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This is the first time PF-07242813 will be given to humans. The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of escalating single and repeat doses of PF-07242813 in healthy participants and in participants with moderate to severe atopic dermatitis. An additional goal is to assess the pharmacodynamics of PF-07242813 in participants with moderate to severe AD, including potential effects on clinical signs and symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single ascending doses of PF-07242813 or placebo in healthy participants | Experimental | Participants will receive a single intravenous dose of either PF-07242813 or placebo |
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| Multiple ascending doses of PF-07242813 or placebo in healthy participants | Experimental | Participants will receive multiple subcutaneous doses PF-07242813 or placebo |
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| Single dose of PF-07242813 or placebo in participants with moderate to severe atopic dermatitis | Experimental | Participants will receive a single intravenous dose of either PF-07242813 or placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07242813 | Drug | PF-07242813 given intravenously or subcutaneous |
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| Measure | Description | Time Frame |
|---|---|---|
| Part 1: SAD Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or other important medical events. An AE was considered as treatment emergent if the event started during the effective duration of treatment. All events that started on or after the first dosing day up to the last dose plus the lag time were considered as TEAEs. | From start of study treatment on Day 1 to Day 71 |
| Part 1: MAD Cohorts: Number of Participants With TEAEs and TESAEs | An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or other important medical events. An AE was considered as treatment emergent if the event started during the effective duration of treatment. All events that started on or after the first dosing day up to the last dose plus the lag time were considered as TEAEs. | From start of study treatment on Day 1 to Day 99 |
| Part 2: Number of Participants With TEAEs and TESAEs | An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or other important medical events. An AE was considered as treatment emergent if the event started during the effective duration of treatment. All events that started on or after the first dosing day up to the last dose plus the lag time were considered as TEAEs. |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: SAD Cohorts: Area Under the Serum Concentration Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) for PF-07242813 | AUClast was calculated using the linear/log trapezoidal method. | Pre-dose, 2, 6, 12, 24, 48, 72, 96, 336, 672 hours post-dose (for all cohorts); 1008 hours post-dose for all cohorts except 0.3 mg IV; 1344 and 1680 hours post-dose for all cohorts except 0.3 mg IV and 1 mg IV |
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Inclusion Criteria Part 1 (Healthy Volunteer Cohorts):
Inclusion Criteria Part 2 (Atopic Dermatitis Cohort):
Exclusion Criteria Part 1 (Healthy Volunteer Cohorts):
Exclusion Criteria Part 2 (Atopic Dermatitis Cohort):
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials, LLC | Anaheim | California | 92801 | United States | ||
| First OC Dermatology |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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A total of 122 participants (57 participants in single ascending dose [SAD] cohorts, 40 in multiple ascending dose [MAD] cohorts and 25 in AD cohorts) were enrolled across 5 centers in the United States.
The study was conducted in 2 parts: Part 1 was conducted in healthy adult participants and Part 2 was conducted in adult participants with moderate to severe atopic dermatitis (AD).
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: 0.3 mg IV SAD | Healthy participants were administered a single dose of 0.3 milligrams (mg) PF-07242813 as an intravenous (IV) infusion. |
| FG001 | Part 1: 1mg IV SAD | Healthy participants were administered a single dose of 1 mg PF-07242813 as an intravenous (IV) infusion. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part 1: Treatment Phase |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 10, 2021 | Dec 4, 2023 |
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| Placebo | Drug | Placebo given intravenously or subcutaneous |
|
| From start of study treatment on Day 1 to Week 16 |
| Part 1: SAD Cohorts: Number of Participants With Clinically Significant Findings in Vital Signs | Vital signs included blood pressure, pulse rate, respiratory rate and temperature. Temperature was measured by oral, tympanic, or temporal artery method. Blood pressure and respiratory rate were measured with the participant in a supine position after 5 minutes of rest for the participant. Clinically significant findings were determined by the investigator. | From initiation of treatment to day 71 |
| Part 1: MAD Cohorts: Number of Participants With Clinically Significant Findings in Vital Signs | Vital signs included blood pressure, pulse rate, respiratory rate and temperature. Temperature was measured by oral, tympanic, or temporal artery method. Blood pressure and respiratory rate were measured with the participant in a supine position after 5 minutes of rest for the participant. Clinically significant findings were determined by the investigator. | From start of study treatment on Day 1 to Day 99 |
| Part 2: Number of Participants With Clinically Significant Findings in Vital Signs | Vital signs included blood pressure, pulse rate, respiratory rate and temperature. Temperature was measured by oral, tympanic, or temporal artery method. Blood pressure and respiratory rate were measured with the participant in a supine position after 5 minutes of rest for the participant. Clinically significant findings were determined by the investigator. | From start of study treatment on Day 1 to Week 16 |
| Part 1: SAD Cohorts: Number of Participants With Laboratory Test Abnormalities | Pre-defined criteria for laboratory parameters were hemoglobin (HGB) (<0.8* Lower limit normal (LLN)), Erythrocyte (Ery). Mean Corpuscular (MC) Volume (<0.9* LLN), Ery MC Hemoglobin (<0.9* LLN), Ery. MC HGB Concentration (<0.9* LLN), Leukocytes (<0.6* LLN), Neutrophils (<0.8* LLN), Bilirubin (>1.5* Upper limit normal (ULN)), Aspartate Aminotransferase (>3.0* ULN), Urea Nitrogen (>1.3* ULN), Creatinine (>1.3* ULN), Urate (>1.2* ULN). Number of participants with any laboratory test abnormalities meeting pre-defined criteria was reported in this outcome measure. | Baseline (last pre-dose measurement) to Day 71 |
| Part 1: MAD Cohorts: Number of Participants With Laboratory Test Abnormalities | Pre-defined criteria for laboratory parameters were HGB (<0.8* LLN), Ery MCV (<0.9* LLN), Ery MC Hemoglobin (<0.9* LLN), Ery. MC HGB Concentration (<0.9* LLN), Leukocytes (<0.6* LLN), Neutrophils (<0.8* LLN), Bilirubin (>1.5* ULN), Aspartate Aminotransferase (>3.0* ULN), Urea Nitrogen (>1.3* ULN), Creatinine (>1.3* ULN), Urate (>1.2* ULN). Number of participants with any laboratory test abnormalities meeting pre-defined criteria was reported in this outcome measure. | Baseline (last pre-dose measurement) to Day 99 |
| Part 2: Number of Participants With Laboratory Test Abnormalities | Pre-defined criteria for laboratory parameters were HGB (<0.8* LLN), Ery MCV (<0.9* LLN), Ery MC Hemoglobin (<0.9* LLN), Ery. MC HGB Concentration (<0.9* LLN), Leukocytes (<0.6* LLN), Neutrophils (<0.8* LLN), Bilirubin (>1.5* ULN), Aspartate Aminotransferase (>3.0* ULN), Urea Nitrogen (>1.3* ULN), Creatinine (>1.3* ULN), Urate (>1.2* ULN). Number of participants with any laboratory test abnormalities meeting pre-defined criteria was reported in this outcome measure. | Baseline (last pre-dose measurement) to Week 16 |
| Part 1: SAD Cohorts Only: Number of Participants With Cardiac Telemetry Abnormalities | Cardiac telemetry was collected in Part 1 SAD cohorts only. Number of participants with any cardiac telemetry abnormalities were reported in this outcome measure. | From pre-dose up to 6 hours post dose on Day 1 |
| Part 1: SAD Cohorts: Number of Participants With Clinically Significant Findings in Electrocardiogram (ECG) | Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, corrected QT (QTc) intervals and QRS complex. ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. Clinically significant findings were determined by the investigator. | From pre-dose on Day 1 up to Day 71 |
| Part 1: MAD Cohorts: Number of Participants With Clinically Significant Findings in ECG | Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, QTc intervals and QRS complex. ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. Clinically significant findings were determined by the investigator. | From pre-dose on Day 1 up to Day 99 |
| Part 2: Number of Participants With Clinically Significant Findings in ECG | Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, QTc intervals and QRS complex. ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. Clinically significant findings were determined by the investigator. | From pre-dose on week 1 to week 16 |
| Part 1: SAD Cohorts: Area Under the Serum Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) for PF-07242813 | AUCinf was determined as AUClast + (Clast divided by kel), where Clast = predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel= terminal phase rate constant. | Pre-dose, 2, 6, 12, 24, 48, 72, 96, 336, 672 hours post-dose (for all cohorts); 1008 hours post-dose for all cohorts except 0.3 mg IV; 1344 and 1680 hours post-dose for all cohorts except 0.3 mg IV and 1 mg IV |
| Part 1: SAD Cohorts: Maximum Serum Concentration (Cmax) for PF-07242813 | Pre-dose, 2, 6, 12, 24, 48, 72, 96, 336, 672 hours post-dose (for all cohorts); 1008 hours post-dose for all cohorts except 0.3 mg IV; 1344 and 1680 hours post-dose for all cohorts except 0.3 mg IV and 1 mg IV |
| Part 1: SAD Cohorts: Time to Reach Maximum Concentration (Tmax) for PF-07242813 | Pre-dose, 2, 6, 12, 24, 48, 72, 96, 336, 672 hours post-dose (for all cohorts); 1008 hours post-dose for all cohorts except 0.3 mg IV; 1344 and 1680 hours post-dose for all cohorts except 0.3 mg IV and 1 mg IV |
| Part 1: SAD Cohorts: Terminal Elimination Half Life (t1/2) for PF-07242813 | t1/2 was determined by "Loge(2)/kel", where kel was the terminal phase rate constant calculated by a linear regression of the loglinear -concentration time- curve. | Pre-dose, 2, 6, 12, 24, 48, 72, 96, 336, 672 hours post-dose (for all cohorts); 1008 hours post-dose for all cohorts except 0.3 mg IV; 1344 and 1680 hours post-dose for all cohorts except 0.3 mg IV and 1 mg IV |
| Part 1: MAD Cohorts: Area Under the Serum Concentration Time Profile Over the Dosing Interval (AUCtau) for PF-07242813 | Area under the serum concentration time- profile over the dosing interval tau where tau=2 weeks (336 hours). | Day 1,15,29(Pre-dose,2,6,12,24,48,72,96 hours post-dose) Day 15,29(168hours post-dose) Day 29(336hours post-dose) (For all cohorts); Day 1(168hours post-dose for all except 15mg and 50 mg post-dose) |
| Part 1: MAD Cohorts: Cmax for PF-07242813 | Day 1,15,29(Pre-dose,2,6,12,24,48,72,96 hours post-dose) Day 15,29(168hours post-dose) Day 29(336,672,1008,1344,1680hours post-dose) (For all cohorts); Day 1(168hours post-dose for all except 15mg and 50 mg post-dose) |
| Part 1: MAD Cohorts: Tmax for PF-07242813 | Day 1,15,29(Pre-dose,2,6,12,24,48,72,96 hours post-dose) Day 15,29(168hours post-dose) Day 29(336,672,1008,1344,1680hours post-dose) (For all cohorts); Day 1(168hours post-dose for all except 15mg and 50 mg post-dose) |
| Part 1: MAD Cohorts: Terminal Elimination Half Life (t1/2) for PF-07242813 | t1/2 was determined by "Loge(2) per kel", where kel was the terminal phase rate constant calculated by a linear regression of the log/linear -concentration time- curve. | Day 1,15,29(Pre-dose,2,6,12,24,48,72,96 hours post-dose) Day 15,29(168hours post-dose) Day 29(336,672,1008,1344,1680hours post-dose) (For all cohorts); Day 1(168hours post-dose for all except 15mg and 50 mg post-dose) |
| Part 2: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6 | EASI quantifies severity of AD based on severity of lesion clinical signs and percentage (%) of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema, induration/papulation, excoriation and lichenification) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin)] and lower limbs [including buttocks]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, with higher scores indicating greater severity of AD. | Baseline, Week 6 |
| Fountain Valley |
| California |
| 92708 |
| United States |
| Keck School of Medicine of USC | Los Angeles | California | 90033 | United States |
| USC/Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
| Orange County Research Center | Tustin | California | 92780 | United States |
| Vital Prospects Clinical Research Institute, PC | Tulsa | Oklahoma | 74136 | United States |
| Aspen Clinical Research | Orem | Utah | 84058 | United States |
| FG002 | Part 1: 3 mg IV SAD | Healthy participants were administered a single dose of 3 mg PF-07242813 as an intravenous (IV) infusion. |
| FG003 | Part 1: 10 mg IV SAD | Healthy participants were administered a single dose of 10 mg PF-07242813 as an intravenous (IV) infusion. |
| FG004 | Part 1: 30 mg IV SAD | Healthy participants were administered a single dose of 30 mg PF-07242813 as an intravenous (IV) infusion. |
| FG005 | Part 1: 100 mg IV SAD | Healthy participants were administered a single dose of 100 mg PF-07242813 as an intravenous (IV) infusion. |
| FG006 | Part 1: 300 mg IV SAD | Healthy participants were administered a single dose of 300 mg PF-07242813 as an intravenous (IV) infusion. |
| FG007 | Part 1: 1000 mg IV SAD | Healthy participants were administered a single dose of 1000 mg PF-07242813 as an intravenous (IV) infusion. |
| FG008 | Part 1: 1000 mg IV SAD (Japanese Cohort) | Healthy Japanese participants were administered a single dose of 1000 mg PF-07242813 as an IV infusion. |
| FG009 | Part 1: 15 mg SC Q2W MAD | Healthy participants were administered 15 mg PF-07242813 subcutaneously every 2 weeks (Q2W) for a total of 3 doses. |
| FG010 | Part 1: 50 mg SC Q2W MAD | Healthy participants were administered 50 mg PF-07242813 subcutaneously every 2 weeks (Q2W) for a total of 3 doses. |
| FG011 | Part 1: 150 mg SC Q2W MAD | Healthy participants were administered 150 mg PF-07242813 subcutaneously every 2 weeks (Q2W) for a total of 3 doses. |
| FG012 | Part 1: 300 mg SC Q2W MAD | Healthy participants were administered 300 mg PF-07242813 subcutaneously every 2 weeks (Q2W) for a total of 3 doses. |
| FG013 | Part 1: 500 mg IV Q2W MAD | Healthy participants were administered 500 mg PF-07242813 as IV infusion every 2 weeks (Q2W) for a total of 3 doses. |
| FG014 | Part 1: Placebo SAD | Healthy participants were administered a single dose of placebo as an IV infusion. |
| FG015 | Part 1: Placebo SC MAD | Healthy participants were administered placebo every 2 weeks (Q2W) for a total of 3 doses via the SC route. |
| FG016 | Part 1: Placebo IV MAD | Healthy participants were administered placebo every 2 weeks (Q2W) for a total of 3 doses as an IV infusion. |
| FG017 | Part 2: 1000 mg IV AD | Participants with atopic dermatitis were administered a single dose of 1000 mg PF-07242813 administered as an IV Infusion. |
| FG018 | Part 2: Placebo IV AD | Participants with atopic dermatitis were administered a single dose of placebo as an IV infusion. |
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| NOT COMPLETED |
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| Part 1: Follow-Up |
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| Part 2: Treatment Phase |
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| Part 2: Follow-Up |
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Safety analysis set consisted of all participants randomly assigned to study intervention and who received at least one dose of study intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: 0.3 mg IV SAD | Healthy participants were administered a single dose of 0.3 milligrams (mg) PF-07242813 as an intravenous (IV) infusion. |
| BG001 | Part 1: 1mg IV SAD | Healthy participants were administered a single dose of 1 mg PF-07242813 as an intravenous (IV) infusion. |
| BG002 | Part 1: 3 mg IV SAD | Healthy participants were administered a single dose of 3 mg PF-07242813 as an intravenous (IV) infusion. |
| BG003 | Part 1: 10 mg IV SAD | Healthy participants were administered a single dose of 10 mg PF-07242813 as an intravenous (IV) infusion. |
| BG004 | Part 1: 30 mg IV SAD | Healthy participants were administered a single dose of 30 mg PF-07242813 as an intravenous (IV) infusion. |
| BG005 | Part 1: 100 mg IV SAD | Healthy participants were administered a single dose of 100 mg PF-07242813 as an intravenous (IV) infusion. |
| BG006 | Part 1: 300 mg IV SAD | Healthy participants were administered a single dose of 300 mg PF-07242813 as an intravenous (IV) infusion. |
| BG007 | Part 1: 1000 mg IV SAD | Healthy participants were administered a single dose of 1000 mg PF-07242813 as an intravenous (IV) infusion. |
| BG008 | Part 1: 1000 mg IV SAD (Japanese Cohort) | Healthy Japanese participants were administered a single dose of 1000 mg PF-07242813 as an IV infusion. |
| BG009 | Part 1: 15 mg SC Q2W MAD | Healthy participants were administered 15 mg PF-07242813 subcutaneously every 2 weeks (Q2W) for a total of 3 doses. |
| BG010 | Part 1: 50 mg SC Q2W MAD | Healthy participants were administered 50 mg PF-07242813 subcutaneously every 2 weeks (Q2W) for a total of 3 doses. |
| BG011 | Part 1: 150 mg SC Q2W MAD | Healthy participants were administered 150 mg PF-07242813 subcutaneously every 2 weeks (Q2W) for a total of 3 doses. |
| BG012 | Part 1: 300 mg SC Q2W MAD | Healthy participants were administered 300 mg PF-07242813 subcutaneously every 2 weeks (Q2W) for a total of 3 doses. |
| BG013 | Part 1: 500 mg IV Q2W MAD | Healthy participants were administered 500 mg PF-07242813 as IV infusion every 2 weeks (Q2W) for a total of 3 doses. |
| BG014 | Part 1: Placebo SAD | Healthy participants were administered a single dose of placebo as an IV infusion. |
| BG015 | Part 1: Placebo SC MAD | Healthy participants were administered placebo every 2 weeks (Q2W) for a total of 3 doses via the SC route. |
| BG016 | Part 1: Placebo IV MAD | Healthy participants were administered placebo every 2 weeks (Q2W) for a total of 3 doses as an IV infusion. |
| BG017 | Part 2: 1000 mg IV AD | Participants with atopic dermatitis were administered a single dose of 1000 mg PF-07242813 administered as an IV Infusion. |
| BG018 | Part 2: Placebo IV AD | Participants with atopic dermatitis were administered a single dose of placebo as an IV infusion. |
| BG019 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||
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| Primary | Part 1: SAD Cohorts: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or other important medical events. An AE was considered as treatment emergent if the event started during the effective duration of treatment. All events that started on or after the first dosing day up to the last dose plus the lag time were considered as TEAEs. | Safety analysis set consisted of all participants randomly assigned to study intervention and who received at least one dose of study intervention. | Posted | Count of Participants | Participants | From start of study treatment on Day 1 to Day 71 |
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| Primary | Part 1: MAD Cohorts: Number of Participants With TEAEs and TESAEs | An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or other important medical events. An AE was considered as treatment emergent if the event started during the effective duration of treatment. All events that started on or after the first dosing day up to the last dose plus the lag time were considered as TEAEs. | Safety analysis set consisted of all participants randomly assigned to study intervention and who received at least one dose of study intervention. | Posted | Count of Participants | Participants | From start of study treatment on Day 1 to Day 99 |
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| Primary | Part 2: Number of Participants With TEAEs and TESAEs | An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or other important medical events. An AE was considered as treatment emergent if the event started during the effective duration of treatment. All events that started on or after the first dosing day up to the last dose plus the lag time were considered as TEAEs. | Safety analysis set consisted of all participants randomly assigned to study intervention and who received at least one dose of study intervention. | Posted | Count of Participants | Participants | From start of study treatment on Day 1 to Week 16 |
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| Primary | Part 1: SAD Cohorts: Number of Participants With Clinically Significant Findings in Vital Signs | Vital signs included blood pressure, pulse rate, respiratory rate and temperature. Temperature was measured by oral, tympanic, or temporal artery method. Blood pressure and respiratory rate were measured with the participant in a supine position after 5 minutes of rest for the participant. Clinically significant findings were determined by the investigator. | Safety analysis set consisted of all participants randomly assigned to study intervention and who received at least one dose of study intervention. | Posted | Count of Participants | Participants | From initiation of treatment to day 71 |
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| Primary | Part 1: MAD Cohorts: Number of Participants With Clinically Significant Findings in Vital Signs | Vital signs included blood pressure, pulse rate, respiratory rate and temperature. Temperature was measured by oral, tympanic, or temporal artery method. Blood pressure and respiratory rate were measured with the participant in a supine position after 5 minutes of rest for the participant. Clinically significant findings were determined by the investigator. | Safety analysis set consisted of all participants randomly assigned to study intervention and who received at least one dose of study intervention. | Posted | Count of Participants | Participants | From start of study treatment on Day 1 to Day 99 |
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| Primary | Part 2: Number of Participants With Clinically Significant Findings in Vital Signs | Vital signs included blood pressure, pulse rate, respiratory rate and temperature. Temperature was measured by oral, tympanic, or temporal artery method. Blood pressure and respiratory rate were measured with the participant in a supine position after 5 minutes of rest for the participant. Clinically significant findings were determined by the investigator. | Safety analysis set consisted of all participants randomly assigned to study intervention and who received at least one dose of study intervention. | Posted | Count of Participants | Participants | From start of study treatment on Day 1 to Week 16 |
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| Primary | Part 1: SAD Cohorts: Number of Participants With Laboratory Test Abnormalities | Pre-defined criteria for laboratory parameters were hemoglobin (HGB) (<0.8* Lower limit normal (LLN)), Erythrocyte (Ery). Mean Corpuscular (MC) Volume (<0.9* LLN), Ery MC Hemoglobin (<0.9* LLN), Ery. MC HGB Concentration (<0.9* LLN), Leukocytes (<0.6* LLN), Neutrophils (<0.8* LLN), Bilirubin (>1.5* Upper limit normal (ULN)), Aspartate Aminotransferase (>3.0* ULN), Urea Nitrogen (>1.3* ULN), Creatinine (>1.3* ULN), Urate (>1.2* ULN). Number of participants with any laboratory test abnormalities meeting pre-defined criteria was reported in this outcome measure. | Safety analysis set consisted of all participants randomly assigned to study intervention and who received at least one dose of study intervention. | Posted | Count of Participants | Participants | Baseline (last pre-dose measurement) to Day 71 |
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| Primary | Part 1: MAD Cohorts: Number of Participants With Laboratory Test Abnormalities | Pre-defined criteria for laboratory parameters were HGB (<0.8* LLN), Ery MCV (<0.9* LLN), Ery MC Hemoglobin (<0.9* LLN), Ery. MC HGB Concentration (<0.9* LLN), Leukocytes (<0.6* LLN), Neutrophils (<0.8* LLN), Bilirubin (>1.5* ULN), Aspartate Aminotransferase (>3.0* ULN), Urea Nitrogen (>1.3* ULN), Creatinine (>1.3* ULN), Urate (>1.2* ULN). Number of participants with any laboratory test abnormalities meeting pre-defined criteria was reported in this outcome measure. | Safety analysis set consisted of all participants randomly assigned to study intervention and who received at least one dose of study intervention. | Posted | Count of Participants | Participants | Baseline (last pre-dose measurement) to Day 99 |
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| Primary | Part 2: Number of Participants With Laboratory Test Abnormalities | Pre-defined criteria for laboratory parameters were HGB (<0.8* LLN), Ery MCV (<0.9* LLN), Ery MC Hemoglobin (<0.9* LLN), Ery. MC HGB Concentration (<0.9* LLN), Leukocytes (<0.6* LLN), Neutrophils (<0.8* LLN), Bilirubin (>1.5* ULN), Aspartate Aminotransferase (>3.0* ULN), Urea Nitrogen (>1.3* ULN), Creatinine (>1.3* ULN), Urate (>1.2* ULN). Number of participants with any laboratory test abnormalities meeting pre-defined criteria was reported in this outcome measure. | Safety analysis set consisted of all participants randomly assigned to study intervention and who received at least one dose of study intervention. | Posted | Count of Participants | Participants | Baseline (last pre-dose measurement) to Week 16 |
|
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| Primary | Part 1: SAD Cohorts Only: Number of Participants With Cardiac Telemetry Abnormalities | Cardiac telemetry was collected in Part 1 SAD cohorts only. Number of participants with any cardiac telemetry abnormalities were reported in this outcome measure. | Safety analysis set consisted of all participants randomly assigned to study intervention and who received at least one dose of study intervention. This outcome was planned to be analyzed for SAD cohorts only as pre-specified in protocol. | Posted | Count of Participants | Participants | From pre-dose up to 6 hours post dose on Day 1 |
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| Primary | Part 1: SAD Cohorts: Number of Participants With Clinically Significant Findings in Electrocardiogram (ECG) | Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, corrected QT (QTc) intervals and QRS complex. ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. Clinically significant findings were determined by the investigator. | Safety analysis set consisted of all participants randomly assigned to study intervention and who received at least one dose of study intervention. | Posted | Count of Participants | Participants | From pre-dose on Day 1 up to Day 71 |
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| Primary | Part 1: MAD Cohorts: Number of Participants With Clinically Significant Findings in ECG | Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, QTc intervals and QRS complex. ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. Clinically significant findings were determined by the investigator. | Safety analysis set consisted of all participants randomly assigned to study intervention and who received at least one dose of study intervention. | Posted | Count of Participants | Participants | From pre-dose on Day 1 up to Day 99 |
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| Primary | Part 2: Number of Participants With Clinically Significant Findings in ECG | Twelve lead ECGs were obtained using an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, QTc intervals and QRS complex. ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. Clinically significant findings were determined by the investigator. | Safety analysis set consisted of all participants randomly assigned to study intervention and who received at least one dose of study intervention. | Posted | Count of Participants | Participants | From pre-dose on week 1 to week 16 |
|
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| Secondary | Part 1: SAD Cohorts: Area Under the Serum Concentration Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) for PF-07242813 | AUClast was calculated using the linear/log trapezoidal method. | The PK parameter set consisted of all randomized participants who received at least 1 dose of study intervention and who have at least 1 of the PK parameters of interest calculated. Data was not summarized for PK parameters if less than 3 participants had evaluable data values as pre-specified in the statistical analysis plan; hence, individual values were reported for 0.3 mg IV SAD, 1 mg IV SAD and 3 mg IV SAD cohorts. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram*hour/milliliter | Pre-dose, 2, 6, 12, 24, 48, 72, 96, 336, 672 hours post-dose (for all cohorts); 1008 hours post-dose for all cohorts except 0.3 mg IV; 1344 and 1680 hours post-dose for all cohorts except 0.3 mg IV and 1 mg IV |
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| Secondary | Part 1: SAD Cohorts: Area Under the Serum Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) for PF-07242813 | AUCinf was determined as AUClast + (Clast divided by kel), where Clast = predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel= terminal phase rate constant. | The PK parameter set consisted of all randomized participants who received at least 1 dose of study intervention and who have at least 1 of the PK parameters of interest calculated. Here, 'Overall Number of Participants Analyzed' signifies number of participants with evaluable results for this outcome measure. Data was not summarized for PK parameters if less than 3 participants had evaluable data values as pre-specified in the statistical analysis plan. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram*hour/milliliter | Pre-dose, 2, 6, 12, 24, 48, 72, 96, 336, 672 hours post-dose (for all cohorts); 1008 hours post-dose for all cohorts except 0.3 mg IV; 1344 and 1680 hours post-dose for all cohorts except 0.3 mg IV and 1 mg IV |
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| Secondary | Part 1: SAD Cohorts: Maximum Serum Concentration (Cmax) for PF-07242813 | The PK parameter set consisted of all randomized participants who received at least 1 dose of study intervention and who have at least 1 of the PK parameters of interest calculated. Data was not summarized for PK parameters if less than 3 participants had evaluable data values as pre-specified in the statistical analysis plan; hence, individual values were reported for 0.3 mg IV SAD, 1 mg IV SAD and 3 mg IV SAD cohorts. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | Pre-dose, 2, 6, 12, 24, 48, 72, 96, 336, 672 hours post-dose (for all cohorts); 1008 hours post-dose for all cohorts except 0.3 mg IV; 1344 and 1680 hours post-dose for all cohorts except 0.3 mg IV and 1 mg IV |
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| Secondary | Part 1: SAD Cohorts: Time to Reach Maximum Concentration (Tmax) for PF-07242813 | The PK parameter set consisted of all randomized participants who received at least 1 dose of study intervention and who have at least 1 of the PK parameters of interest calculated. Data was not summarized for PK parameters if less than 3 participants had evaluable data values as pre-specified in the statistical analysis plan; hence, individual values were reported for 0.3 mg IV SAD, 1 mg IV SAD and 3 mg IV SAD cohorts. | Posted | Median | Full Range | Hours | Pre-dose, 2, 6, 12, 24, 48, 72, 96, 336, 672 hours post-dose (for all cohorts); 1008 hours post-dose for all cohorts except 0.3 mg IV; 1344 and 1680 hours post-dose for all cohorts except 0.3 mg IV and 1 mg IV |
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| Secondary | Part 1: SAD Cohorts: Terminal Elimination Half Life (t1/2) for PF-07242813 | t1/2 was determined by "Loge(2)/kel", where kel was the terminal phase rate constant calculated by a linear regression of the loglinear -concentration time- curve. | The PK parameter set consisted of all randomized participants who received at least 1 dose of study intervention and who have at least 1 of the PK parameters of interest calculated. Here, 'Overall Number of Participants Analyzed' signifies number of participants with evaluable results for this outcome measure. Data was not summarized for PK parameters if less than 3 participants had evaluable data values as pre-specified in the statistical analysis plan. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | Pre-dose, 2, 6, 12, 24, 48, 72, 96, 336, 672 hours post-dose (for all cohorts); 1008 hours post-dose for all cohorts except 0.3 mg IV; 1344 and 1680 hours post-dose for all cohorts except 0.3 mg IV and 1 mg IV |
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| Secondary | Part 1: MAD Cohorts: Area Under the Serum Concentration Time Profile Over the Dosing Interval (AUCtau) for PF-07242813 | Area under the serum concentration time- profile over the dosing interval tau where tau=2 weeks (336 hours). | The PK parameter set consisted of all randomized participants who received at least 1 dose of study intervention and who have at least 1 of the PK parameters of interest calculated. Here, 'Number Analyzed' signifies number of participants evaluable for the specified timepoints. | Posted | Mean | Standard Deviation | Nanogram*hour/milliliter | Day 1,15,29(Pre-dose,2,6,12,24,48,72,96 hours post-dose) Day 15,29(168hours post-dose) Day 29(336hours post-dose) (For all cohorts); Day 1(168hours post-dose for all except 15mg and 50 mg post-dose) |
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Part 1: MAD Cohorts: Cmax for PF-07242813 | The PK parameter set consisted of all randomized participants who received at least 1 dose of study intervention and who have at least 1 of the PK parameters of interest calculated. Here, 'Number Analyzed' signifies number of participants evaluable for the specified timepoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per milliliter | Day 1,15,29(Pre-dose,2,6,12,24,48,72,96 hours post-dose) Day 15,29(168hours post-dose) Day 29(336,672,1008,1344,1680hours post-dose) (For all cohorts); Day 1(168hours post-dose for all except 15mg and 50 mg post-dose) |
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| Secondary | Part 1: MAD Cohorts: Tmax for PF-07242813 | The PK parameter set consisted of all randomized participants who received at least 1 dose of study intervention and who have at least 1 of the PK parameters of interest calculated. Here, 'Number Analyzed' signifies number of participants evaluable for the specified timepoints. | Posted | Median | Full Range | Hours | Day 1,15,29(Pre-dose,2,6,12,24,48,72,96 hours post-dose) Day 15,29(168hours post-dose) Day 29(336,672,1008,1344,1680hours post-dose) (For all cohorts); Day 1(168hours post-dose for all except 15mg and 50 mg post-dose) |
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| Secondary | Part 1: MAD Cohorts: Terminal Elimination Half Life (t1/2) for PF-07242813 | t1/2 was determined by "Loge(2) per kel", where kel was the terminal phase rate constant calculated by a linear regression of the log/linear -concentration time- curve. | The PK parameter set consisted of all randomized participants who received at least 1 dose of study intervention and who have at least 1 of the PK parameters of interest calculated. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Hours | Day 1,15,29(Pre-dose,2,6,12,24,48,72,96 hours post-dose) Day 15,29(168hours post-dose) Day 29(336,672,1008,1344,1680hours post-dose) (For all cohorts); Day 1(168hours post-dose for all except 15mg and 50 mg post-dose) |
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| Secondary | Part 2: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6 | EASI quantifies severity of AD based on severity of lesion clinical signs and percentage (%) of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema, induration/papulation, excoriation and lichenification) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin)] and lower limbs [including buttocks]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, with higher scores indicating greater severity of AD. | Modified Intention to Treat (mITT) population consisted of all randomized participants assigned to study intervention and who applied at least 1 dose of study intervention. One participant was randomized twice under different participant ID (PID) at two different sites. The participant was included in the efficacy analyses under the first PID. The participant enrolled under the second PID was included in mITT per mITT definition, but was excluded from efficacy analysis. | Posted | Least Squares Mean | 90% Confidence Interval | Percent change | Baseline, Week 6 |
|
For SAD (From start of study treatment on Day 1 to Day 71), for MAD (From start of study treatment on Day 1 to Day 99), and for AD (From start of study treatment on Day 1 to Week 16).
An AE term may be reported as both a serious and non-serious AE but are distinct events. An AE may be serious for 1 participant and non-serious for another participant, or a participant may have experienced both a serious and non-serious episode of the same event.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1: 0.3 mg IV SAD | Healthy participants were administered a single dose of 0.3 milligrams (mg) PF-07242813 as an intravenous (IV) infusion. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG001 | Part 1: 1mg IV SAD | Healthy participants were administered a single dose of 1 mg PF-07242813 as an intravenous (IV) infusion. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG002 | Part 1: 3 mg IV SAD | Healthy participants were administered a single dose of 3 mg PF-07242813 as an intravenous (IV) infusion. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG003 | Part 1: 10 mg IV SAD | Healthy participants were administered a single dose of 10 mg PF-07242813 as an intravenous (IV) infusion. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG004 | Part 1: 30 mg IV SAD | Healthy participants were administered a single dose of 30 mg PF-07242813 as an intravenous (IV) infusion. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG005 | Part 1: 100 mg IV SAD | Healthy participants were administered a single dose of 100 mg PF-07242813 as an intravenous (IV) infusion. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG006 | Part 1: 300 mg IV SAD | Healthy participants were administered a single dose of 300 mg PF-07242813 as an intravenous (IV) infusion. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG007 | Part 1: 1000 mg IV SAD | Healthy participants were administered a single dose of 1000 mg PF-07242813 as an intravenous (IV) infusion. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG008 | Part 1: 1000 mg IV SAD (Japanese Cohort) | Healthy Japanese participants were administered a single dose of 1000 mg PF-07242813 as an IV infusion. | 0 | 4 | 0 | 4 | 1 | 4 |
| EG009 | Part 1: 15 mg SC Q2W MAD | Healthy participants were administered 15 mg PF-07242813 subcutaneously every 2 weeks (Q2W) for a total of 3 doses. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG010 | Part 1: 50 mg SC Q2W MAD | Healthy participants were administered 50 mg PF-07242813 subcutaneously every 2 weeks (Q2W) for a total of 3 doses. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG011 | Part 1: 150 mg SC Q2W MAD | Healthy participants were administered 150 mg PF-07242813 subcutaneously every 2 weeks (Q2W) for a total of 3 doses. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG012 | Part 1: 300 mg SC Q2W MAD | Healthy participants were administered 300 mg PF-07242813 subcutaneously every 2 weeks (Q2W) for a total of 3 doses. | 0 | 6 | 1 | 6 | 0 | 6 |
| EG013 | Part 1: 500 mg IV Q2W MAD | Healthy participants were administered 500 mg PF-07242813 as IV infusion every 2 weeks (Q2W) for a total of 3 doses. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG014 | Part 1: Placebo SAD | Healthy participants were administered a single dose of placebo as an IV infusion. | 0 | 17 | 1 | 17 | 0 | 17 |
| EG015 | Part 1: Placebo SC MAD | Healthy participants were administered placebo every 2 weeks (Q2W) for a total of 3 doses via the SC route. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG016 | Part 1: Placebo IV MAD | Healthy participants were administered placebo every 2 weeks (Q2W) for a total of 3 doses as an IV infusion. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG017 | Part 2: 1000 mg IV AD | Participants with atopic dermatitis were administered a single dose of 1000 mg PF-07242813 administered as an IV Infusion. | 0 | 16 | 0 | 16 | 1 | 16 |
| EG018 | Part 2: Placebo IV AD | Participants with atopic dermatitis were administered a single dose of placebo as an IV infusion. | 0 | 9 | 1 | 9 | 1 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaphylactic reaction | Immune system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA v25.1 | Non-systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA v25.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 30, 2022 | Dec 4, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D003872 | Dermatitis |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| Other |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Other |
|
| 45 to 64 Years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG008 |
| Part 1: 1000 mg IV SAD (Japanese Cohort) |
Healthy Japanese participants were administered a single dose of 1000 mg PF-07242813 as an IV infusion. |
| OG009 | Part 1: Placebo SAD | Healthy participants were administered a single dose of placebo as an IV infusion. |
| TESAEs |
|
| OG002 |
| Part 1: 150 mg SC Q2W MAD |
Healthy participants were administered 150 mg PF-07242813 subcutaneously every 2 weeks (Q2W) for a total of 3 doses. |
| OG003 | Part 1: 300 mg SC Q2W MAD | Healthy participants were administered 300 mg PF-07242813 subcutaneously every 2 weeks (Q2W) for a total of 3 doses. |
| OG004 | Part 1: 500 mg IV Q2W MAD | Healthy participants were administered 500 mg PF-07242813 as IV infusion every 2 weeks (Q2W) for a total of 3 doses. |
| OG005 | Part 1: Placebo SC MAD | Healthy participants were administered placebo every 2 weeks (Q2W) for a total of 3 doses via the SC route. |
| OG006 | Part 1: Placebo IV MAD | Healthy participants were administered placebo every 2 weeks (Q2W) for a total of 3 doses as an IV infusion. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG003 |
| Part 1: 10 mg IV SAD |
Healthy participants were administered a single dose of 10 mg PF-07242813 as an intravenous (IV) infusion. |
| OG004 | Part 1: 30 mg IV SAD | Healthy participants were administered a single dose of 30 mg PF-07242813 as an intravenous (IV) infusion. |
| OG005 | Part 1: 100 mg IV SAD | Healthy participants were administered a single dose of 100 mg PF-07242813 as an intravenous (IV) infusion. |
| OG006 | Part 1: 300 mg IV SAD | Healthy participants were administered a single dose of 300 mg PF-07242813 as an intravenous (IV) infusion. |
| OG007 | Part 1: 1000 mg IV SAD | Healthy participants were administered a single dose of 1000 mg PF-07242813 as an intravenous (IV) infusion. |
| OG008 | Part 1: 1000 mg IV SAD (Japanese Cohort) | Healthy Japanese participants were administered a single dose of 1000 mg PF-07242813 as an IV infusion. |
| OG009 | Part 1: Placebo SAD | Healthy participants were administered a single dose of placebo as an IV infusion. |
|
|
| OG003 | Part 1: 300 mg SC Q2W MAD | Healthy participants were administered 300 mg PF-07242813 subcutaneously every 2 weeks (Q2W) for a total of 3 doses. |
| OG004 | Part 1: 500 mg IV Q2W MAD | Healthy participants were administered 500 mg PF-07242813 as IV infusion every 2 weeks (Q2W) for a total of 3 doses. |
| OG005 | Part 1: Placebo SC MAD | Healthy participants were administered placebo every 2 weeks (Q2W) for a total of 3 doses via the SC route. |
| OG006 | Part 1: Placebo IV MAD | Healthy participants were administered placebo every 2 weeks (Q2W) for a total of 3 doses as an IV infusion. |
|
|
|
Healthy participants were administered a single dose of 3 mg PF-07242813 as an intravenous (IV) infusion.
| OG003 | Part 1: 10 mg IV SAD | Healthy participants were administered a single dose of 10 mg PF-07242813 as an intravenous (IV) infusion. |
| OG004 | Part 1: 30 mg IV SAD | Healthy participants were administered a single dose of 30 mg PF-07242813 as an intravenous (IV) infusion. |
| OG005 | Part 1: 100 mg IV SAD | Healthy participants were administered a single dose of 100 mg PF-07242813 as an intravenous (IV) infusion. |
| OG006 | Part 1: 300 mg IV SAD | Healthy participants were administered a single dose of 300 mg PF-07242813 as an intravenous (IV) infusion. |
| OG007 | Part 1: 1000 mg IV SAD | Healthy participants were administered a single dose of 1000 mg PF-07242813 as an intravenous (IV) infusion. |
| OG008 | Part 1: 1000 mg IV SAD (Japanese Cohort) | Healthy Japanese participants were administered a single dose of 1000 mg PF-07242813 as an IV infusion. |
| OG009 | Part 1: Placebo SAD | Healthy participants were administered a single dose of placebo as an IV infusion. |
|
|
| OG003 | Part 1: 300 mg SC Q2W MAD | Healthy participants were administered 300 mg PF-07242813 subcutaneously every 2 weeks (Q2W) for a total of 3 doses. |
| OG004 | Part 1: 500 mg IV Q2W MAD | Healthy participants were administered 500 mg PF-07242813 as IV infusion every 2 weeks (Q2W) for a total of 3 doses. |
| OG005 | Part 1: Placebo SC MAD | Healthy participants were administered placebo every 2 weeks (Q2W) for a total of 3 doses via the SC route. |
| OG006 | Part 1: Placebo IV MAD | Healthy participants were administered placebo every 2 weeks (Q2W) for a total of 3 doses as an IV infusion. |
|
|
|
|
Healthy participants were administered a single dose of 10 mg PF-07242813 as an intravenous (IV) infusion. |
| OG004 | Part 1: 30 mg IV SAD | Healthy participants were administered a single dose of 30 mg PF-07242813 as an intravenous (IV) infusion. |
| OG005 | Part 1: 100 mg IV SAD | Healthy participants were administered a single dose of 100 mg PF-07242813 as an intravenous (IV) infusion. |
| OG006 | Part 1: 300 mg IV SAD | Healthy participants were administered a single dose of 300 mg PF-07242813 as an intravenous (IV) infusion. |
| OG007 | Part 1: 1000 mg IV SAD | Healthy participants were administered a single dose of 1000 mg PF-07242813 as an intravenous (IV) infusion. |
| OG008 | Part 1: 1000 mg IV SAD (Japanese Cohort) | Healthy Japanese participants were administered a single dose of 1000 mg PF-07242813 as an IV infusion. |
| OG009 | Part 1: Placebo SAD | Healthy participants were administered a single dose of placebo as an IV infusion. |
|
|
| OG003 | Part 1: 10 mg IV SAD | Healthy participants were administered a single dose of 10 mg PF-07242813 as an intravenous (IV) infusion. |
| OG004 | Part 1: 30 mg IV SAD | Healthy participants were administered a single dose of 30 mg PF-07242813 as an intravenous (IV) infusion. |
| OG005 | Part 1: 100 mg IV SAD | Healthy participants were administered a single dose of 100 mg PF-07242813 as an intravenous (IV) infusion. |
| OG006 | Part 1: 300 mg IV SAD | Healthy participants were administered a single dose of 300 mg PF-07242813 as an intravenous (IV) infusion. |
| OG007 | Part 1: 1000 mg IV SAD | Healthy participants were administered a single dose of 1000 mg PF-07242813 as an intravenous (IV) infusion. |
| OG008 | Part 1: 1000 mg IV SAD (Japanese Cohort) | Healthy Japanese participants were administered a single dose of 1000 mg PF-07242813 as an IV infusion. |
| OG009 | Part 1: Placebo SAD | Healthy participants were administered a single dose of placebo as an IV infusion. |
|
|
| OG003 |
| Part 1: 300 mg SC Q2W MAD |
Healthy participants were administered 300 mg PF-07242813 subcutaneously every 2 weeks (Q2W) for a total of 3 doses. |
| OG004 | Part 1: 500 mg IV Q2W MAD | Healthy participants were administered 500 mg PF-07242813 as IV infusion every 2 weeks (Q2W) for a total of 3 doses. |
| OG005 | Part 1: Placebo SC MAD | Healthy participants were administered placebo every 2 weeks (Q2W) for a total of 3 doses via the SC route. |
| OG006 | Part 1: Placebo IV MAD | Healthy participants were administered placebo every 2 weeks (Q2W) for a total of 3 doses as an IV infusion. |
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Healthy participants were administered a single dose of 3 mg PF-07242813 as an intravenous (IV) infusion. |
| OG003 | Part 1: 10 mg IV SAD | Healthy participants were administered a single dose of 10 mg PF-07242813 as an intravenous (IV) infusion. |
| OG004 | Part 1: 30 mg IV SAD | Healthy participants were administered a single dose of 30 mg PF-07242813 as an intravenous (IV) infusion. |
| OG005 | Part 1: 100 mg IV SAD | Healthy participants were administered a single dose of 100 mg PF-07242813 as an intravenous (IV) infusion. |
| OG006 | Part 1: 300 mg IV SAD | Healthy participants were administered a single dose of 300 mg PF-07242813 as an intravenous (IV) infusion. |
| OG007 | Part 1: 1000 mg IV SAD | Healthy participants were administered a single dose of 1000 mg PF-07242813 as an intravenous (IV) infusion. |
| OG008 | Part 1: 1000 mg IV SAD (Japanese Cohort) | Healthy Japanese participants were administered a single dose of 1000 mg PF-07242813 as an IV infusion. |
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| OG002 | Part 1: 3 mg IV SAD | Healthy participants were administered a single dose of 3 mg PF-07242813 as an intravenous (IV) infusion. |
| OG003 | Part 1: 10 mg IV SAD | Healthy participants were administered a single dose of 10 mg PF-07242813 as an intravenous (IV) infusion. |
| OG004 | Part 1: 30 mg IV SAD | Healthy participants were administered a single dose of 30 mg PF-07242813 as an intravenous (IV) infusion. |
| OG005 | Part 1: 100 mg IV SAD | Healthy participants were administered a single dose of 100 mg PF-07242813 as an intravenous (IV) infusion. |
| OG006 | Part 1: 300 mg IV SAD | Healthy participants were administered a single dose of 300 mg PF-07242813 as an intravenous (IV) infusion. |
| OG007 | Part 1: 1000 mg IV SAD | Healthy participants were administered a single dose of 1000 mg PF-07242813 as an intravenous (IV) infusion. |
| OG008 | Part 1: 1000 mg IV SAD (Japanese Cohort) | Healthy Japanese participants were administered a single dose of 1000 mg PF-07242813 as an IV infusion. |
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| OG003 | Part 1: 10 mg IV SAD | Healthy participants were administered a single dose of 10 mg PF-07242813 as an intravenous (IV) infusion. |
| OG004 | Part 1: 30 mg IV SAD | Healthy participants were administered a single dose of 30 mg PF-07242813 as an intravenous (IV) infusion. |
| OG005 | Part 1: 100 mg IV SAD | Healthy participants were administered a single dose of 100 mg PF-07242813 as an intravenous (IV) infusion. |
| OG006 | Part 1: 300 mg IV SAD | Healthy participants were administered a single dose of 300 mg PF-07242813 as an intravenous (IV) infusion. |
| OG007 | Part 1: 1000 mg IV SAD | Healthy participants were administered a single dose of 1000 mg PF-07242813 as an intravenous (IV) infusion. |
| OG008 | Part 1: 1000 mg IV SAD (Japanese Cohort) | Healthy Japanese participants were administered a single dose of 1000 mg PF-07242813 as an IV infusion. |
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| OG003 |
| Part 1: 10 mg IV SAD |
Healthy participants were administered a single dose of 10 mg PF-07242813 as an intravenous (IV) infusion. |
| OG004 | Part 1: 30 mg IV SAD | Healthy participants were administered a single dose of 30 mg PF-07242813 as an intravenous (IV) infusion. |
| OG005 | Part 1: 100 mg IV SAD | Healthy participants were administered a single dose of 100 mg PF-07242813 as an intravenous (IV) infusion. |
| OG006 | Part 1: 300 mg IV SAD | Healthy participants were administered a single dose of 300 mg PF-07242813 as an intravenous (IV) infusion. |
| OG007 | Part 1: 1000 mg IV SAD | Healthy participants were administered a single dose of 1000 mg PF-07242813 as an intravenous (IV) infusion. |
| OG008 | Part 1: 1000 mg IV SAD (Japanese Cohort) | Healthy Japanese participants were administered a single dose of 1000 mg PF-07242813 as an IV infusion. |
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Healthy participants were administered a single dose of 3 mg PF-07242813 as an intravenous (IV) infusion. |
| OG003 | Part 1: 10 mg IV SAD | Healthy participants were administered a single dose of 10 mg PF-07242813 as an intravenous (IV) infusion. |
| OG004 | Part 1: 30 mg IV SAD | Healthy participants were administered a single dose of 30 mg PF-07242813 as an intravenous (IV) infusion. |
| OG005 | Part 1: 100 mg IV SAD | Healthy participants were administered a single dose of 100 mg PF-07242813 as an intravenous (IV) infusion. |
| OG006 | Part 1: 300 mg IV SAD | Healthy participants were administered a single dose of 300 mg PF-07242813 as an intravenous (IV) infusion. |
| OG007 | Part 1: 1000 mg IV SAD | Healthy participants were administered a single dose of 1000 mg PF-07242813 as an intravenous (IV) infusion. |
| OG008 | Part 1: 1000 mg IV SAD (Japanese Cohort) | Healthy Japanese participants were administered a single dose of 1000 mg PF-07242813 as an IV infusion. |
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| OG003 | Part 1: 300 mg SC Q2W MAD | Healthy participants were administered 300 mg PF-07242813 subcutaneously every 2 weeks (Q2W) for a total of 3 doses. |
| OG004 | Part 1: 500 mg IV Q2W MAD | Healthy participants were administered 500 mg PF-07242813 as IV infusion every 2 weeks (Q2W) for a total of 3 doses. |
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Healthy participants were administered 300 mg PF-07242813 subcutaneously every 2 weeks (Q2W) for a total of 3 doses. |
| OG004 | Part 1: 500 mg IV Q2W MAD | Healthy participants were administered 500 mg PF-07242813 as IV infusion every 2 weeks (Q2W) for a total of 3 doses. |
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Healthy participants were administered 300 mg PF-07242813 subcutaneously every 2 weeks (Q2W) for a total of 3 doses. |
| OG004 | Part 1: 500 mg IV Q2W MAD | Healthy participants were administered 500 mg PF-07242813 as IV infusion every 2 weeks (Q2W) for a total of 3 doses. |
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Healthy participants were administered 150 mg PF-07242813 subcutaneously every 2 weeks (Q2W) for a total of 3 doses.
| OG003 | Part 1: 300 mg SC Q2W MAD | Healthy participants were administered 300 mg PF-07242813 subcutaneously every 2 weeks (Q2W) for a total of 3 doses. |
| OG004 | Part 1: 500 mg IV Q2W MAD | Healthy participants were administered 500 mg PF-07242813 as IV infusion every 2 weeks (Q2W) for a total of 3 doses. |
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Participants with atopic dermatitis were administered a single dose of 1000 mg PF-07242813 administered as an IV Infusion.
| OG001 | Part 2: Placebo IV AD | Participants with atopic dermatitis were administered a single dose of placebo as an IV infusion. |
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