PF-07261271 for Healthy Subjects

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

35 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

What makes the drug PF-07261271 unique compared to other treatments?

The drug PF-07261271 is unique because it is being tested in healthy subjects, which is different from typical trials that focus on patients with specific conditions. This approach may help understand its effects and safety profile in a broader population before targeting specific diseases. ^{1 2 3 4 5}

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. England pubmed.ncbi.nlm.nih.gov

Similar Pharmacokinetics of the Adalimumab (Humira®) Biosimilar BI 695501 Whether Administered via Subcutaneous Autoinjector or Prefilled Syringe (VOLTAIRE®-AI and VOLTAIRE®-TAI): Phase 1, Randomized, Open-Label, Parallel-Group Trials. [2020]

2. Germany pubmed.ncbi.nlm.nih.gov

The pharmacokinetics and pharmacodynamics of PF-00734200, a DPP-IV inhibitor, in healthy Japanese subjects. [2014]

3. United States pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Needle-free Powder Lidocaine Delivery System in Adult Patients Undergoing Venipuncture or Peripheral Venous Cannulation: A Randomized, Double-Blind, Placebo-controlled Trial. [2016]

4. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of the dipeptidyl peptidase-4 inhibitor PF-734200 added to metformin in Type 2 diabetes. [2014]

5. United States 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. [2023]