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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 belowSelect...
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)
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 moreTrial 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.
[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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a serious medical condition that could affect your ability to participate in the study or put you at risk.I have a history of HIV, hepatitis B, or hepatitis C.You have a history of drug or alcohol abuse, or you smoke more than 20 cigarettes per day.My BMI is between 17.5 and 30.5, and I weigh more than 110 lbs.I haven't taken any experimental drugs within the last 30 days or 5 half-lives.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2 placebo
- Group 2: Cohort 3 active
- Group 3: Cohort 7 placebo
- Group 4: Cohort 4 placebo
- Group 5: Cohort 5 active
- Group 6: Cohort 8 placebo
- Group 7: Cohort 6 placebo
- Group 8: Cohort 6 active
- Group 9: Cohort 7 active
- Group 10: Cohort 8 active
- Group 11: Cohort 3 placebo
- Group 12: Cohort 5 placebo
- Group 13: Cohort 2 active
- Group 14: Cohort 1 active
- Group 15: Cohort 1 placebo
- Group 16: Cohort 4 active
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.