What side effects are associated with this type of intervention?

Common treatments for inflammatory bowel disease (IBD) include 5-aminosalicylic acid (5-ASA) agents such as mesalamine and sulfasalazine, as well as glucocorticoids like prednisone. The side effects of 5-ASA agents can include nausea, headache, fever, rash, pancreatitis, and pneumonitis, with sulfasalazine having a higher incidence of these effects. Glucocorticoids, while effective for short-term relief, are associated with significant long-term side effects such as weight gain, osteoporosis, hypertension, diabetes, and increased risk of infections.

What prior FDA approvals exist?

Prior FDA approvals for treatments targeting inflammatory processes in the context of IBD include biologic agents such as infliximab and vedolizumab, as well as immunomodulators like thiopurines. These drugs are designed to modulate the immune response and reduce inflammation, which is crucial in managing conditions like ulcerative colitis and Crohn's disease. While the specific trial PF-07261271 focuses on healthy subjects, these approved treatments provide a framework for understanding the potential modulation of inflammatory processes in IBD.

What other types of research exist?

Promising novel alternatives to PF-07261271 for the treatment of IBD in 2024 include biologic agents such as vedolizumab, ustekinumab, and golimumab, as well as small molecules like tofacitinib. These treatments have shown efficacy in clinical trials and observational studies for both Crohn's disease and ulcerative colitis.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to study completion (approximately 471 days)

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

0 / 3Eligibility criteria met

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.

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