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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: PF-07261271; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Lake Forest, California, United States, 92630
      • Orange County Research Center
    • Tustin, California, United States, 92780
      • Orange County Research Center
  • New Jersey
    • Eatontown, New Jersey, United States, 07724
      • Clinilabs
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • ICON

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

16

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1 active; Dose A	Drug: PF-07261271; IV or SC
Placebo Comparator: Cohort 1 placebo; Dose A	Drug: Placebo; IV or SC
Experimental: Cohort 2 active; Dose B	Drug: PF-07261271; IV or SC
Placebo Comparator: Cohort 2 placebo; Dose B	Drug: Placebo; IV or SC
Experimental: Cohort 3 active; Dose C	Drug: PF-07261271; IV or SC
Placebo Comparator: Cohort 3 placebo; Dose C	Drug: Placebo; IV or SC
Experimental: Cohort 4 active; Dose D	Drug: PF-07261271; IV or SC
Placebo Comparator: Cohort 4 placebo; Dose D	Drug: Placebo; IV or SC
Experimental: Cohort 5 active; Dose E	Drug: PF-07261271; IV or SC
Placebo Comparator: Cohort 5 placebo; Dose E	Drug: Placebo; IV or SC
Experimental: Cohort 6 active; Dose F	Drug: PF-07261271; IV or SC
Placebo Comparator: Cohort 6 placebo; Dose F	Drug: Placebo; IV or SC
Experimental: Cohort 7 active; Dose G	Drug: PF-07261271; IV or SC
Placebo Comparator: Cohort 7 placebo; Dose G	Drug: Placebo; IV or SC
Experimental: Cohort 8 active; Dose H	Drug: PF-07261271; IV or SC
Placebo Comparator: Cohort 8 placebo; Dose H	Drug: Placebo; IV or SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	Baseline up to study completion (approximately 471 days)
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities	Baseline up to study completion (approximately 471 days)
Number of Participants With Clinically Significant Change From Baseline in Vital Signs	Baseline up to study completion (approximately 471 days)
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings	Baseline up to study completion (approximately 471 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	Single Ascending Cohorts	Baseline up to study completion (approximately 451 days)
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)	Single Ascending Cohorts	Baseline up to study completion (approximately 451 days)
Area Under the Curve from Time Zero to end of dosing interval (AUCtau)	Multiple Dose Cohorts	Baseline up to study completion (approximately 471 days)
Maximum Observed Plasma Concentration (Cmax)	Single Ascending and Multiple Dose Cohorts	Baseline up to study completion (approximately 471 days)
Time to Reach Maximum Observed Plasma Concentration (Tmax)	Single Ascending and Multiple Dose Cohorts	Baseline up to study completion (approximately 471 days)
Plasma Decay Half-Life (t1/2)	Single Ascending and Multiple Dose Cohorts	Baseline up to study completion (approximately 471 days)
Incidence of Anti-Drug Antibody (ADA)	The percentage of participants with positive ADA and neutralizing antibodies will be summarized for each treatment arm.	Baseline up to study completion (approximately 471 days)

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2022
• Primary Completion (Actual): February 29, 2024
• Study Completion (Actual): February 29, 2024

Study Registration Dates

• First Submitted: September 7, 2022
• First Submitted That Met QC Criteria: September 7, 2022
• First Posted (Actual): September 10, 2022

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Healthy; IBD; Inflammatory bowel disease; Healthy volunteer
• Other Study ID Numbers: C4631001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No