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

NCT05536440 | Completed Phase 1 Results FDA Drug

• 1 other identifier: C4631001
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Healthy

Keywords

Healthy volunteer; Healthy; IBD; Inflammatory bowel disease

Outcome Measures

Primary Outcomes (10)

• 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

• 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

Secondary Outcomes (13)

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

  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 Serum Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-07261271: SAD Cohort

  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

  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

  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

  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

Study Arms (16)

Cohort 1 active

EXPERIMENTAL

Dose A

Drug: PF-07261271

Cohort 1 placebo

PLACEBO COMPARATOR

Dose A

Drug: Placebo

Cohort 2 active

EXPERIMENTAL

Dose B

Drug: PF-07261271

Cohort 2 placebo

PLACEBO COMPARATOR

Dose B

Drug: Placebo

Cohort 3 active

EXPERIMENTAL

Dose C

Drug: PF-07261271

Cohort 3 placebo

PLACEBO COMPARATOR

Dose C

Drug: Placebo

Cohort 4 active

EXPERIMENTAL

Dose D

Drug: PF-07261271

Cohort 4 placebo

PLACEBO COMPARATOR

Dose D

Drug: Placebo

Cohort 5 active

EXPERIMENTAL

Dose E

Drug: PF-07261271

Cohort 5 placebo

PLACEBO COMPARATOR

Dose E

Drug: Placebo

Cohort 6 active

EXPERIMENTAL

Dose F

Drug: PF-07261271

Cohort 6 placebo

PLACEBO COMPARATOR

Dose F

Drug: Placebo

Cohort 7 active

EXPERIMENTAL

Dose G

Drug: PF-07261271

Cohort 7 placebo

PLACEBO COMPARATOR

Dose G

Drug: Placebo

Cohort 8 active

EXPERIMENTAL

Dose H

Drug: PF-07261271

Cohort 8 placebo

PLACEBO COMPARATOR

Dose H

Drug: Placebo

Interventions

PF-07261271 DRUG

IV or SC

Cohort 1 active; Cohort 2 active; Cohort 3 active; Cohort 4 active; Cohort 5 active; Cohort 6 active; Cohort 7 active; Cohort 8 active

Placebo DRUG

IV or SC

Cohort 1 placebo; Cohort 2 placebo; Cohort 3 placebo; Cohort 4 placebo; Cohort 5 placebo; Cohort 6 placebo; Cohort 7 placebo; Cohort 8 placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (4)

Orange County Research Center

Lake Forest, California, 92630, United States

Location

Orange County Research Center

Tustin, California, 92780, United States

Location

Clinilabs

Eatontown, New Jersey, 07724, United States

Location

ICON

Salt Lake City, Utah, 84124, United States

Location

Related Links

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

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 10, 2022
• Study Start: October 17, 2022
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: March 24, 2025
• Results First Posted: March 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)