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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
Must not have
History of HIV infection, hepatitis B, or hepatitis C
Previous study drug administration within 30 days or 5 half-lives of first planned dose
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to study completion (approximately 471 days)

Summary

This trial is testing a new medicine called PF-07261271 to see if it is safe and effective for patients with Inflammatory Bowel Disease by reducing inflammation in their digestive system.

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a history of HIV, hepatitis B, or hepatitis C.
Select...
I haven't taken any experimental drugs within the last 30 days or 5 half-lives.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for inflammatory processes, such as those seen in Inflammatory Bowel Disease (IBD), include biologics like infliximab and adalimumab, which target tumor necrosis factor-alpha (TNF-alpha) to reduce inflammation. Other treatments include immunomodulators like azathioprine and methotrexate, which suppress the immune system to prevent inflammatory responses. Understanding these mechanisms is crucial for healthy subjects as it helps in assessing the safety and potential side effects of new treatments like PF-07261271, ensuring that they do not adversely affect normal immune function while aiming to modulate inflammation.
[Physiopathology and new treatments of septic shock].Atherothrombosis Prevention and Treatment with Anti-interleukin-1 Agents.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor
4,669 Previous Clinical Trials
17,861,889 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,553 Previous Clinical Trials
14,902,891 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
~11 spots leftby Dec 2025