← Back to Search

Unknown

PF-07261271 for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to study completion (approximately 471 days)
Awards & highlights

Study Summary

This trial tests a potential medication to treat Inflammatory Bowel Disease and evaluate its safety and effects.

Who is the study for?
This trial is for healthy individuals with a BMI of 17.5 to 30.5 and weight over 50 kg (110 lb). Participants must not have high blood pressure, significant ECG abnormalities, HIV, hepatitis B or C, a history of substance abuse including heavy smoking, or other serious health issues.Check my eligibility
What is being tested?
The study is testing PF-07261271 against a placebo to evaluate its safety and potential effects as a treatment for Inflammatory Bowel Disease in healthy participants.See study design
What are the potential side effects?
While the specific side effects are not listed here, common ones may include reactions at the injection site, nausea, headaches, or fatigue. The trial aims to identify any adverse effects of PF-07261271.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My BMI is between 17.5 and 30.5, and I weigh more than 110 lbs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to study completion (approximately 471 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to study completion (approximately 471 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
+1 more
Secondary outcome measures
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
+4 more

Trial Design

16Treatment groups
Experimental Treatment
Placebo Group
Group I: Cohort 8 activeExperimental Treatment1 Intervention
Dose H
Group II: Cohort 7 activeExperimental Treatment1 Intervention
Dose G
Group III: Cohort 6 activeExperimental Treatment1 Intervention
Dose F
Group IV: Cohort 5 activeExperimental Treatment1 Intervention
Dose E
Group V: Cohort 4 activeExperimental Treatment1 Intervention
Dose D
Group VI: Cohort 3 activeExperimental Treatment1 Intervention
Dose C
Group VII: Cohort 2 activeExperimental Treatment1 Intervention
Dose B
Group VIII: Cohort 1 activeExperimental Treatment1 Intervention
Dose A
Group IX: Cohort 2 placeboPlacebo Group1 Intervention
Dose B
Group X: Cohort 7 placeboPlacebo Group1 Intervention
Dose G
Group XI: Cohort 4 placeboPlacebo Group1 Intervention
Dose D
Group XII: Cohort 8 placeboPlacebo Group1 Intervention
Dose H
Group XIII: Cohort 6 placeboPlacebo Group1 Intervention
Dose F
Group XIV: Cohort 3 placeboPlacebo Group1 Intervention
Dose C
Group XV: Cohort 5 placeboPlacebo Group1 Intervention
Dose E
Group XVI: Cohort 1 placeboPlacebo Group1 Intervention
Dose A
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PF-07261271
2022
Completed Phase 1
~40

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor
4,567 Previous Clinical Trials
10,911,838 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,093,006 Total Patients Enrolled

Media Library

PF-07261271 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05536440 — Phase 1
Healthy Subjects Research Study Groups: Cohort 2 placebo, Cohort 3 active, Cohort 7 placebo, Cohort 4 placebo, Cohort 5 active, Cohort 8 placebo, Cohort 6 placebo, Cohort 6 active, Cohort 7 active, Cohort 8 active, Cohort 3 placebo, Cohort 5 placebo, Cohort 2 active, Cohort 1 active, Cohort 1 placebo, Cohort 4 active
Healthy Subjects Clinical Trial 2023: PF-07261271 Highlights & Side Effects. Trial Name: NCT05536440 — Phase 1
PF-07261271 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05536440 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what degree does Cohort 6 have a beneficial impact on patients' wellbeing?

"Due to the early-stage nature of this trial, Cohort 6 active has been assigned a score of 1 by our experts at Power. This indicates that there is limited evidence supporting its safety and efficacy."

Answered by AI

To what extent is participation in this medical trial being observed?

"Affirmative. Clinicaltrials.gov data reveals that this trial, initially posted on October 17th 2022, is still accepting new participants. There are 3 locations participating in the study and they will collectively accept 51 patients."

Answered by AI

Is there an opportunity to join the experiment for this particular therapy?

"In order to qualify for the trial, participants must possess healthy subject status and be between 18-65 years old. The total number of patients being accepted is 51."

Answered by AI

Does this research encompass individuals of an older age group?

"This trial is strictly open to those aged 18-65, though there are 50 studies available for younger individuals and 372 studies accessible by seniors."

Answered by AI

Is enrollment in this trial still open to volunteers?

"Indeed, clinicaltrials.gov confirms that this research project was launched on October 17th 2022 and is still ongoing. The trial demands 51 volunteers to be recruited from 3 different medical establishments."

Answered by AI

What are the essential aims of this medical experiment?

"The principal objective of this trial, spanning a duration of 471 days from the initial baseline, is to discern how many participants show clinically important disparities in laboratory abnormalities. Other metrics being monitored are plasma decay half-life (t1/2) for both single and multiple dose cohorts, maximum observed plasma concentration (Cmax) which will also be tracked across different dosage levels, as well as area under the curve from time zero to end of dosing interval (AUCτau) just for multiple dose cohorts."

Answered by AI

Who else is applying?

What state do they live in?
Florida
South Dakota
Utah
What site did they apply to?
PRA Health Sciences
Orange County Research Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I've been involved in Clinical Tests for years, this one is of personal interest.
PatientReceived 1 prior treatment
~14 spots leftby Apr 2025