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

Keywords

• Healthy volunteer
• Healthy
• IBD
• Inflammatory bowel disease

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Study arms

• Experimental
  Cohort 1 active

  Dose A

  Drug: PF-07261271

• Placebo comparator
  Cohort 1 placebo

  Dose A

  Drug: Placebo

• Experimental
  Cohort 2 active

  Dose B

  Drug: PF-07261271

• Placebo comparator
  Cohort 2 placebo

  Dose B

  Drug: Placebo

• Experimental
  Cohort 3 active

  Dose C

  Drug: PF-07261271

• Placebo comparator
  Cohort 3 placebo

  Dose C

  Drug: Placebo

• Experimental
  Cohort 4 active

  Dose D

  Drug: PF-07261271

• Placebo comparator
  Cohort 4 placebo

  Dose D

  Drug: Placebo

• Experimental
  Cohort 5 active

  Dose E

  Drug: PF-07261271

• Placebo comparator
  Cohort 5 placebo

  Dose E

  Drug: Placebo

• Experimental
  Cohort 6 active

  Dose F

  Drug: PF-07261271

• Placebo comparator
  Cohort 6 placebo

  Dose F

  Drug: Placebo

• Experimental
  Cohort 7 active

  Dose G

  Drug: PF-07261271

• Placebo comparator
  Cohort 7 placebo

  Dose G

  Drug: Placebo

• Experimental
  Cohort 8 active

  Dose H

  Drug: PF-07261271

• Placebo comparator
  Cohort 8 placebo

  Dose H

  Drug: Placebo

Interventions

• DrugPF-07261271

  IV or SC

• DrugPlacebo

  IV or SC

Primary outcomes

1. 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.

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

2. 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.

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

3. 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.

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

4. 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.

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

5. 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.

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

6. 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.

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

7. 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.

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

8. 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.

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

9. 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.

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

10. 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.

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

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

   AUClast was determined using Linear Log trapezoidal method.

   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

2. 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.

   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

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

   Cmax was defined as maximum serum concentration.

   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

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

   Tmax was defined as time for Cmax.

   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

5. 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.

   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

6. 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.

   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

7. Cmax of PF-07261271: MD Cohort

   Cmax was defined as maximum serum concentration.

   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

8. Tmax of PF-07261271: MD Cohort

   Tmax was defined as time for Cmax.

   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

9. 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.

   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

10. 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

    Time frame: Baseline up to 15 months

11. 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.

    Time frame: Baseline up to 15.5 months

12. 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.

    Time frame: Baseline up to 15 months

13. 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.

    Time frame: Baseline up to 15.5 months

Baseline characteristics

Related links

• To obtain contact information for a study center near you, click here. ↗

Study documents

• Study protocol · Oct 19, 2023
• Statistical analysis plan · Apr 18, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — 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.