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The purpose of this clinical trial is to learn about the safety and effects of the study medicine PF-07261271 for the potential treatment of Inflammatory Bowel Disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 active | Experimental | Dose A |
|
| Cohort 1 placebo | Placebo Comparator | Dose A |
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| Cohort 2 active | Experimental | Dose B |
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| Cohort 2 placebo | Placebo Comparator | Dose B |
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| Cohort 3 active | Experimental | Dose C |
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| Cohort 3 placebo | Placebo Comparator | Dose C |
|
| Cohort 4 active | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07261271 | Drug | IV or SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs): SAD Cohort | An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the last follow-up date, were considered as TEAEs. AEs included all SAEs and Non-SAEs. | From start of study intervention (Day 1) up to end of study, approximately up to 15 months |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs): MD Cohort | An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the last follow-up date, were considered as TEAEs. AEs included all SAEs and Non-SAEs. | From start of study intervention (Day 1) up to end of study, approximately of 15.5 months |
| Number of Participants With Serious Adverse Events (SAEs): SAD Cohort | An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAEs were defined as any untoward medical occurrence that, at any dose, met one or more of the criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or other medically significant event. | From start of study intervention (Day 1) up to end of study, approximately up to 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration Versus Time Curve From Time Zero to the Last Quantifiable Time Point (AUClast) of PF-07261271: SAD Cohort | AUClast was determined using Linear Log trapezoidal method. | Predose and 0, 2, 4, 8, 12, 24, 48, 72, 192, 360, 768, 1104, 1464, 2184, 4344, 5064, 5784, 6504, 7224, 7944, 8664, 10824 hours post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orange County Research Center | Lake Forest | California | 92630 | United States | ||
| Orange County Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42235928 | Derived | Neelakantan S, Banfield C, Hung K, Sapone A, Pradhan V, Zhao Y, Parsons-Rich D, Lee G, Johnson BG, Peeva E, Vincent MS, Clerin VM. A phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-07261271 in healthy participants. Br J Clin Pharmacol. 2026 Jun 3. doi: 10.1002/bcp.70602. Online ahead of print. |
| 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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In this study, dose have been reported from dose levels 1 to 4, wherein dose level 1 is the lowest dose and dose level 4 is the highest dose received by the study participants.
A total of 35 participants (27 participants assigned to single ascending dose [SAD] cohorts and 8 participants assigned in the multiple doses [MD] cohorts) were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | SAD: Placebo | Healthy participants who were randomized to receive placebo matched to PF-07261271 as single intravenous (IV) dose on Day 1. |
| FG001 | SAD: PF-07261271 Dose Level 1 | Healthy participants who were randomized to receive PF-07261271 Dose Level 1 as single IV dose on Day 1. |
| FG002 | SAD: PF-07261271 Dose Level 2 | Healthy participants who were randomized to receive PF-07261271 Dose Level 2 as single IV dose on Day 1. |
| FG003 | SAD: PF-07261271 Dose Level 3 | Healthy participants who were randomized to receive PF-07261271 Dose Level 3 as single IV dose on Day 1. |
| FG004 | SAD: PF-07261271 Dose Level 4 | Healthy participants who were randomized to receive PF-07261271 Dose Level 4 as single IV dose on Day 1. |
| FG005 | SAD: Placebo (Japanese Participants) | Healthy Japanese participants who were randomized to receive placebo matched to PF-07261271 as single dose on Day 1. |
| FG006 | SAD: PF-07261271 Dose Level 4 (Japanese Participants) | Healthy Japanese participants who were randomized to receive PF-07261271 Dose Level 4 as single IV dose on Day 1. |
| FG007 | MD: Placebo | Healthy participants who were randomized to receive placebo matched to PF-07261271 as repeated subcutaneous (SC) doses on Day 1 and Day 29. |
| FG008 | MD: PF-07261271 Dose Level 3 | Healthy participants who were randomized to receive PF-07261271 Dose Level 3 repeated SC doses on Day 1 and Day 29. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | SAD: Placebo | Healthy participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1. |
| BG001 | SAD: PF-07261271 Dose Level 1 | Healthy participants who were randomized to receive PF-07261271 Dose Level 1 as single IV dose on Day 1. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs): SAD Cohort | An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the last follow-up date, were considered as TEAEs. AEs included all SAEs and Non-SAEs. | Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From start of study intervention (Day 1) up to end of study, approximately up to 15 months |
|
SAD Cohort: From start of study intervention (Day 1) up to approximately 15 months and MD Cohort: From start of study intervention (Day 1) up to approximately 15.5 months
Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SAD: Placebo | Healthy participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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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 | Oct 19, 2023 | Feb 27, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 18, 2024 | Feb 27, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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Dose D |
|
| Cohort 4 placebo | Placebo Comparator | Dose D |
|
| Cohort 5 active | Experimental | Dose E |
|
| Cohort 5 placebo | Placebo Comparator | Dose E |
|
| Cohort 6 active | Experimental | Dose F |
|
| Cohort 6 placebo | Placebo Comparator | Dose F |
|
| Cohort 7 active | Experimental | Dose G |
|
| Cohort 7 placebo | Placebo Comparator | Dose G |
|
| Cohort 8 active | Experimental | Dose H |
|
| Cohort 8 placebo | Placebo Comparator | Dose H |
|
| Placebo | Drug | IV or SC |
|
| Number of Participants With Serious Adverse Events (SAEs): MD Cohort | An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAEs were defined as any untoward medical occurrence that, at any dose, met one or more of the criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or other medically significant event. | From start of study intervention (Day 1) up to end of study, approximately of 15.5 months |
| Number of Participants With Clinically Significant Changes in Vital Signs Abnormalities: SAD Cohort | Criteria for abnormal values of vital signs: systolic blood pressure (millimeters of mercury [mmHg]) value less than (<) 90 mmHg, change greater than or equal to (>=) 30 mmHg increase, change >= 30 mmHg decrease; diastolic blood pressure (mmHg), value <50 mmHg, change >=20 mmHg increase, change >=20 mmHg decrease; pulse rate (beats per minute [bpm]) value <40bpm, value greater than (>) 120bpm. Clinical significance was determined based on investigator's discretion. | From start of study intervention (Day 1) up to end of study, approximately up to 15 months |
| Number of Participants With Clinically Significant Changes in Vital Signs Abnormalities: MD Cohort | Criteria for abnormal values of vital signs: systolic blood pressure (mmHg) value < 90 mmHg, change >= 30 mmHg increase, change >= 30 mmHg decrease; diastolic blood pressure (mmHg), value <50 mmHg, change >=20 mmHg increase, change >=20 mmHg decrease; pulse rate (bpm) value < 40bpm, value > 120bpm. Clinical significance was determined based on investigator's discretion. | From start of study intervention (Day 1) up to end of study, approximately of 15.5 months |
| Number of Participants With Clinically Significant Changes in Laboratory Abnormalities: SAD Cohort | Criteria:Hematology(Activated partial thromboplastin time>1.1*upper limit of normal(ULN); Basophils &eosinophils>1.2*ULN; erythrocytes,hematocrit,hemoglobin,lymphocytes,neutrophils <0.8*lower limit of normal(LLN); leukocytes <0.6*LLN, >1.5*ULN; monocytes >1.2*ULN; platelets <0.5*LLN; prothrombin international randomized ratio &prothrombin Time >1.1*ULN), clinical chemistry (alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase >3.0*ULN; albumin, protein <0.8*LLN, >1.2*ULN; bicarbonate, calcium, chloride, potassium <0.9*LLN,>1.1*ULN; bilirubin >1.5*ULN; creatinine >1.3*ULN; glucose, Glucose-FASTING <0.6*LLN,>1.5*ULN; Sodium <0.95*LLN,>1.05*ULN; Urate: >1.2*ULN;Urea Nitrogen: >1.3*ULN),urinalysis(Bacteria > 20;epithelial cells >=6;granular, hyaline, RBC&WBC casts >1;ketones,leukocyte esterase, nitrite, urine glucose, urine hemoglobin, urine protein>=1,urine erythrocytes,leukocytes >=20;pH(scalar)<4.5,>8.Clinical significance determined on investigator's discretion. | From start of study intervention (Day 1) up to end of study, approximately up to 15 months |
| Number of Participants With Clinically Significant Changes in Laboratory Abnormalities: MD Cohort | Criteria:Hematology(Activated partial thromboplastin time>1.1*upper limit of normal(ULN); Basophils &eosinophils>1.2*ULN; erythrocytes,hematocrit,hemoglobin,lymphocytes,neutrophils <0.8*lower limit of normal(LLN); leukocytes <0.6*LLN, >1.5*ULN; monocytes >1.2*ULN; platelets <0.5*LLN; prothrombin international randomized ratio &prothrombin Time >1.1*ULN), clinical chemistry (alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase >3.0*ULN; albumin, protein <0.8*LLN, >1.2*ULN; bicarbonate, calcium, chloride, potassium <0.9*LLN,>1.1*ULN; bilirubin >1.5*ULN; creatinine >1.3*ULN; glucose, Glucose-FASTING <0.6*LLN,>1.5*ULN; Sodium <0.95*LLN,>1.05*ULN; Urate: >1.2*ULN;Urea Nitrogen: >1.3*ULN),urinalysis(Bacteria > 20;epithelial cells >=6;granular, hyaline, RBC&WBC casts >1;ketones,leukocyte esterase, nitrite, urine glucose, urine hemoglobin, urine protein>=1,urine erythrocytes,leukocytes >=20;pH(scalar)<4.5,>8.Clinical significance determined on investigator's discretion. | From start of study intervention (Day 1) up to end of study, approximately of 15.5 months |
| Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Abnormalities: SAD Cohort | Criteria for abnormal values of ECG parameters: pulse rate (PR) interval greater than or equal to (>=)300 milliseconds (msec); PR interval change >=25 percent (%) or >=50 %, QRS interval >=140 msec and QRS interval change: >=50%. QT interval using Fridericia's correction (QTcF) range from 450 msec to less than (<)480 msec, less than (<) 480 msec to maximum less than or equal to (<=)500 msec, >500 msec, <=30 to <60 msec and >=60 msec. Only rows which included at least 1 participant with abnormality are reported in this outcome measure. Clinical significance was determined based on investigator's discretion. | From start of study intervention (Day 1) up to end of study, approximately up to 15 months |
| Number of Participants With Clinically Significant Changes in ECG Abnormalities: MD Cohort | Criteria for abnormal values of ECG parameters: pulse rate (PR) interval greater than or equal to (>=)300 milliseconds (msec); PR interval change >=25 percent (%) or >=50 %, QRS interval >=140 msec and QRS interval change: >=50%. QT interval using Fridericia's correction (QTcF) range from 450 msec to less than (<)480 msec, less than (<) 480 msec to maximum less than or equal to (<=)500 msec, >500 msec, <=30 to <60 msec and >=60 msec. Only rows which included at least 1 participant with abnormality are reported in this outcome measure. Clinical significance was determined based on investigator's discretion. | From start of study intervention (Day 1) up to end of study, approximately of 15.5 months |
| Area Under the Serum Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-07261271: SAD Cohort |
AUCinf was determined as AUClast + (Clast*/kel), where Clast* is the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. |
| Predose and 0, 2, 4, 8, 12, 24, 48, 72, 192, 360, 768, 1104, 1464, 2184, 4344, 5064, 5784, 6504, 7224, 7944, 8664, 10824 hours post dose |
| Maximum Plasma Concentration (Cmax) of PF-07261271: SAD Cohort | Cmax was defined as maximum serum concentration. | Predose and 0, 2, 4, 8, 12, 24, 48, 72, 192, 360, 768, 1104, 1464, 2184, 4344, 5064, 5784, 6504, 7224, 7944, 8664, 10824 hours post dose |
| Time to Maximum Plasma Concentration (Tmax) of PF-07261271: SAD Cohort | Tmax was defined as time for Cmax. | Predose and 0, 2, 4, 8, 12, 24, 48, 72, 192, 360, 768, 1104, 1464, 2184, 4344, 5064, 5784, 6504, 7224, 7944, 8664, 10824 hours post dose |
| Terminal Elimination Half-life (t1/2) of PF-07261271: SAD Cohort | t1/2 was determined using Loge (2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear -concentration time- curve. | Predose and 0, 2, 4, 8, 12, 24, 48, 72, 192, 360, 768, 1104, 1464, 2184, 4344, 5064, 5784, 6504, 7224, 7944, 8664, 10824 hours post dose |
| Area Under the Concentration Time Profile From Time Zero to Time Tau (τ), the Dosing Interval (AUCtau) of PF-07261271: MD Cohort | AUCtau was defined as area under the concentration time profile from time zero to time tau (τ), the dosing interval, where tau=672 hours for every 4-week dosing. AUCtau was determined by Linear Log trapezoidal method. | Predose and 0, 2, 4, 8, 12, 48, 96, 192, 360, 720, 744, 1224, 1584, 1944, 2664, 4104, 4824, 5544, 6264, 6984, 7704, 8424, 9144 and 11304 hours post-dose on Day 1 and 29 |
| Cmax of PF-07261271: MD Cohort | Cmax was defined as maximum serum concentration. | Predose and 0, 2, 4, 8, 12, 48, 96, 192, 360, 720, 744, 1224, 1584, 1944, 2664, 4104, 4824, 5544, 6264, 6984, 7704, 8424, 9144 and 11304 hours post-dose on Day 1 and 29 |
| Tmax of PF-07261271: MD Cohort | Tmax was defined as time for Cmax. | Predose and 0, 2, 4, 8, 12, 48, 96, 192, 360, 720, 744, 1224, 1584, 1944, 2664, 4104, 4824, 5544, 6264, 6984, 7704, 8424, 9144 and 11304 hours post-dose on Day 1 and 29 |
| Terminal Elimination Half-life (t1/2) of PF-07261271: MD Cohort | t1/2 was determined using Loge (2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear -concentration time- curve. | Predose and 0, 2, 4, 8, 12, 48, 96, 192, 360, 720, 744, 1224, 1584, 1944, 2664, 4104, 4824, 5544, 6264, 6984, 7704, 8424, 9144 and 11304 hours post-dose on Day 1 and 29 |
| Number of Participants With Anti-drug Antibodies (ADA) Against PF-07261271: SAD Cohort | ADA positive was defined as ADA titer >= 100; ADA negative defined as ADA titer < 100. Baseline was defined as the last pre-dose measurement | Baseline up to 15 months |
| Number of Participants With ADA Against PF-07261271: MD Cohort | ADA positive defined as ADA titer >= 100; ADA negative defined as ADA titer < 100. Baseline was defined as the last pre-dose measurement. | Baseline up to 15.5 months |
| Number of Participants With Neutralizing Antibodies (NAb) Against PF-07261271: SAD Cohort | NAb was determined by electrochemiluminescent (ECL) competitive ligand binding assay using the Meso Scale Discovery (MSD) platform. | Baseline up to 15 months |
| Number of Participants With NAb Against PF-07261271: MD Cohort | NAb was determined by electrochemiluminescent (ECL) competitive ligand binding assay using the Meso Scale Discovery (MSD) platform. | Baseline up to 15.5 months |
| Tustin |
| California |
| 92780 |
| United States |
| Clinilabs | Eatontown | New Jersey | 07724 | United States |
| ICON | Salt Lake City | Utah | 84124 | United States |
| BG002 | SAD: PF-07261271 Dose Level 2 | Healthy participants who were randomized to receive PF-07261271 Dose level 2 as single IV dose on Day 1. |
| BG003 | SAD: PF-07261271 Dose Level 3 | Healthy participants who were randomized to receive PF-07261271 Dose level 3 as single IV dose on Day 1. |
| BG004 | SAD: PF-07261271 Dose Level 4 | Healthy participants who were randomized to receive PF-07261271 Dose level 4 as single IV dose on Day 1. |
| BG005 | SAD: Placebo (Japanese Participants) | Healthy Japanese participants who were randomized to receive placebo matched to PF-07261271 as single dose on Day 1. |
| BG006 | SAD: PF-07261271 Dose Level 4 (Japanese Participants) | Healthy Japanese participants who were randomized to receive PF-07261271 Dose level 4 as single IV dose on Day 1. |
| BG007 | MD: Placebo | Healthy participants who were randomized to receive placebo matched to PF-07261271 as repeated subcutaneous (SC) doses on Day 1 and Day 29. |
| BG008 | MD: PF-07261271 Dose Level 3 | Healthy participants who were randomized to receive PF-07261271 Dose level 3 repeated escalating SC doses on Day 1 and Day 29. |
| BG009 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Healthy participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1.
| OG001 | SAD: PF-07261271 Dose Level 1 | Healthy participants who were randomized to receive PF-07261271 dose level 1 as single IV dose on Day 1. |
| OG002 | SAD: PF-07261271 Dose Level 2 | Healthy participants who were randomized to receive PF-07261271 dose level 2 as single IV dose on Day 1. |
| OG003 | SAD: PF-07261271 Dose Level 3 | Healthy participants who were randomized to receive PF-07261271 dose level 3 as single IV dose on Day 1. |
| OG004 | SAD: PF-07261271 Dose Level 4 | Healthy participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1. |
| OG005 | SAD: Placebo (Japanese Participants) | Healthy Japanese participants who were randomized to receive placebo matched to PF-07261271 as single IV dose on Day 1. |
| OG006 | SAD: PF-07261271 Dose Level 4 (Japanese Participants) | Healthy Japanese participants who were randomized to receive PF-07261271 dose level 4 as single IV dose on Day 1. |
|
|
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs): MD Cohort | An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the last follow-up date, were considered as TEAEs. AEs included all SAEs and Non-SAEs. | Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From start of study intervention (Day 1) up to end of study, approximately of 15.5 months |
|
|
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| Primary | Number of Participants With Serious Adverse Events (SAEs): SAD Cohort | An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAEs were defined as any untoward medical occurrence that, at any dose, met one or more of the criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or other medically significant event. | Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From start of study intervention (Day 1) up to end of study, approximately up to 15 months |
|
|
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| Primary | Number of Participants With Serious Adverse Events (SAEs): MD Cohort | An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAEs were defined as any untoward medical occurrence that, at any dose, met one or more of the criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or other medically significant event. | Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From start of study intervention (Day 1) up to end of study, approximately of 15.5 months |
|
|
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| Primary | Number of Participants With Clinically Significant Changes in Vital Signs Abnormalities: SAD Cohort | Criteria for abnormal values of vital signs: systolic blood pressure (millimeters of mercury [mmHg]) value less than (<) 90 mmHg, change greater than or equal to (>=) 30 mmHg increase, change >= 30 mmHg decrease; diastolic blood pressure (mmHg), value <50 mmHg, change >=20 mmHg increase, change >=20 mmHg decrease; pulse rate (beats per minute [bpm]) value <40bpm, value greater than (>) 120bpm. Clinical significance was determined based on investigator's discretion. | Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From start of study intervention (Day 1) up to end of study, approximately up to 15 months |
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| Primary | Number of Participants With Clinically Significant Changes in Vital Signs Abnormalities: MD Cohort | Criteria for abnormal values of vital signs: systolic blood pressure (mmHg) value < 90 mmHg, change >= 30 mmHg increase, change >= 30 mmHg decrease; diastolic blood pressure (mmHg), value <50 mmHg, change >=20 mmHg increase, change >=20 mmHg decrease; pulse rate (bpm) value < 40bpm, value > 120bpm. Clinical significance was determined based on investigator's discretion. | Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From start of study intervention (Day 1) up to end of study, approximately of 15.5 months |
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| Primary | Number of Participants With Clinically Significant Changes in Laboratory Abnormalities: SAD Cohort | Criteria:Hematology(Activated partial thromboplastin time>1.1*upper limit of normal(ULN); Basophils &eosinophils>1.2*ULN; erythrocytes,hematocrit,hemoglobin,lymphocytes,neutrophils <0.8*lower limit of normal(LLN); leukocytes <0.6*LLN, >1.5*ULN; monocytes >1.2*ULN; platelets <0.5*LLN; prothrombin international randomized ratio &prothrombin Time >1.1*ULN), clinical chemistry (alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase >3.0*ULN; albumin, protein <0.8*LLN, >1.2*ULN; bicarbonate, calcium, chloride, potassium <0.9*LLN,>1.1*ULN; bilirubin >1.5*ULN; creatinine >1.3*ULN; glucose, Glucose-FASTING <0.6*LLN,>1.5*ULN; Sodium <0.95*LLN,>1.05*ULN; Urate: >1.2*ULN;Urea Nitrogen: >1.3*ULN),urinalysis(Bacteria > 20;epithelial cells >=6;granular, hyaline, RBC&WBC casts >1;ketones,leukocyte esterase, nitrite, urine glucose, urine hemoglobin, urine protein>=1,urine erythrocytes,leukocytes >=20;pH(scalar)<4.5,>8.Clinical significance determined on investigator's discretion. | Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From start of study intervention (Day 1) up to end of study, approximately up to 15 months |
|
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| Primary | Number of Participants With Clinically Significant Changes in Laboratory Abnormalities: MD Cohort | Criteria:Hematology(Activated partial thromboplastin time>1.1*upper limit of normal(ULN); Basophils &eosinophils>1.2*ULN; erythrocytes,hematocrit,hemoglobin,lymphocytes,neutrophils <0.8*lower limit of normal(LLN); leukocytes <0.6*LLN, >1.5*ULN; monocytes >1.2*ULN; platelets <0.5*LLN; prothrombin international randomized ratio &prothrombin Time >1.1*ULN), clinical chemistry (alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase >3.0*ULN; albumin, protein <0.8*LLN, >1.2*ULN; bicarbonate, calcium, chloride, potassium <0.9*LLN,>1.1*ULN; bilirubin >1.5*ULN; creatinine >1.3*ULN; glucose, Glucose-FASTING <0.6*LLN,>1.5*ULN; Sodium <0.95*LLN,>1.05*ULN; Urate: >1.2*ULN;Urea Nitrogen: >1.3*ULN),urinalysis(Bacteria > 20;epithelial cells >=6;granular, hyaline, RBC&WBC casts >1;ketones,leukocyte esterase, nitrite, urine glucose, urine hemoglobin, urine protein>=1,urine erythrocytes,leukocytes >=20;pH(scalar)<4.5,>8.Clinical significance determined on investigator's discretion. | Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From start of study intervention (Day 1) up to end of study, approximately of 15.5 months |
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| Primary | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Abnormalities: SAD Cohort | Criteria for abnormal values of ECG parameters: pulse rate (PR) interval greater than or equal to (>=)300 milliseconds (msec); PR interval change >=25 percent (%) or >=50 %, QRS interval >=140 msec and QRS interval change: >=50%. QT interval using Fridericia's correction (QTcF) range from 450 msec to less than (<)480 msec, less than (<) 480 msec to maximum less than or equal to (<=)500 msec, >500 msec, <=30 to <60 msec and >=60 msec. Only rows which included at least 1 participant with abnormality are reported in this outcome measure. Clinical significance was determined based on investigator's discretion. | Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From start of study intervention (Day 1) up to end of study, approximately up to 15 months |
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| Primary | Number of Participants With Clinically Significant Changes in ECG Abnormalities: MD Cohort | Criteria for abnormal values of ECG parameters: pulse rate (PR) interval greater than or equal to (>=)300 milliseconds (msec); PR interval change >=25 percent (%) or >=50 %, QRS interval >=140 msec and QRS interval change: >=50%. QT interval using Fridericia's correction (QTcF) range from 450 msec to less than (<)480 msec, less than (<) 480 msec to maximum less than or equal to (<=)500 msec, >500 msec, <=30 to <60 msec and >=60 msec. Only rows which included at least 1 participant with abnormality are reported in this outcome measure. Clinical significance was determined based on investigator's discretion. | Safety analysis set included all participants randomly assigned to study intervention who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From start of study intervention (Day 1) up to end of study, approximately of 15.5 months |
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| Secondary | Area Under the Concentration Versus Time Curve From Time Zero to the Last Quantifiable Time Point (AUClast) of PF-07261271: SAD Cohort | AUClast was determined using Linear Log trapezoidal method. | Pharmacokinetic (PK) parameter analysis population included all randomized participants who received at least 1 dose of PF-07261271 and who had at least 1 of the PK parameters of interest calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms*hour per milliliter | Predose and 0, 2, 4, 8, 12, 24, 48, 72, 192, 360, 768, 1104, 1464, 2184, 4344, 5064, 5784, 6504, 7224, 7944, 8664, 10824 hours post dose |
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| Secondary | Area Under the Serum Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-07261271: SAD Cohort | AUCinf was determined as AUClast + (Clast*/kel), where Clast* is the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. | PK parameter analysis population included all randomized participants who received at least 1 dose of PF-07261271 and who had at least 1 of the PK parameters of interest calculated. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms*hour per milliliter | Predose and 0, 2, 4, 8, 12, 24, 48, 72, 192, 360, 768, 1104, 1464, 2184, 4344, 5064, 5784, 6504, 7224, 7944, 8664, 10824 hours post dose |
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| Secondary | Maximum Plasma Concentration (Cmax) of PF-07261271: SAD Cohort | Cmax was defined as maximum serum concentration. | PK parameter analysis population included all randomized participants who received at least 1 dose of PF-07261271 and who had at least 1 of the PK parameters of interest calculated. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | Predose and 0, 2, 4, 8, 12, 24, 48, 72, 192, 360, 768, 1104, 1464, 2184, 4344, 5064, 5784, 6504, 7224, 7944, 8664, 10824 hours post dose |
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| Secondary | Time to Maximum Plasma Concentration (Tmax) of PF-07261271: SAD Cohort | Tmax was defined as time for Cmax. | PK parameter analysis population included all randomized participants who received at least 1 dose of PF-07261271 and who had at least 1 of the PK parameters of interest calculated. | Posted | Median | Full Range | Hours | Predose and 0, 2, 4, 8, 12, 24, 48, 72, 192, 360, 768, 1104, 1464, 2184, 4344, 5064, 5784, 6504, 7224, 7944, 8664, 10824 hours post dose |
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| Secondary | Terminal Elimination Half-life (t1/2) of PF-07261271: SAD Cohort | t1/2 was determined using Loge (2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear -concentration time- curve. | PK parameter analysis population included all randomized participants who received at least 1 dose of PF-07261271 and who had at least 1 of the PK parameters of interest calculated. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Hours | Predose and 0, 2, 4, 8, 12, 24, 48, 72, 192, 360, 768, 1104, 1464, 2184, 4344, 5064, 5784, 6504, 7224, 7944, 8664, 10824 hours post dose |
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| Secondary | Area Under the Concentration Time Profile From Time Zero to Time Tau (τ), the Dosing Interval (AUCtau) of PF-07261271: MD Cohort | AUCtau was defined as area under the concentration time profile from time zero to time tau (τ), the dosing interval, where tau=672 hours for every 4-week dosing. AUCtau was determined by Linear Log trapezoidal method. | PK parameter analysis population included all randomized participants who received at least 1 dose of PF-07261271 and who had at least 1 of the PK parameters of interest calculated. Here, 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms*hour per milliliter | Predose and 0, 2, 4, 8, 12, 48, 96, 192, 360, 720, 744, 1224, 1584, 1944, 2664, 4104, 4824, 5544, 6264, 6984, 7704, 8424, 9144 and 11304 hours post-dose on Day 1 and 29 |
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| Secondary | Cmax of PF-07261271: MD Cohort | Cmax was defined as maximum serum concentration. | PK parameter analysis population included all randomized participants who received at least 1 dose of PF-07261271 and who had at least 1 of the PK parameters of interest calculated. Here, 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms*hour per milliliter | Predose and 0, 2, 4, 8, 12, 48, 96, 192, 360, 720, 744, 1224, 1584, 1944, 2664, 4104, 4824, 5544, 6264, 6984, 7704, 8424, 9144 and 11304 hours post-dose on Day 1 and 29 |
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| Secondary | Tmax of PF-07261271: MD Cohort | Tmax was defined as time for Cmax. | PK parameter analysis population included all randomized participants who received at least 1 dose of PF-07261271 and who had at least 1 of the PK parameters of interest calculated. Here, 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Median | Full Range | Hours | Predose and 0, 2, 4, 8, 12, 48, 96, 192, 360, 720, 744, 1224, 1584, 1944, 2664, 4104, 4824, 5544, 6264, 6984, 7704, 8424, 9144 and 11304 hours post-dose on Day 1 and 29 |
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| Secondary | Terminal Elimination Half-life (t1/2) of PF-07261271: MD Cohort | t1/2 was determined using Loge (2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear -concentration time- curve. | PK parameter analysis population included all randomized participants who received at least 1 dose of PF-07261271 and who had at least 1 of the PK parameters of interest calculated. | Posted | Mean | Standard Deviation | Hours | Predose and 0, 2, 4, 8, 12, 48, 96, 192, 360, 720, 744, 1224, 1584, 1944, 2664, 4104, 4824, 5544, 6264, 6984, 7704, 8424, 9144 and 11304 hours post-dose on Day 1 and 29 |
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| Secondary | Number of Participants With Anti-drug Antibodies (ADA) Against PF-07261271: SAD Cohort | ADA positive was defined as ADA titer >= 100; ADA negative defined as ADA titer < 100. Baseline was defined as the last pre-dose measurement | Immunogenicity data analysis was performed on the safety analysis set. | Posted | Count of Participants | Participants | Baseline up to 15 months |
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| Secondary | Number of Participants With ADA Against PF-07261271: MD Cohort | ADA positive defined as ADA titer >= 100; ADA negative defined as ADA titer < 100. Baseline was defined as the last pre-dose measurement. | Immunogenicity data analysis was performed on the safety analysis set. | Posted | Count of Participants | Participants | Baseline up to 15.5 months |
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| Secondary | Number of Participants With Neutralizing Antibodies (NAb) Against PF-07261271: SAD Cohort | NAb was determined by electrochemiluminescent (ECL) competitive ligand binding assay using the Meso Scale Discovery (MSD) platform. | Immunogenicity data analysis was performed on the safety analysis set. | Posted | Count of Participants | Participants | Baseline up to 15 months |
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| Secondary | Number of Participants With NAb Against PF-07261271: MD Cohort | NAb was determined by electrochemiluminescent (ECL) competitive ligand binding assay using the Meso Scale Discovery (MSD) platform. | Immunogenicity data analysis was performed on the safety analysis set. | Posted | Count of Participants | Participants | Baseline up to 15.5 months |
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| 0 |
| 8 |
| 0 |
| 8 |
| 4 |
| 8 |
| EG001 | SAD: PF-07261271 Dose Level 1 | Healthy participants who were randomized to receive PF-07261271 dose level 1 as single IV dose on Day 1. | 0 | 2 | 0 | 2 | 1 | 2 |
| EG002 | SAD: PF-07261271 Dose Level 2 | Healthy participants who were randomized to receive PF-07261271 Dose level 2 as single IV dose on Day 1. | 0 | 2 | 0 | 2 | 1 | 2 |
| EG003 | SAD: PF-07261271 Dose Level 3 | Healthy participants who were randomized to receive PF-07261271 Dose level 3 as single IV dose on Day 1. | 0 | 4 | 0 | 4 | 3 | 4 |
| EG004 | SAD: PF-07261271 Dose Level 4 | Healthy participants who were randomized to receive PF-07261271 Dose level 4 as single IV dose on Day 1. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG005 | SAD: Placebo (Japanese Participants) | Healthy Japanese participants who were randomized to receive placebo matched to PF-07261271 as single dose on Day 1. | 0 | 1 | 0 | 1 | 0 | 1 |
| EG006 | SAD: PF-07261271 Dose Level 4 (Japanese Participants) | Healthy Japanese participants who were randomized to receive PF-07261271 Dose level 4 as single IV dose on Day 1. | 0 | 4 | 0 | 4 | 1 | 4 |
| EG007 | MD: Placebo | Healthy participants who were randomized to receive placebo matched to PF-07261271 as repeated SC dose on Day 1 and Day 29. | 0 | 2 | 0 | 2 | 2 | 2 |
| EG008 | MD: PF-07261271 Dose Level 3 | Healthy participants who were randomized to receive PF-07261271 300 mg repeated escalating SC doses on Day 1 and Day 29. | 0 | 6 | 0 | 6 | 5 | 6 |
| Ventricular extrasystoles | Cardiac disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Chills | General disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Injection site pain | General disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Injection site reaction | General disorders | MedDRA v26.1 | Non-systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
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| Fungal infection | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA v26.1 | Non-systematic Assessment |
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| Fibula fracture | Injury, poisoning and procedural complications | MedDRA v26.1 | Non-systematic Assessment |
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| Foot fracture | Injury, poisoning and procedural complications | MedDRA v26.1 | Non-systematic Assessment |
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| Muscle rupture | Injury, poisoning and procedural complications | MedDRA v26.1 | Non-systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MedDRA v26.1 | Non-systematic Assessment |
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| Hepatic enzyme increased | Investigations | MedDRA v26.1 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA v26.1 | Non-systematic Assessment |
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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.
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