard Deviation 12.73	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD QT interval: Change from Baseline: Day 1 - 2 hours	-3.5 Millisecond Standard Deviation 12.02	—	-1.0 Millisecond Standard Deviation 14.14	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD QT interval: Change from Baseline: Day 1 - 6 hours	24.5 Millisecond Standard Deviation 10.61	-16.5 Millisecond Standard Deviation 24.75	19.5 Millisecond Standard Deviation 38.89	-13.5 Millisecond Standard Deviation 28.99
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD QT interval: Change from Baseline: Day 1 - 12 hours	28.5 Millisecond Standard Deviation 30.41	-1.0 Millisecond Standard Deviation 1.41	30.0 Millisecond Standard Deviation 19.80	-20.0 Millisecond Standard Deviation 28.28
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD QT interval: Change from Baseline: End of Treatment	28.0 Millisecond Standard Deviation 16.97	28.5 Millisecond Standard Deviation 36.06	-6.5 Millisecond Standard Deviation 37.48	15.0 Millisecond Standard Deviation 11.31
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD QT interval: Change from Baseline: Follow Up 1	28.5 Millisecond Standard Deviation 26.16	2.0 Millisecond Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	-12.0 Millisecond Standard Deviation 15.56	-8.5 Millisecond Standard Deviation 2.12
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD QT interval: Change from Baseline: Follow Up 2	38.0 Millisecond Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	-13.0 Millisecond Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	-23.0 Millisecond Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	38.0 Millisecond Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD QTcF: Baseline	395.0 Millisecond Standard Deviation 28.28	423.0 Millisecond Standard Deviation 41.01	408.0 Millisecond Standard Deviation 1.41	411.5 Millisecond Standard Deviation 10.61
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD QTcF: Change from Baseline: Day 1 - 30 minutes	-1.0 Millisecond Standard Deviation 19.80	—	-10.0 Millisecond Standard Deviation 14.14	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD QTcF: Change from Baseline: Day 1 - 2 hours	-2.0 Millisecond Standard Deviation 2.83	—	-8.5 Millisecond Standard Deviation 9.19	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD QTcF: Change from Baseline: Day 1 - 6 hours	7.0 Millisecond Standard Deviation 16.97	-10.5 Millisecond Standard Deviation 23.33	-9.5 Millisecond Standard Deviation 21.92	-1.0 Millisecond Standard Deviation 7.07
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD QTcF: Change from Baseline: Day 1 - 12 hours	17.5 Millisecond Standard Deviation 12.02	5.0 Millisecond Standard Deviation 7.07	9.5 Millisecond Standard Deviation 17.68	-6.0 Millisecond Standard Deviation 9.90
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD QTcF: Change from Baseline: End of Treatment	18.5 Millisecond Standard Deviation 7.78	9.0 Millisecond Standard Deviation 14.14	0.5 Millisecond Standard Deviation 16.26	6.5 Millisecond Standard Deviation 6.36
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD QTcF: Change from Baseline: Follow Up 1	16.0 Millisecond Standard Deviation 8.49	1.0 Millisecond Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	-19.0 Millisecond Standard Deviation 15.56	6.0 Millisecond Standard Deviation 9.90
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD QTcF: Change from Baseline: Follow Up 2	18.0 Millisecond Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	-12.0 Millisecond Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	-21.0 Millisecond Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	24.0 Millisecond Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD PR interval: Baseline	153.0 Millisecond Standard Deviation 5.66	165.0 Millisecond Standard Deviation 29.70	171.0 Millisecond Standard Deviation 16.97	183.5 Millisecond Standard Deviation 10.61

PRIMARY outcome

Timeframe: Baseline (pre-dose Day 1); Day 2, 3, 5; 120 hours (End of Treatment), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (between Day 34-41), and/or early termination(ET)

Population: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention for Part 2. Participants were analyzed according to the product they received. Number of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at the specific time point.

The average of the triplicate readings collected at each assessment time was calculated for each ECG parameter. Baseline was defined as the average (if possible) of the triplicate pre-dose recordings on Day 1. Only centrally read ECG data was used.

Outcome measures

Measure	Part 1: PF-07304814 500 mg 24-hours Continuous Infusion n=6 Participants Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion.	Part 1: PF-07304814 250 mg 24-hours Continuous Infusion n=7 Participants Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion.	Part 1: 500 mg Placebo 24-hours Continuous Infusion n=4 Participants Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.	Part 1: 250 mg Placebo 24-hours Continuous Infusion Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD PR interval: Baseline	145.7 Millisecond Standard Deviation 12.86	139.7 Millisecond Standard Deviation 19.14	156.0 Millisecond Standard Deviation 28.31	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD PR interval: Change from Baseline: Day 2	3.8 Millisecond Standard Deviation 14.76	-5.0 Millisecond Standard Deviation 15.17	1.3 Millisecond Standard Deviation 4.51	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD PR interval: Change from Baseline: Day 3	1.2 Millisecond Standard Deviation 17.88	-3.2 Millisecond Standard Deviation 9.91	6.0 Millisecond Standard Deviation 11.36	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD PR interval: Change from Baseline: Day 5	5.7 Millisecond Standard Deviation 19.81	-1.6 Millisecond Standard Deviation 13.50	-3.0 Millisecond Standard Deviation 14.14	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD PR interval: Change from Baseline: End of Treatment	9.3 Millisecond Standard Deviation 15.46	-0.6 Millisecond Standard Deviation 15.82	-0.3 Millisecond Standard Deviation 7.64	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD PR interval: Change from Baseline: Early Termination	—	—	-1.0 Millisecond Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD PR interval: Change from Baseline: Follow Up 1	7.2 Millisecond Standard Deviation 18.63	1.4 Millisecond Standard Deviation 17.86	-8.0 Millisecond Standard Deviation 18.36	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD PR interval: Change from Baseline: Follow Up 2	6.8 Millisecond Standard Deviation 28.85	-30.0 Millisecond Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	-6.0 Millisecond Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD PR interval: Change from Baseline: Follow Up 3	12.0 Millisecond Standard Deviation 24.45	-21.0 Millisecond Standard Deviation 31.11	-18.0 Millisecond Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD PR interval: Change from Baseline: Follow Up 4	15.0 Millisecond Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	-4.0 Millisecond Standard Deviation 19.31	-23.0 Millisecond Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD QRS interval: Baseline	93.7 Millisecond Standard Deviation 4.68	93.6 Millisecond Standard Deviation 10.63	90.5 Millisecond Standard Deviation 4.43	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD QRS interval: Change from Baseline: Day 2	6.7 Millisecond Standard Deviation 7.94	1.7 Millisecond Standard Deviation 5.09	4.7 Millisecond Standard Deviation 7.09	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD QRS interval: Change from Baseline: Day 3	-0.7 Millisecond Standard Deviation 3.08	3.5 Millisecond Standard Deviation 5.32	3.3 Millisecond Standard Deviation 3.30	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD QRS interval: Change from Baseline: Day 5	0.7 Millisecond Standard Deviation 2.88	3.0 Millisecond Standard Deviation 3.92	7.0 Millisecond Standard Deviation 5.29	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD QRS interval: Change from Baseline: End of Treatment	0.3 Millisecond Standard Deviation 3.78	5.6 Millisecond Standard Deviation 5.56	2.3 Millisecond Standard Deviation 3.51	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD QRS interval: Change from Baseline: Early Termination	—	—	-3.0 Millisecond Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD QRS interval: Change from Baseline: Follow Up 1	1.0 Millisecond Standard Deviation 4.18	4.0 Millisecond Standard Deviation 6.43	2.3 Millisecond Standard Deviation 6.35	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD QRS interval: Change from Baseline: Follow Up 2	2.3 Millisecond Standard Deviation 4.50	16.0 Millisecond Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	8.0 Millisecond Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD QRS interval: Change from Baseline: Follow Up 3	-0.3 Millisecond Standard Deviation 4.86	6.0 Millisecond Standard Deviation 5.66	15.0 Millisecond Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD QRS interval: Change from Baseline: Follow Up 4	-12.0 Millisecond Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	7.0 Millisecond Standard Deviation 3.61	5.0 Millisecond Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD QT interval: Baseline	385.5 Millisecond Standard Deviation 24.74	366.1 Millisecond Standard Deviation 22.17	373.8 Millisecond Standard Deviation 59.57	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD QT interval: Change from Baseline: Day 2	25.3 Millisecond Standard Deviation 35.59	16.2 Millisecond Standard Deviation 48.16	8.3 Millisecond Standard Deviation 9.07	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD QT interval: Change from Baseline: Day 3	27.5 Millisecond Standard Deviation 59.06	27.3 Millisecond Standard Deviation 43.01	10.0 Millisecond Standard Deviation 37.34	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD QT interval: Change from Baseline: Day 5	12.5 Millisecond Standard Deviation 31.04	29.0 Millisecond Standard Deviation 21.57	28.0 Millisecond Standard Deviation 61.54	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD QT interval: Change from Baseline: End of Treatment	21.8 Millisecond Standard Deviation 46.10	23.3 Millisecond Standard Deviation 31.07	8.0 Millisecond Standard Deviation 60.61	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD QT interval: Change from Baseline: Early Termination	—	—	-17.0 Millisecond Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD QT interval: Change from Baseline: Follow Up 1	-10.2 Millisecond Standard Deviation 39.09	20.9 Millisecond Standard Deviation 16.82	-49.7 Millisecond Standard Deviation 32.59	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD QT interval: Change from Baseline: Follow Up 2	-19.3 Millisecond Standard Deviation 27.00	63.0 Millisecond Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	0.0 Millisecond Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD QT interval: Change from Baseline: Follow Up 3	-22.0 Millisecond Standard Deviation 22.17	24.5 Millisecond Standard Deviation 13.44	-21.0 Millisecond Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD QT interval: Change from Baseline: Follow Up 4	5.0 Millisecond Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	-4.0 Millisecond Standard Deviation 39.36	-36.0 Millisecond Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD QTcF: Baseline	404.7 Millisecond Standard Deviation 18.13	401.3 Millisecond Standard Deviation 10.44	405.3 Millisecond Standard Deviation 18.84	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD QTcF: Change from Baseline: Day 2	17.5 Millisecond Standard Deviation 20.96	6.8 Millisecond Standard Deviation 19.75	9.0 Millisecond Standard Deviation 7.94	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD QTcF: Change from Baseline: Day 3	8.3 Millisecond Standard Deviation 27.66	8.0 Millisecond Standard Deviation 21.80	7.5 Millisecond Standard Deviation 24.19	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD QTcF: Change from Baseline: Day 5	-0.2 Millisecond Standard Deviation 11.82	16.4 Millisecond Standard Deviation 20.74	19.7 Millisecond Standard Deviation 39.37	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD QTcF: Change from Baseline: End of Treatment	3.7 Millisecond Standard Deviation 16.50	10.7 Millisecond Standard Deviation 17.93	-1.3 Millisecond Standard Deviation 15.50	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD QTcF: Change from Baseline: Early Termination	—	—	-1.0 Millisecond Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD QTcF: Change from Baseline: Follow Up 1	-7.2 Millisecond Standard Deviation 9.09	9.1 Millisecond Standard Deviation 18.43	-15.7 Millisecond Standard Deviation 23.01	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD QTcF: Change from Baseline: Follow Up 2	-5.8 Millisecond Standard Deviation 9.00	18.0 Millisecond Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	9.0 Millisecond Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD QTcF: Change from Baseline: Follow Up 3	-7.3 Millisecond Standard Deviation 9.54	4.5 Millisecond Standard Deviation 13.44	-7.0 Millisecond Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD QTcF: Change from Baseline: Follow Up 4	-6.0 Millisecond Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	2.3 Millisecond Standard Deviation 19.43	7.0 Millisecond Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	—

SECONDARY outcome

Timeframe: Pre-dose and 6 hours post-dose on Day 1; 24 hours; 48 hours; and/or early termination.

Population: All participants randomly assigned to study intervention and who take at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest are reported for Part 1: SAD. Number of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at different parameters.

C24 was defined as concentration at 24 hours. 24-hour PK draw was approximately 4 hours post end of infusion which corresponded to 28 hours.

Outcome measures

Measure	Part 1: PF-07304814 500 mg 24-hours Continuous Infusion n=1 Participants Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion.	Part 1: PF-07304814 250 mg 24-hours Continuous Infusion n=2 Participants Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion.	Part 1: 500 mg Placebo 24-hours Continuous Infusion Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.	Part 1: 250 mg Placebo 24-hours Continuous Infusion Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.
PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameters: Concentration at 24 Hours (End of Infusion) - Part 1: SAD C24 of PF-07304814	NA ng/mL Geometric Coefficient of Variation NA Geometric mean and CV is not applicable with n=1.	NA ng/mL Geometric Coefficient of Variation NA Geometric mean and CV is not applicable due to n\<3.	—	—
PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameters: Concentration at 24 Hours (End of Infusion) - Part 1: SAD C24 of PF-00835231	NA ng/mL Geometric Coefficient of Variation NA Geometric mean and CV is not applicable with n=1.	NA ng/mL Geometric Coefficient of Variation NA Geometric mean and CV is not applicable due to n\<3.	—	—

SECONDARY outcome

Timeframe: Pre-dose on Day1; Day 2, 3, 5 and 6 (end of treatment day), 7 (Follow-up 1), and/or early termination.

Population: All participants randomly assigned to study intervention and who take at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest are reported for Part 2: MAD. Number of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at different parameters.

C120 was defined as concentration at 120 hours. Blood sample collection at approximately at 2 and 6 hours post the end of the infusion, which correspond to approximately 122 hours and 126 hours post the start of infusion.

Outcome measures

Measure	Part 1: PF-07304814 500 mg 24-hours Continuous Infusion n=6 Participants Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion.	Part 1: PF-07304814 250 mg 24-hours Continuous Infusion n=7 Participants Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion.	Part 1: 500 mg Placebo 24-hours Continuous Infusion Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.	Part 1: 250 mg Placebo 24-hours Continuous Infusion Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.
PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameter: Concentration at 120 Hours (End of Infusion) - Part 2: MAD C120 of PF-07304814	197.2 ng/mL Geometric Coefficient of Variation 72	91.64 ng/mL Geometric Coefficient of Variation 51	—	—
PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameter: Concentration at 120 Hours (End of Infusion) - Part 2: MAD C120 of PF-00835231	1338 ng/mL Geometric Coefficient of Variation 84	800.8 ng/mL Geometric Coefficient of Variation 19	—	—

SECONDARY outcome

Timeframe: Pre-dose on Day1; Day 2, 3, 5 and 6 (end of treatment day), 7 (Follow-up 1), and/or early termination.

Population: All participants randomly assigned to study intervention and who take at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest are reported for Part 2: MAD. Number of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at different parameters.

Cmax was defined as maximum observed concentration. Blood sample collection at approximately 2 and 6 hours post the end of the infusion, which correspond to approximately 122 hours and 126 hours post the start of infusion.

Outcome measures

Measure	Part 1: PF-07304814 500 mg 24-hours Continuous Infusion n=6 Participants Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion.	Part 1: PF-07304814 250 mg 24-hours Continuous Infusion n=7 Participants Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion.	Part 1: 500 mg Placebo 24-hours Continuous Infusion Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.	Part 1: 250 mg Placebo 24-hours Continuous Infusion Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.
PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameters: Maximum Observed Concentration (Cmax) - Part 2: MAD Cmax of PF-07304814	345.3 ng/mL Geometric Coefficient of Variation 70	272.6 ng/mL Geometric Coefficient of Variation 281	—	—
PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameters: Maximum Observed Concentration (Cmax) - Part 2: MAD Cmax of PF-00835231	2382 ng/mL Geometric Coefficient of Variation 36	1265 ng/mL Geometric Coefficient of Variation 20	—	—

SECONDARY outcome

Timeframe: Pre-dose on Day1; Day 2, 3, 5 and 6 (end of treatment day), 7 (Follow-up 1), and/or early termination.

Population: All participants randomly assigned to study intervention and who take at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest are reported for Part 2: MAD. Number of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at different parameters.

t½ was defined as terminal half-life. Blood sample collection at approximately within 30 minutes before end of infusion (~120 hours), and at 2 and 6 hours post the end of the infusion, which correspond to approximately 122h and 126h post the start of infusion.

Outcome measures

Measure	Part 1: PF-07304814 500 mg 24-hours Continuous Infusion n=6 Participants Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion.	Part 1: PF-07304814 250 mg 24-hours Continuous Infusion n=7 Participants Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion.	Part 1: 500 mg Placebo 24-hours Continuous Infusion Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.	Part 1: 250 mg Placebo 24-hours Continuous Infusion Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.
PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameters: t½ - Part 2: MAD t½ of PF-00835231	1.79 hour Standard Deviation NA Standard deviation was not applicable because only 1 participant was analyzed.	2.317 hour Standard Deviation 0.96547	—	—

SECONDARY outcome

Timeframe: Pre-dose on Day1; Day 2, 3, 5 and 6 (end of treatment day), 7 (Follow-up 1), and/or early termination.

Population: All participants randomly assigned to study intervention and who take at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest are reported for Part 2: MAD. Number of Participants analyzed refers to number of participants evaluable for this OM; Number Analyzed refers to number of participants evaluable at different parameters.

Css was defined as concentration at steady state. Blood sample collection at approximately 2 and 6 hours post the end of the infusion, which correspond to approximately 122 hours and 126 hours post the start of infusion.

Outcome measures

Measure	Part 1: PF-07304814 500 mg 24-hours Continuous Infusion n=6 Participants Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion.	Part 1: PF-07304814 250 mg 24-hours Continuous Infusion n=7 Participants Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion.	Part 1: 500 mg Placebo 24-hours Continuous Infusion Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.	Part 1: 250 mg Placebo 24-hours Continuous Infusion Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.
PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameters: Concentration at Steady State (Css) - Part 2: MAD Css of PF-07304814	229.2 ng/mL Geometric Coefficient of Variation 61	102.2 ng/mL Geometric Coefficient of Variation 35	—	—
PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameters: Concentration at Steady State (Css) - Part 2: MAD Css of PF-00835231	1720 ng/mL Geometric Coefficient of Variation 44	970.2 ng/mL Geometric Coefficient of Variation 16	—	—

Adverse Events

Part 1: PF-07304814 500 mg 24-hours Continuous Infusion

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 1: PF-07304814 250 mg 24-hours Continuous Infusion

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part 1: 500 mg Placebo 24-hours Continuous Infusion

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 1: 250 mg Placebo 24-hours Continuous Infusion

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 2: PF-07304814 500 mg 120-hours Continuous Infusion

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Part 2: PF-07304814 250 mg 120-hours Continuous Infusion

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Part 2: Placebo 120-hours Continuous Infusion

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Serious adverse events

Measure	Part 1: PF-07304814 500 mg 24-hours Continuous Infusion n=2 participants at risk Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion.	Part 1: PF-07304814 250 mg 24-hours Continuous Infusion n=2 participants at risk Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion.	Part 1: 500 mg Placebo 24-hours Continuous Infusion n=2 participants at risk Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.	Part 1: 250 mg Placebo 24-hours Continuous Infusion n=2 participants at risk Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.	Part 2: PF-07304814 500 mg 120-hours Continuous Infusion n=6 participants at risk Participants were enrolled in this arm and received PF-07304814 500 mg daily as 5-day (\~120 hours) continuous intravenous infusion.	Part 2: PF-07304814 250 mg 120-hours Continuous Infusion n=7 participants at risk Participants were enrolled in this arm and received PF-07304814 250 mg daily as 5-day (\~120 hours) continuous intravenous infusion.	Part 2: Placebo 120-hours Continuous Infusion n=4 participants at risk Participants were enrolled in this arm and received placebo as 5-day (\~120 hours) continuous intravenous infusion.
Infections and infestations Pneumonia	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/6 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	14.3% 1/7 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/4 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations COVID-19 pneumonia	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	50.0% 1/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/6 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/7 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/4 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/6 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	14.3% 1/7 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/4 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/6 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	14.3% 1/7 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/4 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/6 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/7 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	25.0% 1/4 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	16.7% 1/6 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/7 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	25.0% 1/4 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Vascular disorders Subclavian vein thrombosis	50.0% 1/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	50.0% 1/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/6 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/7 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/4 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.

Other adverse events

Measure	Part 1: PF-07304814 500 mg 24-hours Continuous Infusion n=2 participants at risk Participants were enrolled in this arm and received PF-07304814 500 mg as 24-hour continuous intravenous infusion.	Part 1: PF-07304814 250 mg 24-hours Continuous Infusion n=2 participants at risk Participants were enrolled in this arm and received PF-07304814 250 mg as 24-hour continuous intravenous infusion.	Part 1: 500 mg Placebo 24-hours Continuous Infusion n=2 participants at risk Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.	Part 1: 250 mg Placebo 24-hours Continuous Infusion n=2 participants at risk Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion.	Part 2: PF-07304814 500 mg 120-hours Continuous Infusion n=6 participants at risk Participants were enrolled in this arm and received PF-07304814 500 mg daily as 5-day (\~120 hours) continuous intravenous infusion.	Part 2: PF-07304814 250 mg 120-hours Continuous Infusion n=7 participants at risk Participants were enrolled in this arm and received PF-07304814 250 mg daily as 5-day (\~120 hours) continuous intravenous infusion.	Part 2: Placebo 120-hours Continuous Infusion n=4 participants at risk Participants were enrolled in this arm and received placebo as 5-day (\~120 hours) continuous intravenous infusion.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	50.0% 1/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/6 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/7 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/4 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/6 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	14.3% 1/7 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/4 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Cardiac disorders Tachycardia	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	50.0% 1/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/6 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/7 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/4 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Cardiac disorders Bradycardia	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/6 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	14.3% 1/7 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/4 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Ear and labyrinth disorders Tympanic membrane perforation	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/6 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	14.3% 1/7 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/4 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Abdominal pain	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	50.0% 1/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/6 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/7 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/4 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/6 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	14.3% 1/7 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/4 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Diarrhoea	50.0% 1/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	50.0% 1/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/6 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/7 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/4 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Gastrointestinal disorders Dyspepsia	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	50.0% 1/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/6 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/7 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/4 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Oedema	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	50.0% 1/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/6 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/7 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/4 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Oedema peripheral	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	16.7% 1/6 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/7 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/4 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Discomfort	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/6 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	14.3% 1/7 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/4 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Inflammation	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/6 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/7 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	25.0% 1/4 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Infusion site extravasation	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	16.7% 1/6 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/7 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/4 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
General disorders Non-cardiac chest pain	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	16.7% 1/6 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/7 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/4 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Folliculitis	50.0% 1/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/6 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/7 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/4 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Tinea cruris	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	50.0% 1/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/6 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/7 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/4 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Bronchitis bacterial	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/6 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/7 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	25.0% 1/4 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations COVID-19 pneumonia	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/6 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/7 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	25.0% 1/4 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Infections and infestations Stoma site cellulitis	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/6 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	14.3% 1/7 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/4 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Injury, poisoning and procedural complications Fall	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/6 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/7 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	25.0% 1/4 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Haematocrit decreased	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	50.0% 1/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/6 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/7 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/4 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Haemoglobin decreased	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	50.0% 1/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/6 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/7 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/4 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Liver function test increased	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	50.0% 1/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/6 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/7 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	25.0% 1/4 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Transaminases increased	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	50.0% 1/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/6 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/7 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/4 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Investigations Fibrin D dimer increased	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/6 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/7 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	25.0% 1/4 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/6 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	14.3% 1/7 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/4 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	50.0% 1/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/6 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/7 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/4 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/6 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/7 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	25.0% 1/4 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Renal and urinary disorders Haematuria	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	50.0% 1/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/6 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/7 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/4 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Renal and urinary disorders Oliguria	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/6 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	14.3% 1/7 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/4 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	50.0% 1/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/6 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/7 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/4 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/6 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	14.3% 1/7 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/4 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
Skin and subcutaneous tissue disorders Rash	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/2 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/6 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	14.3% 1/7 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.	0.00% 0/4 • From pre-dose on Day 1 up to 41 days The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.

Additional Information

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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