PF-07261271 for Healthy Subjects

No longer recruiting at 4 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Pfizer

Disqualifiers: HIV, Hepatitis B/C, Hypertension, others

Compensation: Varies

Number of Visits: Unknown

Duration: 15 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effects of a new medicine, PF-07261271, which could help treat Inflammatory Bowel Disease (IBD). Participants will receive either the actual medicine at different doses or a placebo (a harmless pill with no active drug) to observe reactions. The trial is for healthy individuals who weigh over 110 pounds and do not have any serious health issues. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but since it is for healthy individuals, you might not be on any regular medications. It's best to discuss your specific situation with the trial coordinators.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In a previous study, researchers found that PF-07261271 was generally safe and well-tolerated by healthy participants. They tested both single and multiple doses of the treatment. Participants did not experience serious side effects. The study examined how the body processed the drug and how participants felt afterward. While no treatment is completely risk-free, the data suggests that PF-07261271 is safe for humans at the doses tested. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

PF-07261271 is unique because it offers a new approach to targeting the underlying mechanisms of certain conditions that current treatments may not address effectively. Unlike standard therapies that often focus on symptom management, PF-07261271 potentially targets the root cause more directly, possibly leading to more effective outcomes. Additionally, its specific mechanism of action or potentially novel active ingredient may provide benefits such as quicker results or fewer side effects, which is why researchers are eager to see its full potential in clinical settings.

What evidence suggests that this trial's treatments could be effective for Inflammatory Bowel Disease?

Research has shown that PF-07261271 is being explored as a possible treatment for Inflammatory Bowel Disease by reducing inflammation. This treatment has generally been safe and well-tolerated in healthy individuals. However, the current trial focuses on testing PF-07261271 in healthy subjects, so information on its effectiveness for Inflammatory Bowel Disease remains limited. The medicine targets specific parts of the body's inflammation process. While early studies provide some safety information, more research is needed to confirm its benefits for people with Inflammatory Bowel Disease. ^{1 2 4 6 7}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Healthy individuals as determined by medical evaluation

My BMI is between 17.5 and 30.5, and I weigh more than 110 lbs.

Exclusion 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.

BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single intravenous and multiple subcutaneous and intravenous doses of PF-07261271

15 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PF-07261271
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: Cohort 8 active Experimental Treatment 1 Intervention

Dose H

Group II: Cohort 7 active Experimental Treatment 1 Intervention

Dose G

Group III: Cohort 6 active Experimental Treatment 1 Intervention

Dose F

Group IV: Cohort 5 active Experimental Treatment 1 Intervention

Dose E

Group V: Cohort 4 active Experimental Treatment 1 Intervention

Dose D

Group VI: Cohort 3 active Experimental Treatment 1 Intervention

Dose C

Group VII: Cohort 2 active Experimental Treatment 1 Intervention

Dose B

Group VIII: Cohort 1 active Experimental Treatment 1 Intervention

Dose A

Group IX: Cohort 2 placebo Placebo Group 1 Intervention

Dose B

Group X: Cohort 7 placebo Placebo Group 1 Intervention

Dose G

Group XI: Cohort 4 placebo Placebo Group 1 Intervention

Dose D

Group XII: Cohort 8 placebo Placebo Group 1 Intervention

Dose H

Group XIII: Cohort 6 placebo Placebo Group 1 Intervention

Dose F

Group XIV: Cohort 3 placebo Placebo Group 1 Intervention

Dose C

Group XV: Cohort 5 placebo Placebo Group 1 Intervention

Dose E

Group XVI: Cohort 1 placebo Placebo Group 1 Intervention

Dose A

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Published Research Related to This Trial

The study found that auto-injector systems (A-INJ) effectively delivered both placebo and active injectates while maintaining blinding in randomized controlled trials, with no significant difference in delivery rates compared to conventional syringes.

Investigators reported no concerns about becoming unblinded when using the A-INJ, highlighting its potential to improve the integrity of clinical trials without the need for additional modifications to the placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blinding Is Seeing: A Single-Centre Study Into the Viability of Auto-Injectors for Blinded-Drug Administration in Randomised Controlled Trials. Aggarwal, V., Taubel, J., Lorch, U., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05536440

NCT05536440 | A Study to Learn About ... 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 ...

2. pfizer.com pfizer.com/sites/default/files/plsr-studies/C4631001%20Plain%20Language%20Study%20Results%20Summary%20%28PLSRS%29%20Phase%201%20PK%20Primary%20Endpoint.pdf

Clinical Study Results This study found that single and multiple doses of PF-07261271 were generally safe and tolerated by healthy participants. The researchers found ...

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/40/NCT05536440/SAP_001.pdf

Protocol C4631001 (PF-07261271) Statistical Analysis Plan This is the first time PF-07261271 will be given to humans. The purpose of the study is to evaluate the safety, tolerability, PK, and PD of ...

4. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-9-2022-5f641

PF-07261271 for Healthy Subjects · Info for Participants 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 ...

5. pfizer.com pfizer.com/science/clinical-trials/data-and-results/trial-results

Clinical Study Report Synopses Pfizer is making electronic synopses of CSRs publicly available on this website. They include the synopsis of the CSR submitted to the regulatory agency.

6. ctv.veeva.com ctv.veeva.com/study/a-study-to-learn-about-study-medicine-called-pf-07261271-in-healthy-people

A Study to Learn About Study Medicine Called PF-07261271 ... 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 ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/40/NCT05536440/Prot_000.pdf

PF-07261271 - Protocol C4631001 The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of escalating single and multiple doses of PF-07261271 ...