Viral Disease
Conditions
Keywords
COVID-19, SARS-COV-2
Brief summary
It is Phase 1b, 2-part, double-blind, placebo-controlled study to evaluate safety, tolerability, and pharmacokinetics of PF-07304814, in patients hospitalized with SARS-CoV-2 virus infection.
Detailed description
It is a 2-part study in hospitalized COVID-19 patients. * Part 1 is to evaluate safety, tolerability, PK and markers of clinical activity of escalating doses of PF-07304814 given as 24-hour IV infusion. 2 planned and 3 optional cohorts with 8 participants each are planned. * Part 2 is to evaluate safety, tolerability, PK and markers of clinical activity of escalating doses of PF- 07304814 given as 120-hour infusion. 2 planned and 2 optional cohorts with 8 participants each are planned
Interventions
DRUGPF-07304814
PF-07304814 is an anti-viral, formulated for intravenous delivery
DRUGPlacebo
Placebo will be formulated for intravenous delivery
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Part 1 will have 2 planned cohorts. Each escalating cohort will be initiated for enrollment after assessment of safety, tolerability and PK data from previous cohorts by an independent IRC and is deemed acceptable. Part 2 will have 2 planned cohort and each escalating cohort will be initiated after all safety, tolerability and PK data from previous cohort is evaluated and is deemed acceptable by a competent regulatory authority.
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Inclusion Criteria: 1. Male or female participants between the ages of 18 and 79 years. 2. Confirmed SARS-CoV-2 infection. 3. Hospitalized for COVID-19. 4. Symptoms consistent with COVID-19 indicated by at least 1 of the following: fever, cough, sore throat, malaise, headache, muscle pain, shortness of breath, new loss of taste and smell, nausea, chills, fatigue, rhinorrhea, diarrhea, vomiting or radiographic infiltrates by imaging consistent with COVID-19 5. Total body weight \>=50 kg (110 lb), BMI \<40 kg/m2; BMI \<35 kg/m2 for 76- 79 years. *
Exclusion criteria
1. Evidence of critical illness, defined by at least one of the following: Respiratory failure, Multi-organ dysfunction/failure, Cardiac failure or septic shock 2. Participants that are anticipated by the study Investigator to progress to critical disease, including mechanical ventilation, within 24 hours of enrolment 3. Participants with pre-existing moderate to severe cardiovascular disease, uncontrolled diabetes, or severe asthma or severe COPD. 3.Participants with a known medical history of recent acute or chronic liver disease (other than NASH), chronic or active hepatitis B or C infection, or primary biliary cirrhosis. 4.Participants with a known medical history of ischemic heart disease, heart failure, dysrhythmia or other pre-existing cardiac condition. 5\. Participants with known HIV infection, acute or chronic history of hepatitis B or C. 6.Participants with a known medical history of recurrent seizures. 7. Participants with history of venous thromboembolic event, including deep venous thrombosis or pulmonary embolism 8.Confirmed concurrent active systemic infection other than COVID-19. 9.Current diagnosis of cancer, unless in remission and untreated. 10.Other medical or psychiatric condition including recent or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation 11.Females who are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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) | 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. |
| 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 (pre-dose Day 1); Day1-24 hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) | 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. |
| 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 (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). | 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. |
| 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 | 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) | 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. |
| 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 | 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) | 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. |
| 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 | 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) | 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. |
| Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 1: SAD | Day 1 to 37 days | 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. |
| Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 2: MAD | Day 1 to 41 days | 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. |
| Number of Participants With Discontinuations From Study/Study Drug or Dose Reduction Due to TEAEs - Part 1: SAD | Day 1 up to 37 days | 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. |
| Number of Participants With Discontinuations From Study/Study Drug or Dose Reduction Due to TEAEs - Part 2: MAD | Day 1 to 41 days | 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. |
| Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | Day 1 up to 6 days | 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. |
| Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Day 1 up to 41 days | 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 |
| 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 | 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). | 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. |
| 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 | 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) . | 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. |
| 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 | 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). | 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. |
| 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 | 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). | 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. |
| 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 | 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). | 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. |
| 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 | 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). | 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. |
| 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 | 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). | 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. |
| 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 | 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). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameter: Concentration at 120 Hours (End of Infusion) - Part 2: MAD | Pre-dose on Day1; Day 2, 3, 5 and 6 (end of treatment day), 7 (Follow-up 1), and/or early termination. | 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. |
| PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameters: Maximum Observed Concentration (Cmax) - Part 2: MAD | Pre-dose on Day1; Day 2, 3, 5 and 6 (end of treatment day), 7 (Follow-up 1), and/or early termination. | 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. |
| PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameters: t½ - Part 2: MAD | Pre-dose on Day1; Day 2, 3, 5 and 6 (end of treatment day), 7 (Follow-up 1), and/or early termination. | 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. |
| PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameters: Concentration at Steady State (Css) - Part 2: MAD | Pre-dose on Day1; Day 2, 3, 5 and 6 (end of treatment day), 7 (Follow-up 1), and/or early termination. | 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. |
| PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameters: Concentration at 24 Hours (End of Infusion) - Part 1: SAD | Pre-dose and 6 hours post-dose on Day 1; 24 hours; 48 hours; and/or early termination. | 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. |
Countries
Belgium, Brazil, Spain, United States
Participant flow
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 2 |
| 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. | 2 |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion. | 2 |
| Part 1: 250 mg Placebo 24-hours Continuous Infusion Participants were enrolled in this arm and received placebo as 24-hour continuous intravenous infusion. | 2 |
| 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. | 6 |
| 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. | 7 |
| Part 2: Placebo 120-hours Continuous Infusion Participants were enrolled in this arm and received placebo as 5-day (\
120 hours) continuous intravenous infusion. | 4 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Follow-Up | Death | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Follow-Up | Lost to Follow-up | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Treatment | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Part 1: 500 mg Placebo 24-hours Continuous Infusion | Part 1: 250 mg Placebo 24-hours Continuous Infusion | Part 2: PF-07304814 500 mg 120-hours Continuous Infusion | Part 2: PF-07304814 250 mg 120-hours Continuous Infusion | Part 2: Placebo 120-hours Continuous Infusion | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 2 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 2 Participants | 2 Participants | 1 Participants | 5 Participants | 5 Participants | 2 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants | 2 Participants | 4 Participants | 5 Participants | 3 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) White | 2 Participants | 1 Participants | 1 Participants | 2 Participants | 5 Participants | 5 Participants | 3 Participants | 19 Participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 0 Participants | 6 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 4 Participants | 6 Participants | 4 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 2 | 0 / 2 | 0 / 2 | 0 / 6 | 0 / 7 | 1 / 4 |
| other Total, other adverse events | 1 / 2 | 1 / 2 | 2 / 2 | 2 / 2 | 2 / 6 | 3 / 7 | 3 / 4 |
| serious Total, serious adverse events | 1 / 2 | 0 / 2 | 1 / 2 | 1 / 2 | 1 / 6 | 2 / 7 | 1 / 4 |
Outcome results
Primary
Number of Participants With Discontinuations From Study/Study Drug or Dose Reduction Due to TEAEs - Part 1: SAD
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | 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 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | 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 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | 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 |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | 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 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | 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 |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | 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 |
| Part 1: 250 mg Placebo 24-hours Continuous Infusion | 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 |
| Part 1: 250 mg Placebo 24-hours Continuous 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 |
| Part 1: 250 mg Placebo 24-hours Continuous Infusion | 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 |
Primary
Number of Participants With Discontinuations From Study/Study Drug or Dose Reduction Due to TEAEs - Part 2: MAD
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | 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 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | 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 |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | 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 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | 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 | 0 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | 1 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | 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 | 0 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | 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 |
Primary
Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | Glucose (mg/dL) > 1.5*ULN | 0 Participants |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | URINE Hemoglobin ≥ 1 | 0 Participants |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | Glucose - FASTING (mg/dL) >1.5*ULN | 1 Participants |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | Aspartate Aminotransferase (U/L) > 3.0*ULN | 0 Participants |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | URINE Glucose ≥ 1 | 1 Participants |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | URINE Erythrocytes (/HPF) ≥ 20 | 0 Participants |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | Alanine Aminotransferase (U/L) > 3.0*ULN | 0 Participants |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | Basophils (10^3/mm3) > 1.2*ULN | 0 Participants |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | Lymphocytes (10^3/mm3) < 0.8*LLN | 1 Participants |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | Calcium (mg/dL) < 0.9*LLN | 0 Participants |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | Urobilinogen ≥ 1 | 0 Participants |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | Bicarbonate (mEq/L) < 0.9*LLN | 0 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | Basophils (10^3/mm3) > 1.2*ULN | 0 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | Glucose (mg/dL) > 1.5*ULN | 1 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | URINE Erythrocytes (/HPF) ≥ 20 | 0 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | Alanine Aminotransferase (U/L) > 3.0*ULN | 1 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | Lymphocytes (10^3/mm3) < 0.8*LLN | 2 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | Glucose - FASTING (mg/dL) >1.5*ULN | 0 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | URINE Hemoglobin ≥ 1 | 0 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | URINE Glucose ≥ 1 | 0 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | Bicarbonate (mEq/L) < 0.9*LLN | 1 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | Aspartate Aminotransferase (U/L) > 3.0*ULN | 1 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | Urobilinogen ≥ 1 | 0 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | Calcium (mg/dL) < 0.9*LLN | 0 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | Urobilinogen ≥ 1 | 0 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | Lymphocytes (10^3/mm3) < 0.8*LLN | 0 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | Basophils (10^3/mm3) > 1.2*ULN | 1 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | Aspartate Aminotransferase (U/L) > 3.0*ULN | 0 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | Alanine Aminotransferase (U/L) > 3.0*ULN | 1 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | Calcium (mg/dL) < 0.9*LLN | 1 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | Bicarbonate (mEq/L) < 0.9*LLN | 1 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | Glucose (mg/dL) > 1.5*ULN | 0 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | Glucose - FASTING (mg/dL) >1.5*ULN | 2 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | URINE Glucose ≥ 1 | 0 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | URINE Hemoglobin ≥ 1 | 0 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | URINE Erythrocytes (/HPF) ≥ 20 | 0 Participants |
| Part 1: 250 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | Glucose (mg/dL) > 1.5*ULN | 2 Participants |
| Part 1: 250 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | Bicarbonate (mEq/L) < 0.9*LLN | 1 Participants |
| Part 1: 250 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | URINE Erythrocytes (/HPF) ≥ 20 | 1 Participants |
| Part 1: 250 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | URINE Hemoglobin ≥ 1 | 1 Participants |
| Part 1: 250 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | Calcium (mg/dL) < 0.9*LLN | 0 Participants |
| Part 1: 250 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | Alanine Aminotransferase (U/L) > 3.0*ULN | 0 Participants |
| Part 1: 250 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | Urobilinogen ≥ 1 | 1 Participants |
| Part 1: 250 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | Aspartate Aminotransferase (U/L) > 3.0*ULN | 1 Participants |
| Part 1: 250 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | Basophils (10^3/mm3) > 1.2*ULN | 0 Participants |
| Part 1: 250 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | Glucose - FASTING (mg/dL) >1.5*ULN | 0 Participants |
| Part 1: 250 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | Lymphocytes (10^3/mm3) < 0.8*LLN | 1 Participants |
| Part 1: 250 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD | URINE Glucose ≥ 1 | 0 Participants |
Primary
Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD
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
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Lymphocytes (10^3/mm3)<0.8x LLN | 0 Participants |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Bicarbonate (mEq/L)<0.9x LLN | 2 Participants |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Glucose (mg/dL)>1.5x ULN | 3 Participants |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Urine hemoglobin ≥ 1 | 1 Participants |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Alanine aminotransferase (U/L)>3.0*ULN | 0 Participants |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Urobilinogen≥1 | 1 Participants |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Erythrocytes (10^6/mm3)<0.8x LLN | 0 Participants |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Nitrite≥1 | 1 Participants |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Leukocyte esterase ≥ 1 | 1 Participants |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | URINE glucose≥1 | 1 Participants |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Urine erythrocytes (/HPF)≥20 | 1 Participants |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Albumin (g/dL) <0.8x LLN | 1 Participants |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Urine leukocytes (Scalar)≥20 | 0 Participants |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Protein (g/dL)<0.8x LLN | 0 Participants |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Urea nitrogen (mg/dL)>1.3x ULN | 0 Participants |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Hemoglobin (g/dL)<0.8*LLN | 0 Participants |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Ketones≥1 | 0 Participants |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | 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 |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Creatinine (mg/dL)>1.3x ULN | 0 Participants |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | HDL cholesterol (mg/dL)<0.8x LLN | 2 Participants |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Hematocrit (%)<0.8x LLN | 0 Participants |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | 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 |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Triglycerides (mg/dL)>1.3x ULN | 1 Participants |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Calcium (mg/dL)<0.9x LLN | 1 Participants |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Phosphate (mg/dL)<0.8x LLN | 0 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | URINE glucose≥1 | 1 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Ery. mean corpuscular hemoglobin (pg/cell)<0.9*LLN | 1 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Bicarbonate (mEq/L)<0.9x LLN | 4 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Lymphocytes (10^3/mm3)<0.8x LLN | 3 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Erythrocytes (10^6/mm3)<0.8x LLN | 1 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Glucose (mg/dL)>1.5x ULN | 6 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Hemoglobin (g/dL)<0.8*LLN | 2 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | HDL cholesterol (mg/dL)<0.8x LLN | 3 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Urine hemoglobin ≥ 1 | 2 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Protein (g/dL)<0.8x LLN | 1 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Phosphate (mg/dL)<0.8x LLN | 1 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Urobilinogen≥1 | 2 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Calcium (mg/dL)<0.9x LLN | 1 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Ketones≥1 | 1 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Nitrite≥1 | 0 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Alanine aminotransferase (U/L)>3.0*ULN | 1 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Urea nitrogen (mg/dL)>1.3x ULN | 0 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Leukocyte esterase ≥ 1 | 2 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Hematocrit (%)<0.8x LLN | 2 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Triglycerides (mg/dL)>1.3x ULN | 1 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Urine erythrocytes (/HPF)≥20 | 2 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Creatinine (mg/dL)>1.3x ULN | 0 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Ery. mean corpuscular volume (um^3)<0.9*LLN | 1 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Urine leukocytes (Scalar)≥20 | 1 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Albumin (g/dL) <0.8x LLN | 0 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Urine leukocytes (Scalar)≥20 | 0 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Hemoglobin (g/dL)<0.8*LLN | 1 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Hematocrit (%)<0.8x LLN | 0 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Erythrocytes (10^6/mm3)<0.8x LLN | 0 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Ery. mean corpuscular volume (um^3)<0.9*LLN | 1 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Ery. mean corpuscular hemoglobin (pg/cell)<0.9*LLN | 1 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Lymphocytes (10^3/mm3)<0.8x LLN | 3 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Alanine aminotransferase (U/L)>3.0*ULN | 1 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Albumin (g/dL) <0.8x LLN | 1 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | URINE glucose≥1 | 0 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Urea nitrogen (mg/dL)>1.3x ULN | 1 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Creatinine (mg/dL)>1.3x ULN | 1 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Ketones≥1 | 0 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | HDL cholesterol (mg/dL)<0.8x LLN | 1 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Triglycerides (mg/dL)>1.3x ULN | 0 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Calcium (mg/dL)<0.9x LLN | 0 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Phosphate (mg/dL)<0.8x LLN | 0 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Bicarbonate (mEq/L)<0.9x LLN | 3 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Glucose (mg/dL)>1.5x ULN | 2 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Urine hemoglobin ≥ 1 | 1 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Urobilinogen≥1 | 1 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Nitrite≥1 | 0 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Leukocyte esterase ≥ 1 | 0 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Urine erythrocytes (/HPF)≥20 | 0 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD | Protein (g/dL)<0.8x LLN | 1 Participants |
Primary
Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 1: SAD
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 1: SAD | Treatment-related TEAEs | 0 Participants |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 1: SAD | Treatment-related SAEs | 0 Participants |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 1: SAD | All-causality severe AEs | 1 Participants |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 1: SAD | Treatment-related severe AEs | 0 Participants |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 1: SAD | All-causality TEAEs | 1 Participants |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 1: SAD | All-causality SAEs | 1 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 1: SAD | All-causality severe AEs | 1 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 1: SAD | All-causality TEAEs | 1 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 1: SAD | All-causality SAEs | 0 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 1: SAD | Treatment-related SAEs | 0 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 1: SAD | Treatment-related TEAEs | 0 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 1: SAD | Treatment-related severe AEs | 0 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 1: SAD | Treatment-related SAEs | 0 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 1: SAD | All-causality severe AEs | 1 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 1: SAD | Treatment-related severe AEs | 0 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 1: SAD | All-causality TEAEs | 2 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 1: SAD | All-causality SAEs | 1 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 1: SAD | Treatment-related TEAEs | 1 Participants |
| Part 1: 250 mg Placebo 24-hours Continuous Infusion | Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 1: SAD | Treatment-related SAEs | 0 Participants |
| Part 1: 250 mg Placebo 24-hours Continuous Infusion | Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 1: SAD | All-causality severe AEs | 1 Participants |
| Part 1: 250 mg Placebo 24-hours Continuous Infusion | Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 1: SAD | Treatment-related severe AEs | 0 Participants |
| Part 1: 250 mg Placebo 24-hours Continuous Infusion | Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 1: SAD | All-causality TEAEs | 2 Participants |
| Part 1: 250 mg Placebo 24-hours Continuous Infusion | Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 1: SAD | Treatment-related TEAEs | 1 Participants |
| Part 1: 250 mg Placebo 24-hours Continuous Infusion | Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 1: SAD | All-causality SAEs | 1 Participants |
Primary
Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 2: MAD
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 2: MAD | All-causality TEAEs | 2 Participants |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 2: MAD | Treatment-related TEAEs | 0 Participants |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 2: MAD | All-causality SAEs | 1 Participants |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 2: MAD | Treatment-related SAEs | 0 Participants |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 2: MAD | All-causality severe AEs | 0 Participants |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 2: MAD | Treatment-related severe AEs | 0 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 2: MAD | Treatment-related severe AEs | 0 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 2: MAD | All-causality TEAEs | 4 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 2: MAD | Treatment-related SAEs | 0 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 2: MAD | All-causality severe AEs | 2 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 2: MAD | Treatment-related TEAEs | 0 Participants |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 2: MAD | All-causality SAEs | 2 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 2: MAD | Treatment-related TEAEs | 1 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 2: MAD | All-causality SAEs | 1 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 2: MAD | Treatment-related severe AEs | 0 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 2: MAD | Treatment-related SAEs | 0 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 2: MAD | All-causality TEAEs | 3 Participants |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 2: MAD | All-causality severe AEs | 1 Participants |
Primary
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
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Day 1 - 6 hours | -12.5 Beats per minute | Standard Deviation 4.95 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 1 | -8.0 Beats per minute | Standard Deviation 11.31 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Day 1 - 30 minutes | -3.5 Beats per minute | Standard Deviation 3.54 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | — |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Day 1 - 12 hours | -7.0 Beats per minute | Standard Deviation 11.31 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Baseline | 87.5 Beats per minute | Standard Deviation 3.54 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Day 1 - 2 hours | 2.0 Beats per minute | Standard Deviation 8.49 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: End of Treatment | -7.0 Beats per minute | Standard Deviation 5.66 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Day 1 - 12 hours | 3.0 Beats per minute | Standard Deviation 5.66 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 1 | -2.0 Beats per minute | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: End of Treatment | -9.0 Beats per minute | Standard Deviation 7.07 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Baseline | 71.5 Beats per minute | Standard Deviation 4.95 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | 1.0 Beats per minute | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Day 1 - 6 hours | 2.5 Beats per minute | Standard Deviation 0.71 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Day 1 - 12 hours | -9.5 Beats per minute | Standard Deviation 3.54 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Baseline | 66.0 Beats per minute | Standard Deviation 15.56 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Day 1 - 30 minutes | -5.5 Beats per minute | Standard Deviation 0.71 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Day 1 - 2 hours | -4.0 Beats per minute | Standard Deviation 2.83 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Day 1 - 6 hours | -13.5 Beats per minute | Standard Deviation 9.19 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: End of Treatment | 2.5 Beats per minute | Standard Deviation 10.61 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 1 | -3.5 Beats per minute | Standard Deviation 0.71 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | 1.0 Beats per minute | — |
| Part 1: 250 mg Placebo 24-hours Continuous 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 | -8.0 Beats per minute | — |
| Part 1: 250 mg Placebo 24-hours Continuous 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 1 | 8.0 Beats per minute | Standard Deviation 5.66 |
| Part 1: 250 mg Placebo 24-hours Continuous 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: Day 1 - 6 hours | 7.5 Beats per minute | Standard Deviation 13.44 |
| Part 1: 250 mg Placebo 24-hours Continuous 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: Baseline | 71.0 Beats per minute | Standard Deviation 7.07 |
| Part 1: 250 mg Placebo 24-hours Continuous 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: End of Treatment | -4.0 Beats per minute | Standard Deviation 2.83 |
| Part 1: 250 mg Placebo 24-hours Continuous 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: Day 1 - 12 hours | 8.5 Beats per minute | Standard Deviation 10.61 |
Primary
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
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: Follow Up 4 | -6.0 Beats per minute | — |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: Follow Up 1 | 2.8 Beats per minute | Standard Deviation 17.73 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: Day 3 | -8.7 Beats per minute | Standard Deviation 15.49 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: End of Treatment | -8.7 Beats per minute | Standard Deviation 16.65 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: Day 2 | -4.7 Beats per minute | Standard Deviation 8.52 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: Follow Up 3 | 8.5 Beats per minute | Standard Deviation 12.07 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: Follow Up 2 | 7.0 Beats per minute | Standard Deviation 12.68 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: Day 5 | -6.7 Beats per minute | Standard Deviation 13.28 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: Day 2 | -6.0 Beats per minute | Standard Deviation 18.9 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: Follow Up 1 | -6.9 Beats per minute | Standard Deviation 8.63 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: Follow Up 2 | -26.0 Beats per minute | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: Follow Up 3 | -12.5 Beats per minute | Standard Deviation 16.26 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: Follow Up 4 | 8.0 Beats per minute | Standard Deviation 21.38 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | 80.1 Beats per minute | Standard Deviation 11.29 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: Day 3 | -12.0 Beats per minute | Standard Deviation 15.01 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: Day 5 | -9.0 Beats per minute | Standard Deviation 8.04 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: End of Treatment | -8.4 Beats per minute | Standard Deviation 13.46 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: End of Treatment | -15.0 Beats per minute | Standard Deviation 42.79 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Day 3 | -7.5 Beats per minute | Standard Deviation 18.91 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Follow Up 3 | 6.0 Beats per minute | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Early Termination | 9.0 Beats per minute | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Day 5 | -13.7 Beats per minute | Standard Deviation 27.61 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Follow Up 2 | 2.0 Beats per minute | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Follow Up 1 | 21.0 Beats per minute | Standard Deviation 10.44 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | 85.0 Beats per minute | Standard Deviation 41.16 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Day 2 | -0.7 Beats per minute | Standard Deviation 2.08 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Follow Up 4 | 21.0 Beats per minute | — |
Primary
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
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QRS interval: Change from Baseline: Follow Up 2 | -1.0 Millisecond | — |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QTcF: Change from Baseline: Day 1 - 12 hours | 17.5 Millisecond | Standard Deviation 12.02 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QT interval: Baseline | 348.5 Millisecond | Standard Deviation 30.41 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QRS interval: Change from Baseline: Day 1 - 6 hours | -2.5 Millisecond | Standard Deviation 2.12 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Follow Up 2 | 9.0 Millisecond | — |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QTcF: Change from Baseline: End of Treatment | 18.5 Millisecond | Standard Deviation 7.78 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QT interval: Change from Baseline: Follow Up 2 | 38.0 Millisecond | — |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QT interval: Change from Baseline: Day 1 - 6 hours | 24.5 Millisecond | Standard Deviation 10.61 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QRS interval: Change from Baseline: Follow Up 1 | 1.0 Millisecond | Standard Deviation 0 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QTcF: Change from Baseline: Follow Up 1 | 16.0 Millisecond | Standard Deviation 8.49 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QTcF: Baseline | 395.0 Millisecond | Standard Deviation 28.28 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QT interval: Change from Baseline: Day 1 - 30 minutes | 5.5 Millisecond | Standard Deviation 21.92 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QRS interval: Change from Baseline: Day 1 - 2 hours | -2.5 Millisecond | Standard Deviation 0.71 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QTcF: Change from Baseline: Follow Up 2 | 18.0 Millisecond | — |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: End of Treatment | -8.0 Millisecond | Standard Deviation 2.83 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QT interval: Change from Baseline: Follow Up 1 | 28.5 Millisecond | Standard Deviation 26.16 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QRS interval: Change from Baseline: End of Treatment | 1.5 Millisecond | Standard Deviation 6.36 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Baseline | 153.0 Millisecond | Standard Deviation 5.66 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QRS interval: Change from Baseline: Day 1 - 12 hours | -2.5 Millisecond | Standard Deviation 0.71 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QRS interval: Change from Baseline: Day 1 - 30 minutes | -2.0 Millisecond | Standard Deviation 5.66 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QT interval: Change from Baseline: Day 1 - 12 hours | 28.5 Millisecond | Standard Deviation 30.41 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QRS interval: Baseline | 92.5 Millisecond | Standard Deviation 2.12 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 - 2 hours | -6.0 Millisecond | Standard Deviation 14.14 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 - 12 hours | -4.0 Millisecond | Standard Deviation 11.31 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QTcF: Change from Baseline: Day 1 - 30 minutes | -1.0 Millisecond | Standard Deviation 19.8 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Follow Up 1 | -3.5 Millisecond | Standard Deviation 12.02 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QTcF: Change from Baseline: Day 1 - 2 hours | -2.0 Millisecond | Standard Deviation 2.83 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QT interval: Change from Baseline: Day 1 - 2 hours | -3.5 Millisecond | Standard Deviation 12.02 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QTcF: Change from Baseline: Day 1 - 6 hours | 7.0 Millisecond | Standard Deviation 16.97 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 - 6 hours | -3.5 Millisecond | Standard Deviation 4.95 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QT interval: Change from Baseline: End of Treatment | 28.0 Millisecond | Standard Deviation 16.97 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | QT interval: Change from Baseline: End of Treatment | 28.5 Millisecond | Standard Deviation 36.06 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 - 6 hours | -1.5 Millisecond | Standard Deviation 7.78 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 - 12 hours | -11.0 Millisecond | Standard Deviation 19.8 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | QT interval: Change from Baseline: Follow Up 2 | -13.0 Millisecond | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: End of Treatment | 1.5 Millisecond | Standard Deviation 10.61 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | QRS interval: Change from Baseline: Day 1 - 6 hours | -3.0 Millisecond | Standard Deviation 12.73 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Follow Up 1 | 5.0 Millisecond | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Follow Up 2 | -1.0 Millisecond | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | QRS interval: Baseline | 99.0 Millisecond | Standard Deviation 4.24 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | QTcF: Baseline | 423.0 Millisecond | Standard Deviation 41.01 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | QT interval: Change from Baseline: Day 1 - 12 hours | -1.0 Millisecond | Standard Deviation 1.41 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | QRS interval: Change from Baseline: Follow Up 2 | -2.0 Millisecond | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | QT interval: Change from Baseline: Day 1 - 6 hours | -16.5 Millisecond | Standard Deviation 24.75 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | QTcF: Change from Baseline: Day 1 - 6 hours | -10.5 Millisecond | Standard Deviation 23.33 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | QTcF: Change from Baseline: Day 1 - 12 hours | 5.0 Millisecond | Standard Deviation 7.07 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | QT interval: Baseline | 401.0 Millisecond | Standard Deviation 48.08 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | QRS interval: Change from Baseline: Follow Up 1 | -1.0 Millisecond | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | QTcF: Change from Baseline: End of Treatment | 9.0 Millisecond | Standard Deviation 14.14 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | QTcF: Change from Baseline: Follow Up 1 | 1.0 Millisecond | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | QRS interval: Change from Baseline: End of Treatment | 0.0 Millisecond | Standard Deviation 1.41 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | QTcF: Change from Baseline: Follow Up 2 | -12.0 Millisecond | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Baseline | 165.0 Millisecond | Standard Deviation 29.7 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | QT interval: Change from Baseline: Follow Up 1 | 2.0 Millisecond | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | QRS interval: Change from Baseline: Day 1 - 12 hours | 0.0 Millisecond | Standard Deviation 5.66 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Follow Up 1 | -2.0 Millisecond | Standard Deviation 12.73 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QT interval: Change from Baseline: Day 1 - 6 hours | 19.5 Millisecond | Standard Deviation 38.89 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QT interval: Change from Baseline: Day 1 - 12 hours | 30.0 Millisecond | Standard Deviation 19.8 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QT interval: Change from Baseline: End of Treatment | -6.5 Millisecond | Standard Deviation 37.48 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QT interval: Change from Baseline: Follow Up 1 | -12.0 Millisecond | Standard Deviation 15.56 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QT interval: Change from Baseline: Follow Up 2 | -23.0 Millisecond | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QTcF: Baseline | 408.0 Millisecond | Standard Deviation 1.41 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QTcF: Change from Baseline: Day 1 - 30 minutes | -10.0 Millisecond | Standard Deviation 14.14 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QTcF: Change from Baseline: Day 1 - 2 hours | -8.5 Millisecond | Standard Deviation 9.19 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QTcF: Change from Baseline: Day 1 - 6 hours | -9.5 Millisecond | Standard Deviation 21.92 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QTcF: Change from Baseline: Day 1 - 12 hours | 9.5 Millisecond | Standard Deviation 17.68 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QTcF: Change from Baseline: End of Treatment | 0.5 Millisecond | Standard Deviation 16.26 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QTcF: Change from Baseline: Follow Up 1 | -19.0 Millisecond | Standard Deviation 15.56 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QTcF: Change from Baseline: Follow Up 2 | -21.0 Millisecond | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Baseline | 171.0 Millisecond | Standard Deviation 16.97 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | -1.5 Millisecond | Standard Deviation 0.71 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 - 2 hours | -2.5 Millisecond | Standard Deviation 2.12 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 - 6 hours | -2.5 Millisecond | Standard Deviation 4.95 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 - 12 hours | 0.5 Millisecond | Standard Deviation 3.54 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: End of Treatment | -7.5 Millisecond | Standard Deviation 6.36 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QT interval: Change from Baseline: Day 1 - 2 hours | -1.0 Millisecond | Standard Deviation 14.14 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Follow Up 2 | -7.0 Millisecond | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QRS interval: Baseline | 95.0 Millisecond | Standard Deviation 8.49 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QRS interval: Change from Baseline: Day 1 - 30 minutes | 1.0 Millisecond | Standard Deviation 2.83 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QRS interval: Change from Baseline: Day 1 - 2 hours | 1.0 Millisecond | Standard Deviation 1.41 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QRS interval: Change from Baseline: Day 1 - 6 hours | -2.0 Millisecond | Standard Deviation 2.83 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QRS interval: Change from Baseline: Day 1 - 12 hours | -3.0 Millisecond | Standard Deviation 0 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QRS interval: Change from Baseline: End of Treatment | 0.0 Millisecond | Standard Deviation 4.24 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QRS interval: Change from Baseline: Follow Up 1 | -5.0 Millisecond | Standard Deviation 1.41 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QRS interval: Change from Baseline: Follow Up 2 | 2.0 Millisecond | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QT interval: Baseline | 397.5 Millisecond | Standard Deviation 30.41 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QT interval: Change from Baseline: Day 1 - 30 minutes | 1.0 Millisecond | Standard Deviation 12.73 |
| Part 1: 250 mg Placebo 24-hours Continuous 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: Baseline | 183.5 Millisecond | Standard Deviation 10.61 |
| Part 1: 250 mg Placebo 24-hours Continuous 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 | QT interval: Baseline | 389.0 Millisecond | Standard Deviation 22.63 |
| Part 1: 250 mg Placebo 24-hours Continuous 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 | QRS interval: Change from Baseline: Day 1 - 12 hours | -0.5 Millisecond | Standard Deviation 3.54 |
| Part 1: 250 mg Placebo 24-hours Continuous 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 | QTcF: Change from Baseline: Follow Up 2 | 24.0 Millisecond | — |
| Part 1: 250 mg Placebo 24-hours Continuous 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 | QTcF: Change from Baseline: Follow Up 1 | 6.0 Millisecond | Standard Deviation 9.9 |
| Part 1: 250 mg Placebo 24-hours Continuous 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 | QT interval: Change from Baseline: End of Treatment | 15.0 Millisecond | Standard Deviation 11.31 |
| Part 1: 250 mg Placebo 24-hours Continuous 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 | QRS interval: Change from Baseline: End of Treatment | 0.5 Millisecond | Standard Deviation 0.71 |
| Part 1: 250 mg Placebo 24-hours Continuous 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 | QTcF: Change from Baseline: End of Treatment | 6.5 Millisecond | Standard Deviation 6.36 |
| Part 1: 250 mg Placebo 24-hours Continuous 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 | QTcF: Change from Baseline: Day 1 - 12 hours | -6.0 Millisecond | Standard Deviation 9.9 |
| Part 1: 250 mg Placebo 24-hours Continuous 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 | QT interval: Change from Baseline: Day 1 - 6 hours | -13.5 Millisecond | Standard Deviation 28.99 |
| Part 1: 250 mg Placebo 24-hours Continuous 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 | QRS interval: Change from Baseline: Follow Up 1 | 0.0 Millisecond | Standard Deviation 2.83 |
| Part 1: 250 mg Placebo 24-hours Continuous 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 | QTcF: Change from Baseline: Day 1 - 6 hours | -1.0 Millisecond | Standard Deviation 7.07 |
| Part 1: 250 mg Placebo 24-hours Continuous 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 | QTcF: Baseline | 411.5 Millisecond | Standard Deviation 10.61 |
| Part 1: 250 mg Placebo 24-hours Continuous 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 | QT interval: Change from Baseline: Day 1 - 12 hours | -20.0 Millisecond | Standard Deviation 28.28 |
| Part 1: 250 mg Placebo 24-hours Continuous 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 | QRS interval: Change from Baseline: Follow Up 2 | 1.0 Millisecond | — |
| Part 1: 250 mg Placebo 24-hours Continuous 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 | QRS interval: Baseline | 103.0 Millisecond | Standard Deviation 4.24 |
| Part 1: 250 mg Placebo 24-hours Continuous 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 | QT interval: Change from Baseline: Follow Up 2 | 38.0 Millisecond | — |
| Part 1: 250 mg Placebo 24-hours Continuous 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: Follow Up 2 | -11.0 Millisecond | — |
| Part 1: 250 mg Placebo 24-hours Continuous 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 | QT interval: Change from Baseline: Follow Up 1 | -8.5 Millisecond | Standard Deviation 2.12 |
| Part 1: 250 mg Placebo 24-hours Continuous 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: Follow Up 1 | -16.5 Millisecond | Standard Deviation 6.36 |
| Part 1: 250 mg Placebo 24-hours Continuous 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: End of Treatment | -7.0 Millisecond | Standard Deviation 5.66 |
| Part 1: 250 mg Placebo 24-hours Continuous 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 - 12 hours | -19.5 Millisecond | Standard Deviation 4.95 |
| Part 1: 250 mg Placebo 24-hours Continuous 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 | QRS interval: Change from Baseline: Day 1 - 6 hours | 0.0 Millisecond | Standard Deviation 1.41 |
| Part 1: 250 mg Placebo 24-hours Continuous 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 - 6 hours | -14.5 Millisecond | Standard Deviation 4.95 |
Primary
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
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QTcF: Change from Baseline: Day 2 | 17.5 Millisecond | Standard Deviation 20.96 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QTcF: Change from Baseline: Follow Up 3 | -7.3 Millisecond | Standard Deviation 9.54 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: Follow Up 4 | 15.0 Millisecond | — |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QT interval: Change from Baseline: Day 3 | 27.5 Millisecond | Standard Deviation 59.06 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QRS interval: Baseline | 93.7 Millisecond | Standard Deviation 4.68 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QRS interval: Change from Baseline: Follow Up 2 | 2.3 Millisecond | Standard Deviation 4.5 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QT interval: Change from Baseline: Day 2 | 25.3 Millisecond | Standard Deviation 35.59 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QRS interval: Change from Baseline: Day 2 | 6.7 Millisecond | Standard Deviation 7.94 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QTcF: Baseline | 404.7 Millisecond | Standard Deviation 18.13 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QT interval: Baseline | 385.5 Millisecond | Standard Deviation 24.74 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QRS interval: Change from Baseline: Day 3 | -0.7 Millisecond | Standard Deviation 3.08 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: Day 2 | 3.8 Millisecond | Standard Deviation 14.76 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QRS interval: Change from Baseline: Follow Up 4 | -12.0 Millisecond | — |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QRS interval: Change from Baseline: Day 5 | 0.7 Millisecond | Standard Deviation 2.88 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QRS interval: Change from Baseline: Follow Up 1 | 1.0 Millisecond | Standard Deviation 4.18 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QRS interval: Change from Baseline: Follow Up 3 | -0.3 Millisecond | Standard Deviation 4.86 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QRS interval: Change from Baseline: End of Treatment | 0.3 Millisecond | Standard Deviation 3.78 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QT interval: Change from Baseline: Follow Up 4 | 5.0 Millisecond | — |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: Day 3 | 1.2 Millisecond | Standard Deviation 17.88 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QTcF: Change from Baseline: Follow Up 1 | -7.2 Millisecond | Standard Deviation 9.09 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QT interval: Change from Baseline: Follow Up 3 | -22.0 Millisecond | Standard Deviation 22.17 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: Day 5 | 5.7 Millisecond | Standard Deviation 19.81 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QTcF: Change from Baseline: End of Treatment | 3.7 Millisecond | Standard Deviation 16.5 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QT interval: Change from Baseline: Follow Up 2 | -19.3 Millisecond | Standard Deviation 27 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: End of Treatment | 9.3 Millisecond | Standard Deviation 15.46 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QTcF: Change from Baseline: Day 3 | 8.3 Millisecond | Standard Deviation 27.66 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QT interval: Change from Baseline: Follow Up 1 | -10.2 Millisecond | Standard Deviation 39.09 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QT interval: Change from Baseline: End of Treatment | 21.8 Millisecond | Standard Deviation 46.1 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: Follow Up 1 | 7.2 Millisecond | Standard Deviation 18.63 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QTcF: Change from Baseline: Follow Up 2 | -5.8 Millisecond | Standard Deviation 9 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QT interval: Change from Baseline: Day 5 | 12.5 Millisecond | Standard Deviation 31.04 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: Follow Up 2 | 6.8 Millisecond | Standard Deviation 28.85 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QTcF: Change from Baseline: Day 5 | -0.2 Millisecond | Standard Deviation 11.82 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | QTcF: Change from Baseline: Follow Up 4 | -6.0 Millisecond | — |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: Follow Up 3 | 12.0 Millisecond | Standard Deviation 24.45 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | QRS interval: Change from Baseline: Follow Up 2 | 16.0 Millisecond | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | QTcF: Change from Baseline: Day 5 | 16.4 Millisecond | Standard Deviation 20.74 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | QTcF: Change from Baseline: End of Treatment | 10.7 Millisecond | Standard Deviation 17.93 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | QTcF: Change from Baseline: Follow Up 1 | 9.1 Millisecond | Standard Deviation 18.43 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | QTcF: Change from Baseline: Follow Up 2 | 18.0 Millisecond | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | 139.7 Millisecond | Standard Deviation 19.14 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: Day 2 | -5.0 Millisecond | Standard Deviation 15.17 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: Day 3 | -3.2 Millisecond | Standard Deviation 9.91 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: Day 5 | -1.6 Millisecond | Standard Deviation 13.5 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: End of Treatment | -0.6 Millisecond | Standard Deviation 15.82 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: Follow Up 1 | 1.4 Millisecond | Standard Deviation 17.86 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: Follow Up 2 | -30.0 Millisecond | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: Follow Up 3 | -21.0 Millisecond | Standard Deviation 31.11 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: Follow Up 4 | -4.0 Millisecond | Standard Deviation 19.31 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | QRS interval: Baseline | 93.6 Millisecond | Standard Deviation 10.63 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | QRS interval: Change from Baseline: Day 2 | 1.7 Millisecond | Standard Deviation 5.09 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | QRS interval: Change from Baseline: Day 3 | 3.5 Millisecond | Standard Deviation 5.32 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | QRS interval: Change from Baseline: Day 5 | 3.0 Millisecond | Standard Deviation 3.92 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | QRS interval: Change from Baseline: Follow Up 3 | 6.0 Millisecond | Standard Deviation 5.66 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | QRS interval: Change from Baseline: Follow Up 4 | 7.0 Millisecond | Standard Deviation 3.61 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | QT interval: Baseline | 366.1 Millisecond | Standard Deviation 22.17 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | QT interval: Change from Baseline: Day 2 | 16.2 Millisecond | Standard Deviation 48.16 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | QT interval: Change from Baseline: Day 3 | 27.3 Millisecond | Standard Deviation 43.01 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | QTcF: Change from Baseline: Follow Up 3 | 4.5 Millisecond | Standard Deviation 13.44 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | QTcF: Change from Baseline: Follow Up 4 | 2.3 Millisecond | Standard Deviation 19.43 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | QT interval: Change from Baseline: Day 5 | 29.0 Millisecond | Standard Deviation 21.57 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | QT interval: Change from Baseline: End of Treatment | 23.3 Millisecond | Standard Deviation 31.07 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | QT interval: Change from Baseline: Follow Up 1 | 20.9 Millisecond | Standard Deviation 16.82 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | QT interval: Change from Baseline: Follow Up 2 | 63.0 Millisecond | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | QT interval: Change from Baseline: Follow Up 3 | 24.5 Millisecond | Standard Deviation 13.44 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | QT interval: Change from Baseline: Follow Up 4 | -4.0 Millisecond | Standard Deviation 39.36 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | QTcF: Baseline | 401.3 Millisecond | Standard Deviation 10.44 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | QTcF: Change from Baseline: Day 2 | 6.8 Millisecond | Standard Deviation 19.75 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | QTcF: Change from Baseline: Day 3 | 8.0 Millisecond | Standard Deviation 21.8 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | QRS interval: Change from Baseline: End of Treatment | 5.6 Millisecond | Standard Deviation 5.56 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | QRS interval: Change from Baseline: Follow Up 1 | 4.0 Millisecond | Standard Deviation 6.43 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Follow Up 2 | -6.0 Millisecond | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QTcF: Change from Baseline: Day 2 | 9.0 Millisecond | Standard Deviation 7.94 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QTcF: Change from Baseline: Follow Up 4 | 7.0 Millisecond | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QT interval: Change from Baseline: Day 3 | 10.0 Millisecond | Standard Deviation 37.34 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Follow Up 1 | -8.0 Millisecond | Standard Deviation 18.36 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QTcF: Change from Baseline: Follow Up 1 | -15.7 Millisecond | Standard Deviation 23.01 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QT interval: Change from Baseline: Day 5 | 28.0 Millisecond | Standard Deviation 61.54 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Early Termination | -1.0 Millisecond | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QRS interval: Change from Baseline: Follow Up 1 | 2.3 Millisecond | Standard Deviation 6.35 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QT interval: Change from Baseline: End of Treatment | 8.0 Millisecond | Standard Deviation 60.61 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QT interval: Change from Baseline: Early Termination | -17.0 Millisecond | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: End of Treatment | -0.3 Millisecond | Standard Deviation 7.64 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QTcF: Change from Baseline: Day 3 | 7.5 Millisecond | Standard Deviation 24.19 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QT interval: Change from Baseline: Follow Up 1 | -49.7 Millisecond | Standard Deviation 32.59 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Day 5 | -3.0 Millisecond | Standard Deviation 14.14 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QTcF: Change from Baseline: End of Treatment | -1.3 Millisecond | Standard Deviation 15.5 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QT interval: Change from Baseline: Follow Up 2 | 0.0 Millisecond | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Day 3 | 6.0 Millisecond | Standard Deviation 11.36 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QRS interval: Change from Baseline: End of Treatment | 2.3 Millisecond | Standard Deviation 3.51 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QT interval: Change from Baseline: Follow Up 3 | -21.0 Millisecond | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Day 2 | 1.3 Millisecond | Standard Deviation 4.51 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QRS interval: Change from Baseline: Early Termination | -3.0 Millisecond | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QRS interval: Change from Baseline: Follow Up 2 | 8.0 Millisecond | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QRS interval: Change from Baseline: Day 5 | 7.0 Millisecond | Standard Deviation 5.29 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QT interval: Change from Baseline: Follow Up 4 | -36.0 Millisecond | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QRS interval: Change from Baseline: Follow Up 3 | 15.0 Millisecond | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QRS interval: Change from Baseline: Day 3 | 3.3 Millisecond | Standard Deviation 3.3 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | 156.0 Millisecond | Standard Deviation 28.31 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QRS interval: Change from Baseline: Follow Up 4 | 5.0 Millisecond | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QRS interval: Change from Baseline: Day 2 | 4.7 Millisecond | Standard Deviation 7.09 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QTcF: Change from Baseline: Early Termination | -1.0 Millisecond | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QT interval: Baseline | 373.8 Millisecond | Standard Deviation 59.57 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QRS interval: Baseline | 90.5 Millisecond | Standard Deviation 4.43 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QTcF: Baseline | 405.3 Millisecond | Standard Deviation 18.84 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QT interval: Change from Baseline: Day 2 | 8.3 Millisecond | Standard Deviation 9.07 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Follow Up 4 | -23.0 Millisecond | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QTcF: Change from Baseline: Follow Up 2 | 9.0 Millisecond | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Follow Up 3 | -18.0 Millisecond | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QTcF: Change from Baseline: Day 5 | 19.7 Millisecond | Standard Deviation 39.37 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | QTcF: Change from Baseline: Follow Up 3 | -7.0 Millisecond | — |
Primary
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
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 Never Received | 93.0 percentage of SpO2 | — |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | Change from Baseline: Follow Up 1: Oxygen Never Received | 1.0 percentage of SpO2 | — |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | Change from Baseline: Follow Up 2: Oxygen Received Throughout | 0.0 percentage of SpO2 | — |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | — |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | Change from Baseline: End of Treatment: Oxygen Received Throughout: | 3.0 percentage of SpO2 | — |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | Change from Baseline: End of Treatment: Oxygen Never Received | 1.0 percentage of SpO2 | — |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | Change from Baseline: Follow Up 1: Oxygen Received Throughout | 3.0 percentage of SpO2 | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Change from Baseline: End of Treatment: Oxygen Received Throughout: | 5.0 percentage of SpO2 | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | 90.0 percentage of SpO2 | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Change from Baseline: Follow Up 1: Oxygen Received at Some Point During Study | 5.0 percentage of SpO2 | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Change from Baseline: Follow Up 2: Oxygen Received Throughout | 5.0 percentage of SpO2 | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 at Some Point During Study | 91.0 percentage of SpO2 | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Change from Baseline: Follow Up 1: Oxygen Received Throughout | 1.0 percentage of SpO2 | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Change from Baseline: End of Treatment: Oxygen Received at Some Point During Study | 5.0 percentage of SpO2 | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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 at Some Point During Study | 95.0 percentage of SpO2 | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | Change from Baseline: End of Treatment: Oxygen Received Throughout: | 0.0 percentage of SpO2 | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | Change from Baseline: End of Treatment: Oxygen Received at Some Point During Study | -4.0 percentage of SpO2 | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | Change from Baseline: Follow Up 1: Oxygen Received Throughout | 0.0 percentage of SpO2 | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | Change from Baseline: Follow Up 1: Oxygen Received at Some Point During Study | 1.0 percentage of SpO2 | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | Change from Baseline: Follow Up 2: Oxygen Received Throughout | -5.0 percentage of SpO2 | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | 98.0 percentage of SpO2 | — |
| Part 1: 250 mg Placebo 24-hours Continuous 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 | Change from Baseline: Follow Up 1: Oxygen Received Throughout | 0.0 percentage of SpO2 | — |
| Part 1: 250 mg Placebo 24-hours Continuous 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 | Change from Baseline: End of Treatment: Oxygen Received Throughout: | -0.5 percentage of SpO2 | Standard Deviation 0.71 |
| Part 1: 250 mg Placebo 24-hours Continuous 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 | 94.5 percentage of SpO2 | Standard Deviation 0.71 |
| Part 1: 250 mg Placebo 24-hours Continuous 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 | Change from Baseline: Follow Up 2: Oxygen Received Throughout | -1.5 percentage of SpO2 | Standard Deviation 0.71 |
Primary
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
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | Change from Baseline: Follow Up 1: Oxygen Received at Some Point During Study | -2.5 percentage of SpO2 | Standard Deviation 0.71 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | Change from Baseline: Day 4: Oxygen Received Throughout | 2.0 percentage of SpO2 | Standard Deviation 2.45 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | Change from Baseline: Follow Up 3: Oxygen Received Throughout | 3.7 percentage of SpO2 | Standard Deviation 4.04 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | Change from Baseline: Follow Up 1: Oxygen Received Throughout | 2.0 percentage of SpO2 | Standard Deviation 2.45 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | Change from Baseline: Day 4: Oxygen Received at Some Point During Study | -1.0 percentage of SpO2 | Standard Deviation 0 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | Change from Baseline: Day 2: Oxygen Received at Some Point During Study | 1.0 percentage of SpO2 | Standard Deviation 0 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | Change from Baseline: End of Treatment: Oxygen Received at Some Point During Study | 0.0 percentage of SpO2 | Standard Deviation 2.83 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | Change from Baseline: Follow Up 4: Oxygen Received Throughout | 3.0 percentage of SpO2 | Standard Deviation 1.41 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | Change from Baseline: Day 5: Oxygen Received Throughout | 3.0 percentage of SpO2 | Standard Deviation 4.08 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | Change from Baseline: Follow Up 2: Oxygen Received at Some Point During Study | -2.0 percentage of SpO2 | — |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | Change from Baseline: End of Treatment: Oxygen Received Throughout | 0.8 percentage of SpO2 | Standard Deviation 3.86 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | Change from Baseline: Day 5: Oxygen Received at Some Point During Study | -1.5 percentage of SpO2 | Standard Deviation 0.71 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | Change from Baseline: Follow Up 3: Oxygen Received at Some Point During Study | 0.0 percentage of SpO2 | — |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | Change from Baseline: Day 3: Oxygen Received Throughout | 1.3 percentage of SpO2 | Standard Deviation 3.77 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 at Some Point During Study | 97.0 percentage of SpO2 | Standard Deviation 0 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | Change from Baseline: Follow Up 2: Oxygen Received Throughout | 3.3 percentage of SpO2 | Standard Deviation 4.04 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | Change from Baseline: Day 3: Oxygen Received at Some Point During Study | -2.0 percentage of SpO2 | Standard Deviation 2.83 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | Change from Baseline: Day 2: Oxygen Received Throughout | 2.0 percentage of SpO2 | Standard Deviation 3.74 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Change from Baseline: Day 2: Oxygen Received Throughout | -3.3 percentage of SpO2 | Standard Deviation 2.08 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | 96.3 percentage of SpO2 | Standard Deviation 0.58 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 at Some Point During Study | 96.0 percentage of SpO2 | Standard Deviation 2.65 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 Never Received | 98.0 percentage of SpO2 | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Change from Baseline: Day 2: Oxygen Received at Some Point During Study | -1.0 percentage of SpO2 | Standard Deviation 1 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Change from Baseline: Day 2: Oxygen Never Received | 2.0 percentage of SpO2 | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Change from Baseline: Day 3: Oxygen Received Throughout | -2.3 percentage of SpO2 | Standard Deviation 2.08 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Change from Baseline: Day 3: Oxygen Received at Some Point During Study | 0.0 percentage of SpO2 | Standard Deviation 1 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Change from Baseline: Day 3: Oxygen Never Received | -3.0 percentage of SpO2 | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Change from Baseline: Day 4: Oxygen Received Throughout | -0.7 percentage of SpO2 | Standard Deviation 2.52 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Change from Baseline: Day 4: Oxygen Received at Some Point During Study | -0.7 percentage of SpO2 | Standard Deviation 0.58 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Change from Baseline: Day 4: Oxygen Never Received | -3.0 percentage of SpO2 | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Change from Baseline: Day 5: Oxygen Received Throughout | -1.3 percentage of SpO2 | Standard Deviation 3.79 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Change from Baseline: Day 5: Oxygen Received at Some Point During Study | -1.3 percentage of SpO2 | Standard Deviation 2.08 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Change from Baseline: Day 5: Oxygen Never Received | -2.0 percentage of SpO2 | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Change from Baseline: End of Treatment: Oxygen Received Throughout | -1.0 percentage of SpO2 | Standard Deviation 1.73 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Change from Baseline: End of Treatment: Oxygen Received at Some Point During Study | 0.3 percentage of SpO2 | Standard Deviation 2.08 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Change from Baseline: End of Treatment: Oxygen Never Received | 0.0 percentage of SpO2 | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Change from Baseline: Follow Up 1: Oxygen Received Throughout | -1.0 percentage of SpO2 | Standard Deviation 0 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Change from Baseline: Follow Up 1: Oxygen Received at Some Point During Study | 0.0 percentage of SpO2 | Standard Deviation 1.73 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Change from Baseline: Follow Up 1: Oxygen Never Received | -1.0 percentage of SpO2 | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Change from Baseline: Follow Up 2: Oxygen Received Throughout | -2.0 percentage of SpO2 | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Change from Baseline: Follow Up 3: Oxygen Received Throughout | -2.0 percentage of SpO2 | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Change from Baseline: Follow Up 3: Oxygen Received at Some Point During Study | 2.0 percentage of SpO2 | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Change from Baseline: Follow Up 4: Oxygen Received Throughout | -0.5 percentage of SpO2 | Standard Deviation 3.54 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Change from Baseline: Follow Up 4: Oxygen Received at Some Point During Study | 1.0 percentage of SpO2 | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | Change from Baseline: Follow Up 1: Oxygen Received Throughout | 36.0 percentage of SpO2 | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | Change from Baseline: Day 3: Oxygen Received at Some Point During Study | -1.0 percentage of SpO2 | Standard Deviation 1 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 at Some Point During Study | 97.3 percentage of SpO2 | Standard Deviation 0.58 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | Change from Baseline: Follow Up 1: Oxygen Received at Some Point During Study | -3.0 percentage of SpO2 | Standard Deviation 2.83 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | Change from Baseline: Follow Up 4: Oxygen Received at Some Point During Study | -3.0 percentage of SpO2 | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | Change from Baseline: Day 3: Oxygen Received Throughout | 31.0 percentage of SpO2 | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | Change from Baseline: Follow Up 3: Oxygen Received at Some Point During Study | 0.5 percentage of SpO2 | Standard Deviation 0.71 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | Change from Baseline: Follow Up 2: Oxygen Received Throughout | 31.0 percentage of SpO2 | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | Change from Baseline: Day 5: Oxygen Received at Some Point During Study | -5.5 percentage of SpO2 | Standard Deviation 3.54 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | Change from Baseline: Day 2: Oxygen Received at Some Point During Study | -2.7 percentage of SpO2 | Standard Deviation 2.08 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | Change from Baseline: Day 5: Oxygen Received Throughout | 25.0 percentage of SpO2 | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | Change from Baseline: Follow Up 2: Oxygen Received at Some Point During Study | 1.0 percentage of SpO2 | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | Change from Baseline: End of Treatment: Oxygen Received Throughout | 34.0 percentage of SpO2 | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | Change from Baseline: Day 4: Oxygen Received at Some Point During Study | -3.5 percentage of SpO2 | Standard Deviation 2.12 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | Change from Baseline: Day 2: Oxygen Received Throughout | 34.0 percentage of SpO2 | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | Change from Baseline: End of Treatment: Oxygen Received at Some Point During Study | -5.5 percentage of SpO2 | Standard Deviation 0.71 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | 60.0 percentage of SpO2 | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | Change from Baseline: Early Termination: Oxygen Received at Some Point During Study | -1.0 percentage of SpO2 | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | Change from Baseline: Day 4: Oxygen Received Throughout | 29.0 percentage of SpO2 | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | Change from Baseline: Follow Up 3: Oxygen Received Throughout | 31.0 percentage of SpO2 | — |
Primary
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
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: Day 1 - 30 minutes | 1.0 bpm | — |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: End of Treatment | -5.5 bpm | Standard Deviation 0.71 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: Day 1 - 12 hours | -12.0 bpm | — |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: Day 1 - 6 hours | -6.0 bpm | — |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: Follow Up 2 | 4.0 bpm | — |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: Follow Up 1 | -2.5 bpm | Standard Deviation 7.78 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: Day 1 - 2 hours | -2.0 bpm | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: Day 1 - 12 hours | 0.0 bpm | Standard Deviation 0 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | 74.5 bpm | Standard Deviation 4.95 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: Day 1 - 30 minutes | 10.0 bpm | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: Day 1 - 2 hours | 2.5 bpm | Standard Deviation 3.54 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: Day 1 - 6 hours | -8.0 bpm | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: End of Treatment | -4.5 bpm | Standard Deviation 17.68 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: Follow Up 1 | -7.0 bpm | Standard Deviation 1.41 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: Follow Up 2 | 3.0 bpm | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Day 1 - 12 hours | -11.0 bpm | Standard Deviation 1.41 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Day 1 - 2 hours | -5.0 bpm | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: End of Treatment | 2.5 bpm | Standard Deviation 10.61 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | 66.0 bpm | Standard Deviation 16.97 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Follow Up 1 | -1.0 bpm | Standard Deviation 1.41 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Day 1 - 30 minutes | -1.0 bpm | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Follow Up 2 | 5.0 bpm | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Day 1 - 6 hours | -7.0 bpm | — |
| Part 1: 250 mg Placebo 24-hours Continuous 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: Change from Baseline: Follow Up 1 | 15.0 bpm | — |
| Part 1: 250 mg Placebo 24-hours Continuous 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: Change from Baseline: Follow Up 2 | 5.0 bpm | Standard Deviation 9.9 |
| Part 1: 250 mg Placebo 24-hours Continuous 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: Change from Baseline: Day 1 - 12 hours | 6.0 bpm | Standard Deviation 7.07 |
| Part 1: 250 mg Placebo 24-hours Continuous 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: Change from Baseline: End of Treatment | -17.0 bpm | — |
| Part 1: 250 mg Placebo 24-hours Continuous 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: Change from Baseline: Day 1 - 30 minutes | 6.5 bpm | Standard Deviation 0.71 |
| Part 1: 250 mg Placebo 24-hours Continuous 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 | 75.5 bpm | Standard Deviation 6.36 |
| Part 1: 250 mg Placebo 24-hours Continuous 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: Change from Baseline: Day 1 - 2 hours | 16.0 bpm | Standard Deviation 24.04 |
Primary
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
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: Follow Up 2 | 13.0 bpm | Standard Deviation 9.83 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: Day 5 | -2.3 bpm | Standard Deviation 11.11 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: Follow Up 3 | 8.8 bpm | Standard Deviation 10.24 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: Follow Up 1 | -1.3 bpm | Standard Deviation 9.93 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: End of Treatment | -7.8 bpm | Standard Deviation 20.65 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: Day 3 | 3.5 bpm | Standard Deviation 11.52 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: Day 2 | -4.0 bpm | Standard Deviation 16.82 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: Day 4 | -6.0 bpm | Standard Deviation 17.47 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: Follow Up 4 | 12.0 bpm | Standard Deviation 12.73 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: End of Treatment | -9.1 bpm | Standard Deviation 16.34 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | 80.9 bpm | Standard Deviation 13.15 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: Day 2 | -5.4 bpm | Standard Deviation 10.64 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: Day 3 | -6.6 bpm | Standard Deviation 20.9 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: Day 4 | -10.6 bpm | Standard Deviation 10.39 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: Day 5 | -8.4 bpm | Standard Deviation 12.61 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: Follow Up 1 | -9.7 bpm | Standard Deviation 12.58 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: Follow Up 2 | -38.0 bpm | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: Follow Up 3 | 6.0 bpm | Standard Deviation 29.7 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: Follow Up 4 | 8.3 bpm | Standard Deviation 24.95 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Follow Up 1 | -11.3 bpm | Standard Deviation 32.46 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Day 4 | -18.3 bpm | Standard Deviation 24.79 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Day 3 | -3.0 bpm | Standard Deviation 8.6 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Follow Up 2 | -25.5 bpm | Standard Deviation 24.75 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Day 2 | -1.5 bpm | Standard Deviation 4.12 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Follow Up 4 | 12.0 bpm | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Follow Up 3 | -7.7 bpm | Standard Deviation 28.36 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: End of Treatment | -19.7 bpm | Standard Deviation 45.39 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Early Termination | -3.0 bpm | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Day 5 | -12.0 bpm | Standard Deviation 22.07 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | 90.3 bpm | Standard Deviation 30.38 |
Primary
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
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: End of Treatment | -2.5 breaths per minute | Standard Deviation 0.71 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: Follow Up 2 | -8.0 breaths per minute | — |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: Day 1 - 30 minutes | 0.0 breaths per minute | — |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: Follow Up 1 | -4.0 breaths per minute | Standard Deviation 2.83 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: Day 1 - 6 hours | -2.0 breaths per minute | — |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: Day 1 - 2 hours | 0.0 breaths per minute | — |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: Day 1 - 12 hours | -1.0 breaths per minute | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | 20.5 breaths per minute | Standard Deviation 3.54 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: Follow Up 2 | 4.0 breaths per minute | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: End of Treatment | -0.5 breaths per minute | Standard Deviation 2.12 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: Day 1 - 12 hours | -5.5 breaths per minute | Standard Deviation 10.61 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: Day 1 - 2 hours | -1.0 breaths per minute | Standard Deviation 4.24 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: Follow Up 1 | 0.5 breaths per minute | Standard Deviation 7.78 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: Day 1 - 6 hours | -0.5 breaths per minute | Standard Deviation 0.71 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: Day 1 - 30 minutes | -1.0 breaths per minute | Standard Deviation 4.24 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | 23.0 breaths per minute | Standard Deviation 7.07 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Day 1 - 30 minutes | -1.0 breaths per minute | Standard Deviation 1.41 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Day 1 - 2 hours | -1.0 breaths per minute | Standard Deviation 1.41 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Day 1 - 6 hours | -0.5 breaths per minute | Standard Deviation 0.71 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Day 1 - 12 hours | -2.5 breaths per minute | Standard Deviation 4.95 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Follow Up 1 | -3.5 breaths per minute | Standard Deviation 4.95 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: End of Treatment | 2.5 breaths per minute | Standard Deviation 3.54 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Follow Up 2 | -8.0 breaths per minute | — |
| Part 1: 250 mg Placebo 24-hours Continuous 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: Change from Baseline: Day 1 - 12 hours | 0.0 breaths per minute | Standard Deviation 0 |
| Part 1: 250 mg Placebo 24-hours Continuous 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: Change from Baseline: Day 1 - 2 hours | 6.5 breaths per minute | Standard Deviation 7.78 |
| Part 1: 250 mg Placebo 24-hours Continuous 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: Change from Baseline: Follow Up 1 | -4.0 breaths per minute | — |
| Part 1: 250 mg Placebo 24-hours Continuous 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: Change from Baseline: Day 1 - 30 minutes | -0.5 breaths per minute | Standard Deviation 0.71 |
| Part 1: 250 mg Placebo 24-hours Continuous 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 | 20.0 breaths per minute | Standard Deviation 2.83 |
| Part 1: 250 mg Placebo 24-hours Continuous 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: Change from Baseline: Follow Up 2 | -2.0 breaths per minute | Standard Deviation 5.66 |
| Part 1: 250 mg Placebo 24-hours Continuous 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: Change from Baseline: End of Treatment | 7.0 breaths per minute | — |
Primary
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
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Follow Up 3 | -6.8 Breaths per minute | Standard Deviation 5.74 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 4 | -1.8 Breaths per minute | Standard Deviation 3.76 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Follow Up 4 | -6.0 Breaths per minute | Standard Deviation 5.66 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: End of Treatment | -3.3 Breaths per minute | Standard Deviation 4.27 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 2 | -3.0 Breaths per minute | Standard Deviation 7.1 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Follow Up 1 | -3.5 Breaths per minute | Standard Deviation 4.55 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 5 | -2.2 Breaths per minute | Standard Deviation 5.78 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Baseline | 23.5 Breaths per minute | Standard Deviation 3.45 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Follow Up 2 | -5.8 Breaths per minute | Standard Deviation 6.5 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 5 | -2.9 Breaths per minute | Standard Deviation 2.04 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Baseline | 22.4 Breaths per minute | Standard Deviation 5.59 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Follow Up 3 | -10.0 Breaths per minute | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 4 | -4.0 Breaths per minute | Standard Deviation 5.69 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | -3.1 Breaths per minute | Standard Deviation 4.26 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Follow Up 2 | -2.0 Breaths per minute | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Follow Up 1 | -3.9 Breaths per minute | Standard Deviation 4.88 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 2 | -1.7 Breaths per minute | Standard Deviation 7.45 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Follow Up 4 | 1.3 Breaths per minute | Standard Deviation 4.73 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: End of Treatment | -2.3 Breaths per minute | Standard Deviation 5.62 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 2 | -0.5 Breaths per minute | Standard Deviation 5.07 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 4.97 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 4 | 4.0 Breaths per minute | Standard Deviation 5 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 5 | -0.7 Breaths per minute | Standard Deviation 2.08 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: End of Treatment | -2.3 Breaths per minute | Standard Deviation 3.51 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Early Termination | -4.0 Breaths per minute | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Follow Up 1 | -3.0 Breaths per minute | Standard Deviation 1 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Follow Up 2 | -1.5 Breaths per minute | Standard Deviation 2.12 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Follow Up 3 | 1.3 Breaths per minute | Standard Deviation 10.12 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Baseline | 21.0 Breaths per minute | Standard Deviation 4.69 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Follow Up 4 | -3.0 Breaths per minute | — |
Primary
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
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Day 1 - 12 hours | -8.0 mmHg | Standard Deviation 18.38 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Day 1- 30 minutes | 6.0 mmHg | Standard Deviation 18.38 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Day 1 - 2 hours | 12.0 mmHg | Standard Deviation 22.63 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Day 1 - 6 hours | -1.5 mmHg | Standard Deviation 14.85 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Baseline | 116.0 mmHg | Standard Deviation 4.24 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Follow Up 1 | 8.0 mmHg | Standard Deviation 11.31 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Follow Up 2 | 17.0 mmHg | — |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | Diastolic blood pressure: Baseline | 64.0 mmHg | Standard Deviation 9.9 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | Diastolic blood pressure: Change from Baseline: Day 1 - 30 minutes | 5.0 mmHg | Standard Deviation 5.66 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | Diastolic blood pressure: Change from Baseline: Day 1 - 2 hours | 9.5 mmHg | Standard Deviation 12.02 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | Diastolic blood pressure: Change from Baseline: Day 1 - 6 hours | -1.5 mmHg | Standard Deviation 6.36 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | Diastolic blood pressure: Change from Baseline: Day 1 - 12 hours | 9.0 mmHg | Standard Deviation 9.9 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | Diastolic blood pressure: Change from Baseline: End of Treatment | -1.0 mmHg | Standard Deviation 0 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | Diastolic blood pressure: Change from Baseline: Follow Up 1 | 17.0 mmHg | Standard Deviation 2.83 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | Diastolic blood pressure: Change from Baseline: Follow Up 2 | 12.0 mmHg | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | -17.0 mmHg | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Diastolic blood pressure: Baseline | 59.0 mmHg | Standard Deviation 21.21 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Diastolic blood pressure: Change from Baseline: Follow Up 2 | 17.0 mmHg | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Diastolic blood pressure: Change from Baseline: Day 1 - 6 hours | 8.5 mmHg | Standard Deviation 17.68 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Diastolic blood pressure: Change from Baseline: Follow Up 1 | 6.0 mmHg | Standard Deviation 2.83 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Diastolic blood pressure: Change from Baseline: Day 1 - 30 minutes | 16.0 mmHg | Standard Deviation 14.14 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Day 1 - 2 hours | -20.0 mmHg | Standard Deviation 11.31 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Diastolic blood pressure: Change from Baseline: Day 1 - 2 hours | 11.5 mmHg | Standard Deviation 7.78 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Day 1 - 12 hours | -6.5 mmHg | Standard Deviation 26.16 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Follow Up 1 | -16.5 mmHg | Standard Deviation 21.92 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Day 1 - 6 hours | -20.5 mmHg | Standard Deviation 13.44 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Day 1- 30 minutes | -12.5 mmHg | Standard Deviation 12.02 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Diastolic blood pressure: Change from Baseline: Day 1 - 12 hours | 13.0 mmHg | Standard Deviation 16.97 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Follow Up 2 | -20.0 mmHg | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Diastolic blood pressure: Change from Baseline: End of Treatment | 23.0 mmHg | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Baseline | 134.5 mmHg | Standard Deviation 13.44 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | 0.0 mmHg | Standard Deviation 8.49 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Day 1 - 12 hours | -2.5 mmHg | Standard Deviation 4.95 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | Diastolic blood pressure: Change from Baseline: End of Treatment | -7.5 mmHg | Standard Deviation 6.36 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Follow Up 1 | -3.0 mmHg | Standard Deviation 9.9 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Follow Up 2 | -6.0 mmHg | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | Diastolic blood pressure: Change from Baseline: Follow Up 2 | -11.0 mmHg | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | Diastolic blood pressure: Baseline | 68.5 mmHg | Standard Deviation 13.44 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | Diastolic blood pressure: Change from Baseline: Day 1 - 30 minutes | -5.0 mmHg | Standard Deviation 8.49 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | Diastolic blood pressure: Change from Baseline: Follow Up 1 | -6.0 mmHg | Standard Deviation 1.41 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | Diastolic blood pressure: Change from Baseline: Day 1 - 2 hours | -2.0 mmHg | Standard Deviation 4.24 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | Diastolic blood pressure: Change from Baseline: Day 1 - 6 hours | -8.0 mmHg | Standard Deviation 7.07 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Baseline | 108.0 mmHg | Standard Deviation 14.14 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Day 1- 30 minutes | -4.0 mmHg | Standard Deviation 12.73 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | Diastolic blood pressure: Change from Baseline: Day 1 - 12 hours | -8.5 mmHg | Standard Deviation 2.12 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Day 1 - 2 hours | 4.0 mmHg | Standard Deviation 2.83 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Day 1 - 6 hours | 0.0 mmHg | Standard Deviation 7.07 |
| Part 1: 250 mg Placebo 24-hours Continuous 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 | Diastolic blood pressure: Change from Baseline: Follow Up 2 | -2.0 mmHg | Standard Deviation 12.73 |
| Part 1: 250 mg Placebo 24-hours Continuous 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: Follow Up 2 | -14.5 mmHg | Standard Deviation 27.58 |
| Part 1: 250 mg Placebo 24-hours Continuous 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: Day 1 - 2 hours | 3.5 mmHg | Standard Deviation 20.51 |
| Part 1: 250 mg Placebo 24-hours Continuous 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: Baseline | 127.5 mmHg | Standard Deviation 30.41 |
| Part 1: 250 mg Placebo 24-hours Continuous 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 | Diastolic blood pressure: Change from Baseline: End of Treatment | -4.5 mmHg | Standard Deviation 0.71 |
| Part 1: 250 mg Placebo 24-hours Continuous 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: Follow Up 1 | 13.5 mmHg | Standard Deviation 3.54 |
| Part 1: 250 mg Placebo 24-hours Continuous 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 | Diastolic blood pressure: Change from Baseline: Day 1 - 12 hours | -1.0 mmHg | Standard Deviation 0 |
| Part 1: 250 mg Placebo 24-hours Continuous 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: Day 1- 30 minutes | 9.5 mmHg | Standard Deviation 17.68 |
| Part 1: 250 mg Placebo 24-hours Continuous 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: Day 1 - 12 hours | 10.0 mmHg | Standard Deviation 5.66 |
| Part 1: 250 mg Placebo 24-hours Continuous 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 | Diastolic blood pressure: Change from Baseline: Day 1 - 30 minutes | 6.0 mmHg | Standard Deviation 9.9 |
| Part 1: 250 mg Placebo 24-hours Continuous 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 | -1.0 mmHg | Standard Deviation 5.66 |
| Part 1: 250 mg Placebo 24-hours Continuous 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 | Diastolic blood pressure: Change from Baseline: Day 1 - 2 hours | 3.0 mmHg | Standard Deviation 11.31 |
| Part 1: 250 mg Placebo 24-hours Continuous 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 | Diastolic blood pressure: Change from Baseline: Follow Up 1 | 8.5 mmHg | Standard Deviation 2.12 |
| Part 1: 250 mg Placebo 24-hours Continuous 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 | Diastolic blood pressure: Baseline | 76.5 mmHg | Standard Deviation 9.19 |
| Part 1: 250 mg Placebo 24-hours Continuous 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: Day 1 - 6 hours | 16.5 mmHg | Standard Deviation 24.75 |
| Part 1: 250 mg Placebo 24-hours Continuous 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 | Diastolic blood pressure: Change from Baseline: Day 1 - 6 hours | 6.5 mmHg | Standard Deviation 7.78 |
Primary
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
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: End of Treatment | 2.5 mmHg | Standard Deviation 8.96 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: Day 5 | 2.7 mmHg | Standard Deviation 10.05 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | Systolic blood pressure: Change from Baseline: End of Treatment | 3.7 mmHg | Standard Deviation 14.85 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | Systolic blood pressure: Change from Baseline: Day 5 | 3.2 mmHg | Standard Deviation 10.28 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: Follow Up 1 | 4.8 mmHg | Standard Deviation 11.34 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: Day 2 | 4.7 mmHg | Standard Deviation 10.52 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: Follow Up 4 | 11.0 mmHg | Standard Deviation 14.14 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: Follow Up 2 | 15.5 mmHg | Standard Deviation 13.48 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | Systolic blood pressure: Baseline | 105.3 mmHg | Standard Deviation 18.08 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: Follow Up 3 | 13.0 mmHg | Standard Deviation 13.64 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: Day 4 | 2.7 mmHg | Standard Deviation 8.57 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | Systolic blood pressure: Change from Baseline: Follow Up 4 | 15.0 mmHg | Standard Deviation 2.83 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | Systolic blood pressure: Change from Baseline: Day 2 | 4.8 mmHg | Standard Deviation 10.34 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Change from Baseline: Day 3 | 7.8 mmHg | Standard Deviation 10.96 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | Systolic blood pressure: Change from Baseline: Follow Up 3 | 19.0 mmHg | Standard Deviation 14.07 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | Systolic blood pressure: Change from Baseline: Day 3 | 15.5 mmHg | Standard Deviation 14.15 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | Systolic blood pressure: Change from Baseline: Follow Up 2 | 21.5 mmHg | Standard Deviation 17.62 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | Systolic blood pressure: Change from Baseline: Day 4 | -1.2 mmHg | Standard Deviation 12.54 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 | Systolic blood pressure: Change from Baseline: Follow Up 1 | 5.0 mmHg | Standard Deviation 14.14 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: Day 2 | -2.4 mmHg | Standard Deviation 7.48 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: Day 3 | -9.4 mmHg | Standard Deviation 13.15 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: Day 4 | -7.4 mmHg | Standard Deviation 9.32 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: Day 5 | -9.6 mmHg | Standard Deviation 11.62 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Systolic blood pressure: Baseline | 127.6 mmHg | Standard Deviation 13.64 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Systolic blood pressure: Change from Baseline: Day 2 | 1.4 mmHg | Standard Deviation 14.2 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Systolic blood pressure: Change from Baseline: Day 3 | -4.9 mmHg | Standard Deviation 16.92 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: End of Treatment | -7.9 mmHg | Standard Deviation 17 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: Follow Up 1 | -6.7 mmHg | Standard Deviation 13.86 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: Follow Up 2 | -34.0 mmHg | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: Follow Up 3 | -14.5 mmHg | Standard Deviation 13.44 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Change from Baseline: Follow Up 4 | -4.3 mmHg | Standard Deviation 12.66 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Systolic blood pressure: Change from Baseline: Day 4 | -13.1 mmHg | Standard Deviation 13.59 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Systolic blood pressure: Change from Baseline: Day 5 | -4.6 mmHg | Standard Deviation 14.14 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Systolic blood pressure: Change from Baseline: End of Treatment | -11.6 mmHg | Standard Deviation 12.71 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Systolic blood pressure: Change from Baseline: Follow Up 1 | -7.7 mmHg | Standard Deviation 10.83 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Systolic blood pressure: Change from Baseline: Follow Up 2 | 1.0 mmHg | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Systolic blood pressure: Change from Baseline: Follow Up 3 | -1.0 mmHg | Standard Deviation 2.83 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | Systolic blood pressure: Change from Baseline: Follow Up 4 | -2.7 mmHg | Standard Deviation 6.66 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | 78.7 mmHg | Standard Deviation 7.87 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | Systolic blood pressure: Change from Baseline: Day 5 | -12.3 mmHg | Standard Deviation 6.66 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: End of Treatment | -13.0 mmHg | Standard Deviation 2 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | Systolic blood pressure: Change from Baseline: Follow Up 4 | 15.0 mmHg | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | Systolic blood pressure: Change from Baseline: End of Treatment | -11.0 mmHg | Standard Deviation 6.08 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | Systolic blood pressure: Change from Baseline: Early Termination | 11.0 mmHg | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Day 5 | 2.0 mmHg | Standard Deviation 11.27 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Day 4 | -11.7 mmHg | Standard Deviation 4.93 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | Systolic blood pressure: Change from Baseline: Follow Up 1 | 4.5 mmHg | Standard Deviation 17.29 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | Systolic blood pressure: Change from Baseline: Day 3 | 10.8 mmHg | Standard Deviation 24.7 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Day 2 | 1.0 mmHg | Standard Deviation 9.83 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | Systolic blood pressure: Change from Baseline: Follow Up 2 | 24.0 mmHg | Standard Deviation 48.08 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | Systolic blood pressure: Change from Baseline: Day 2 | -4.3 mmHg | Standard Deviation 8.42 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Follow Up 2 | -3.0 mmHg | Standard Deviation 1.41 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | 72.0 mmHg | Standard Deviation 12.52 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Follow Up 3 | 5.0 mmHg | Standard Deviation 21.63 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Follow Up 1 | -5.8 mmHg | Standard Deviation 12.04 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | Systolic blood pressure: Change from Baseline: Follow Up 3 | 11.7 mmHg | Standard Deviation 17.01 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Follow Up 4 | 12.0 mmHg | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | Systolic blood pressure: Baseline | 116.5 mmHg | Standard Deviation 14.29 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | Systolic blood pressure: Change from Baseline: Day 4 | -18.0 mmHg | Standard Deviation 6 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Early Termination | 11.0 mmHg | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Change from Baseline: Day 3 | 2.3 mmHg | Standard Deviation 9.54 |
Primary
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
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Baseline | 37.6 Degree Celsius | Standard Deviation 0.14 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 - 2 hours | 0.1 Degree Celsius | Standard Deviation 0.49 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 - 6 hours | -0.4 Degree Celsius | Standard Deviation 0.28 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 - 12 hours | -0.1 Degree Celsius | Standard Deviation 0.99 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: End of Treatment | -0.7 Degree Celsius | Standard Deviation 0.64 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Follow Up 1 | -0.9 Degree Celsius | Standard Deviation 0.78 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Follow Up 2 | -0.9 Degree Celsius | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: End of Treatment | -0.1 Degree Celsius | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 - 12 hours | -0.5 Degree Celsius | Standard Deviation 0.14 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Follow Up 2 | 2.0 Degree Celsius | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Follow Up 1 | -0.7 Degree Celsius | Standard Deviation 0.07 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 - 6 hours | 0.0 Degree Celsius | Standard Deviation 0.14 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 - 2 hours | -0.1 Degree Celsius | Standard Deviation 0.07 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Baseline | 37.0 Degree Celsius | Standard Deviation 0.28 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Follow Up 1 | 0.3 Degree Celsius | Standard Deviation 0.07 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 - 2 hours | 0.1 Degree Celsius | Standard Deviation 0.14 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 - 6 hours | 0.2 Degree Celsius | Standard Deviation 0.07 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 - 12 hours | 0.1 Degree Celsius | Standard Deviation 0 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: End of Treatment | 0.3 Degree Celsius | Standard Deviation 0.35 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Follow Up 2 | 0.3 Degree Celsius | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Baseline | 36.5 Degree Celsius | Standard Deviation 0.14 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | 0.1 Degree Celsius | Standard Deviation 0.07 |
| Part 1: 250 mg Placebo 24-hours Continuous 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 - 2 hours | -0.1 Degree Celsius | Standard Deviation 0.57 |
| Part 1: 250 mg Placebo 24-hours Continuous 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 - 6 hours | 0.1 Degree Celsius | Standard Deviation 0.71 |
| Part 1: 250 mg Placebo 24-hours Continuous 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 |
| Part 1: 250 mg Placebo 24-hours Continuous 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: Baseline | 37.1 Degree Celsius | Standard Deviation 0.99 |
| Part 1: 250 mg Placebo 24-hours Continuous 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 - 12 hours | 0.7 Degree Celsius | Standard Deviation 0.42 |
| Part 1: 250 mg Placebo 24-hours Continuous 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: Follow Up 2 | 0.1 Degree Celsius | Standard Deviation 0.35 |
| Part 1: 250 mg Placebo 24-hours Continuous 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: Follow Up 1 | -0.3 Degree Celsius | Standard Deviation 0.85 |
| Part 1: 250 mg Placebo 24-hours Continuous 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: End of Treatment | 0.3 Degree Celsius | Standard Deviation 0.64 |
Primary
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
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 2 | -0.4 Degree Celsius | Standard Deviation 0.88 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 5 | -0.4 Degree Celsius | Standard Deviation 0.97 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 3 | -0.2 Degree Celsius | Standard Deviation 0.84 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Follow Up 1 | -0.4 Degree Celsius | Standard Deviation 0.91 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Follow Up 4 | -1.0 Degree Celsius | Standard Deviation 0.64 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Follow Up 2 | -0.1 Degree Celsius | Standard Deviation 1.21 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: End of Treatment | -0.4 Degree Celsius | Standard Deviation 0.91 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Follow Up 3 | -0.4 Degree Celsius | Standard Deviation 1.05 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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: Baseline | 36.7 Degree Celsius | Standard Deviation 0.79 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: End of Treatment | -0.6 Degree Celsius | Standard Deviation 0.59 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 2 | -0.3 Degree Celsius | Standard Deviation 0.5 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Follow Up 1 | -0.6 Degree Celsius | Standard Deviation 0.46 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | -0.4 Degree Celsius | Standard Deviation 0.45 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 3 | -0.3 Degree Celsius | Standard Deviation 0.43 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 5 | -0.6 Degree Celsius | Standard Deviation 0.6 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Follow Up 3 | -0.1 Degree Celsius | Standard Deviation 0.21 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Baseline | 36.7 Degree Celsius | Standard Deviation 0.35 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Follow Up 2 | -0.1 Degree Celsius | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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: Follow Up 4 | 0.2 Degree Celsius | Standard Deviation 0.67 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Follow Up 4 | -0.2 Degree Celsius | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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 | 0.0 Degree Celsius | Standard Deviation 0.4 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 5 | 0.4 Degree Celsius | Standard Deviation 0.55 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: End of Treatment | 0.5 Degree Celsius | Standard Deviation 0.45 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Early Termination | -0.3 Degree Celsius | — |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Follow Up 1 | 0.7 Degree Celsius | Standard Deviation 0.17 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Follow Up 2 | 0.7 Degree Celsius | Standard Deviation 0.57 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Baseline | 36.3 Degree Celsius | Standard Deviation 0.73 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 2 | 0.2 Degree Celsius | Standard Deviation 0.29 |
| Part 1: 500 mg Placebo 24-hours Continuous 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 3 | 0.1 Degree Celsius | Standard Deviation 0.43 |
| Part 1: 500 mg Placebo 24-hours Continuous 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: Follow Up 3 | 0.7 Degree Celsius | Standard Deviation 1.08 |
Secondary
PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameter: Concentration at 120 Hours (End of Infusion) - Part 2: MAD
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.
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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-00835231 | 1338 ng/mL | Geometric Coefficient of Variation 84 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 | 91.64 ng/mL | Geometric Coefficient of Variation 51 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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-00835231 | 800.8 ng/mL | Geometric Coefficient of Variation 19 |
Secondary
PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameters: Concentration at 24 Hours (End of Infusion) - Part 1: SAD
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.
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 |
| Part 1: PF-07304814 500 mg 24-hours Continuous 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-00835231 | NA ng/mL |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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 |
| Part 1: PF-07304814 250 mg 24-hours Continuous 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-00835231 | NA ng/mL |
Secondary
PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameters: Concentration at Steady State (Css) - Part 2: MAD
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.
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | 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 |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameters: Concentration at Steady State (Css) - Part 2: MAD | Css of PF-07304814 | 102.2 ng/mL | Geometric Coefficient of Variation 35 |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameters: Concentration at Steady State (Css) - Part 2: MAD | Css of PF-00835231 | 970.2 ng/mL | Geometric Coefficient of Variation 16 |
Secondary
PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameters: Maximum Observed Concentration (Cmax) - Part 2: MAD
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.
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: PF-07304814 500 mg 24-hours Continuous 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 |
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | 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 |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameters: Maximum Observed Concentration (Cmax) - Part 2: MAD | Cmax of PF-07304814 | 272.6 ng/mL | Geometric Coefficient of Variation 281 |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameters: Maximum Observed Concentration (Cmax) - Part 2: MAD | Cmax of PF-00835231 | 1265 ng/mL | Geometric Coefficient of Variation 20 |
Secondary
PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameters: t½ - Part 2: MAD
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameters: t½ - Part 2: MAD | t½ of PF-00835231 | 1.79 hour | — |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameters: t½ - Part 2: MAD | t½ of PF-00835231 | 2.317 hour | Standard Deviation 0.96547 |
| Unknown | PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameters: t½ - Part 2: MAD | t½ of PF-07304814 | — hour | — |