PF-07314470 for Healthy Subjects

Overseen By Pfizer CT.gov Call Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Pfizer

Must not be taking: Prohibited medications

Disqualifiers: Medical conditions, Alcohol abuse, Drug use, others

Compensation: Varies

Number of Visits: 2

Duration: 9 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the safety and behavior of a new medicine, PF-07314470, in the bodies of healthy individuals. Participants will receive either the medicine or a placebo (inactive substance) in varying doses to observe the body's response. The trial seeks healthy individuals without significant medical issues who do not use tobacco or alcohol excessively. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial excludes participants who have used any prohibited medications, but it does not specify which medications are prohibited. It's best to discuss your current medications with the trial team to see if they are allowed.

Is there any evidence suggesting that PF-07314470 is likely to be safe for humans?

Research shows that PF-07314470 is a new treatment currently being tested for safety in humans. Specific information about its safety in humans is not yet available. This trial is in its early stages, where testing begins with healthy volunteers to observe how the body reacts.

Early trials primarily focus on safety. If the treatment were unsafe, it would not have reached this stage. However, detailed safety information is not yet available due to the trial's early phase. Participants might experience mild reactions, which is normal in these studies. For questions or concerns, discussing them with the research team or a doctor is advisable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about PF-07314470 because it introduces a potentially novel approach to treatment, targeting specific pathways that are not addressed by current therapies. Unlike standard treatments that might focus on broader mechanisms, PF-07314470 is designed to work precisely, which could lead to more effective results with fewer side effects. Additionally, the flexibility in dosing—ranging from single doses to more frequent administration—offers a tailored approach that might better meet the needs of different patient groups. This specificity and adaptability are what set PF-07314470 apart and generate excitement in the medical community.

What evidence suggests that PF-07314470 could be effective?

Research on PF-07314470 remains in the early stages, providing limited information on its effectiveness for specific health issues. This trial includes various treatment arms, with participants receiving different dosing regimens of PF-07314470 or a placebo. The primary focus is on understanding the drug's behavior in the body and assessing its safety. Studies have suggested that PF-07314470 affects certain biological processes, potentially making it useful for future treatments. Initial results from tests on healthy volunteers have helped determine the best doses to use. Further research is necessary to evaluate the treatment's effectiveness for any medical conditions. ^{1 2 3 5 6}

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 Japanese adults with all four grandparents born in Japan. Men must be aged 18-45 and women 18-55, with a BMI of 16-32 kg/m2 and weight over 50 kg (110 lb), or over 45 kg for Japanese participants.

Inclusion Criteria

For Japanese participants only, enrolling as Japanese must have 4 biological grandparents who were born in Japan.

I am a healthy male aged 18-45 or a healthy female aged 18-55.

My BMI is between 16-32, and I weigh more than 110 lb (or more than 45 kg if I am Japanese).

Exclusion Criteria

History of alcohol abuse or repeated binge drinking and/or any other illicit drug use or dependence within 6 months of screening

Pregnant or breastfeeding females, males with partners currently pregnant, or males or females pursuing artificial reproductive technologies

Use of tobacco/nicotine containing products in excess of the equivalent of 5 cigarettes/day or 2 chews of tobacco/day

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single or multiple doses of PF-07314470 or placebo

9 weeks

Weekly visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• PF-07314470

Trial Overview The study is testing PF-07314470 to see if it's safe and how it behaves inside the body when taken by healthy people. Some will get the actual medicine while others will receive a placebo, which has no active ingredients.

How Is the Trial Designed?

Group I: PF-07314470; Cohorts 9 to 13 Experimental Treatment 1 Intervention

Participants will receive PF-07314470 weekly at 1 of 4 dose levels for 4 doses, or every 2 weeks at 1 dose level for 3 doses.

Group II: PF-07314470; Cohorts 1 to 7, optional Cohort 8 and optional Japanese Cohort 14 Experimental Treatment 1 Intervention

Participants will receive a single dose of PF-07314470 at 1 of 7 dose levels

Group III: Placebo for PF-07314470; Cohorts 1 to 7, optional Cohort 8 and optional Japanese Cohort 14 Placebo Group 1 Intervention

Participants will receive a single dose of placebo for PF-07314470

Group IV: Placebo for PF-07314470; Cohorts 9 to 13 Placebo Group 1 Intervention

Participants will receive placebo for PF-07314470 weekly for 4 doses, or every 2 weeks for 3 doses.

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06821750?term=PF-07314470&rank=1

NCT06821750 | A Study to Learn How Different Amounts of ... The purpose of this clinical trial is to learn if the study medicine (called PF-07314470 ) is safe and how it gets in and out of the body in healthy people.

2. trial.medpath.com trial.medpath.com/drug/report/a363c6b4b7e99d24

PF-07314470 | Advanced Drug Monograph - MedPath Comprehensive analysis about PF-07314470, including its mechanisms, clinical uses, and therapeutic considerations.

3. withpower.com withpower.com/trial/pf-07314470-for-healthy-subjects-9e406

PF-07314470 for Healthy Subjects · Info for Participants The purpose of this clinical trial is to learn if the study medicine (called PF-07314470) is safe and how it gets in and out of the body in healthy people. Show ...

4. cdn.pfizer.com cdn.pfizer.com/pfizercom/product-pipeline/Q2%202025%20Pipeline%20Update_vFinal3.pdf?VersionId=.vWSG4GS6qUYxj4lb2OAwbivw9Kx0y5s

Q2 2025 Pipeline Update_vFinal3.pdf Pfizer announced statistically significant and clinically meaningful survival results from the Phase 3 BREAKWATER trial evaluating BRAFTOVI® ( ...

5. trialstoday.org trialstoday.org/trial/NCT06821750

A Study to Learn How Different Amounts ... The purpose of this clinical trial is to learn if the study medicine (called PF-07314470) is safe and how it gets in and out of the body in ...

6. trial.medpath.com trial.medpath.com/drug/a363c6b4b7e99d24/pf-07314470

PF-07314470 - MedPath This New Molecular Entity is designed to simultaneously modulate two key cytokine pathways implicated in inflammatory and autoimmune disorders: ...