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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05536440
Recruitment Status : Recruiting
First Posted : September 10, 2022
Last Update Posted : May 3, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Drug: PF-07261271 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : October 17, 2022
Estimated Primary Completion Date : August 30, 2024
Estimated Study Completion Date : August 30, 2024
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to study completion (approximately 471 days) ]
  2. Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities [ Time Frame: Baseline up to study completion (approximately 471 days) ]
  3. Number of Participants With Clinically Significant Change From Baseline in Vital Signs [ Time Frame: Baseline up to study completion (approximately 471 days) ]
  4. Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings [ Time Frame: Baseline up to study completion (approximately 471 days) ]

Secondary Outcome Measures :
  1. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: Baseline up to study completion (approximately 451 days) ]
    Single Ascending Cohorts

  2. Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) [ Time Frame: Baseline up to study completion (approximately 451 days) ]
    Single Ascending Cohorts

  3. Area Under the Curve from Time Zero to end of dosing interval (AUCtau) [ Time Frame: Baseline up to study completion (approximately 471 days) ]
    Multiple Dose Cohorts

  4. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Baseline up to study completion (approximately 471 days) ]
    Single Ascending and Multiple Dose Cohorts

  5. Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Baseline up to study completion (approximately 471 days) ]
    Single Ascending and Multiple Dose Cohorts

  6. Plasma Decay Half-Life (t1/2) [ Time Frame: Baseline up to study completion (approximately 471 days) ]
    Single Ascending and Multiple Dose Cohorts

  7. Incidence of Anti-Drug Antibody (ADA) [ Time Frame: Baseline up to study completion (approximately 471 days) ]
    The percentage of participants with positive ADA and neutralizing antibodies will be summarized for each treatment arm.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05536440


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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United States, California
Orange County Research Center Recruiting
Tustin, California, United States, 92780
United States, New Jersey
Clinilabs Recruiting
Eatontown, New Jersey, United States, 07724
United States, Utah
ICON Recruiting
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05536440    
Other Study ID Numbers: C4631001
First Posted: September 10, 2022    Key Record Dates
Last Update Posted: May 3, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Healthy volunteer
Healthy
IBD
Inflammatory bowel disease