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

NCT ID: NCT05536440

Last Updated: 2025-03-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-17

Study Completion Date

2024-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1 active

Dose A

Group Type EXPERIMENTAL

PF-07261271

Intervention Type DRUG

IV or SC

Cohort 1 placebo

Dose A

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

IV or SC

Cohort 2 active

Dose B

Group Type EXPERIMENTAL

PF-07261271

Intervention Type DRUG

IV or SC

Cohort 2 placebo

Dose B

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

IV or SC

Cohort 3 active

Dose C

Group Type EXPERIMENTAL

PF-07261271

Intervention Type DRUG

IV or SC

Cohort 3 placebo

Dose C

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

IV or SC

Cohort 4 active

Dose D

Group Type EXPERIMENTAL

PF-07261271

Intervention Type DRUG

IV or SC

Cohort 4 placebo

Dose D

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

IV or SC

Cohort 5 active

Dose E

Group Type EXPERIMENTAL

PF-07261271

Intervention Type DRUG

IV or SC

Cohort 5 placebo

Dose E

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

IV or SC

Cohort 6 active

Dose F

Group Type EXPERIMENTAL

PF-07261271

Intervention Type DRUG

IV or SC

Cohort 6 placebo

Dose F

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

IV or SC

Cohort 7 active

Dose G

Group Type EXPERIMENTAL

PF-07261271

Intervention Type DRUG

IV or SC

Cohort 7 placebo

Dose G

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

IV or SC

Cohort 8 active

Dose H

Group Type EXPERIMENTAL

PF-07261271

Intervention Type DRUG

IV or SC

Cohort 8 placebo

Dose H

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

IV or SC

Interventions

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PF-07261271

IV or SC

Intervention Type DRUG

Placebo

IV or SC

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Orange County Research Center

Lake Forest, California, United States

Site Status

Orange County Research Center

Tustin, California, United States

Site Status

Clinilabs

Eatontown, New Jersey, United States

Site Status

ICON

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=C4631001

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

Other Identifiers

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C4631001

Identifier Type: -

Identifier Source: org_study_id

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