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Completed

NCT Number: NCT05536440

A Study to Learn About Study Medicine Called PF-07261271 in Healthy People

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Orange County Research Center, Lake Forest, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy individuals as determined by medical evaluation
  • Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

Exclusion criteria

  • Clinically significant medical conditions
  • History of HIV infection, hepatitis B, or hepatitis C
  • BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic)
  • Clinically relevant ECG abnormalities
  • Previous study drug administration within 30 days or 5 half-lives of first planned dose
  • History of drug/alcohol abuse or >20 cigarettes/day

Treatment and study plan

PF-07261271

Drug

IV or SC

Placebo

Drug

IV or SC

Primary outcomes

  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs): SAD Cohort

    Time frame: From start of study intervention (Day 1) up to end of study, approximately up to 15 months

    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.

  2. Number of Participants With Treatment Emergent Adverse Events (TEAEs): MD Cohort

    Time frame: From start of study intervention (Day 1) up to end of study, approximately of 15.5 months

    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.

  3. Number of Participants With Serious Adverse Events (SAEs): SAD Cohort

    Time frame: From start of study intervention (Day 1) up to end of study, approximately up to 15 months

    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.

  4. Number of Participants With Serious Adverse Events (SAEs): MD Cohort

    Time frame: From start of study intervention (Day 1) up to end of study, approximately of 15.5 months

    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.

  5. Number of Participants With Clinically Significant Changes in Vital Signs Abnormalities: SAD Cohort

    Time frame: From start of study intervention (Day 1) up to end of study, approximately up to 15 months

    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.

  6. Number of Participants With Clinically Significant Changes in Vital Signs Abnormalities: MD Cohort

    Time frame: From start of study intervention (Day 1) up to end of study, approximately of 15.5 months

    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.

  7. Number of Participants With Clinically Significant Changes in Laboratory Abnormalities: SAD Cohort

    Time frame: From start of study intervention (Day 1) up to end of study, approximately up to 15 months

    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.

  8. Number of Participants With Clinically Significant Changes in Laboratory Abnormalities: MD Cohort

    Time frame: From start of study intervention (Day 1) up to end of study, approximately of 15.5 months

    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.

  9. Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Abnormalities: SAD Cohort

    Time frame: From start of study intervention (Day 1) up to end of study, approximately up to 15 months

    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.

  10. Number of Participants With Clinically Significant Changes in ECG Abnormalities: MD Cohort

    Time frame: From start of study intervention (Day 1) up to end of study, approximately of 15.5 months

    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.

Secondary outcomes

  1. Area Under the Concentration Versus Time Curve From Time Zero to the Last Quantifiable Time Point (AUClast) of PF-07261271: SAD Cohort

    Time frame: 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

    AUClast was determined using Linear Log trapezoidal method.

  2. Area Under the Serum Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-07261271: SAD Cohort

    Time frame: 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

    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.

  3. Maximum Plasma Concentration (Cmax) of PF-07261271: SAD Cohort

    Time frame: 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

    Cmax was defined as maximum serum concentration.

  4. Time to Maximum Plasma Concentration (Tmax) of PF-07261271: SAD Cohort

    Time frame: 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

    Tmax was defined as time for Cmax.

  5. Terminal Elimination Half-life (t1/2) of PF-07261271: SAD Cohort

    Time frame: 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

    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.

  6. Area Under the Concentration Time Profile From Time Zero to Time Tau (τ), the Dosing Interval (AUCtau) of PF-07261271: MD Cohort

    Time frame: 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

    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.

  7. Cmax of PF-07261271: MD Cohort

    Time frame: 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 was defined as maximum serum concentration.

  8. Tmax of PF-07261271: MD Cohort

    Time frame: 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 was defined as time for Cmax.

  9. Terminal Elimination Half-life (t1/2) of PF-07261271: MD Cohort

    Time frame: 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

    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.

  10. Number of Participants With Anti-drug Antibodies (ADA) Against PF-07261271: SAD Cohort

    Time frame: Baseline up to 15 months

    ADA positive was defined as ADA titer >= 100; ADA negative defined as ADA titer < 100. Baseline was defined as the last pre-dose measurement

  11. Number of Participants With ADA Against PF-07261271: MD Cohort

    Time frame: Baseline up to 15.5 months

    ADA positive defined as ADA titer >= 100; ADA negative defined as ADA titer < 100. Baseline was defined as the last pre-dose measurement.

  12. Number of Participants With Neutralizing Antibodies (NAb) Against PF-07261271: SAD Cohort

    Time frame: Baseline up to 15 months

    NAb was determined by electrochemiluminescent (ECL) competitive ligand binding assay using the Meso Scale Discovery (MSD) platform.

  13. Number of Participants With NAb Against PF-07261271: MD Cohort

    Time frame: Baseline up to 15.5 months

    NAb was determined by electrochemiluminescent (ECL) competitive ligand binding assay using the Meso Scale Discovery (MSD) platform.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR OPEN, PLACEBO CONTROLLED, DOSE ESCALATING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SINGLE INTRAVENOUS AND MULTIPLE SUBCUTANEOUS AND INTRAVENOUS DOSES OF PF-07261271 IN HEALTHY PARTICIPANTS

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 10, 2022
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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