PF-07275315 in Healthy Subjects

No longer recruiting at 5 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Pfizer

Disqualifiers: HIV, Hepatitis B, Hepatitis C, others

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 541 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand the safety and effects of a new medicine, PF-07275315 (an experimental treatment), in healthy individuals. Researchers will randomly divide participants into groups to receive either the actual medicine or a placebo (a harmless treatment with no medical effect) through an IV infusion. The trial suits those who are healthy, can commit to the study schedule, and have a BMI between 17.5 and 32, with a body weight over 110 pounds. The study lasts up to 541 days, with follow-up visits occurring 271 days after the first treatment. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the unique opportunity to be among the first to receive this new medicine.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study is for healthy participants, it's possible that taking other medications might not be allowed. Please check with the study coordinators for specific guidance.

Is there any evidence suggesting that PF-07275315 is likely to be safe for humans?

Research shows that PF-07275315 remains under evaluation for safety in humans. Some studies examine how well participants tolerate the treatment and monitor for side effects. Since this trial is in an early stage, it primarily assesses the treatment's safety in healthy individuals. The dose increases only if deemed safe at lower levels.

This trial represents an initial step in ensuring PF-07275315's safe use. Researchers closely monitor participants to detect any potential side effects early. This careful approach helps determine if the treatment is safe enough for further testing. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

PF-07275315 is unique because it brings a new mechanism of action to the table for treating conditions that typically rely on standard medications. Unlike most current treatments, which might focus on symptoms, PF-07275315 targets the underlying causes at a molecular level, potentially offering more effective and long-lasting relief. Researchers are especially excited because this approach could lead to fewer side effects and quicker results, making it a promising option for patients seeking alternatives to traditional therapies.

What evidence suggests that PF-07275315 could be effective?

Research is investigating PF-07275315, which participants in this trial may receive, to determine its potential in treating conditions like atopic dermatitis, known for causing itchy and inflamed skin. Early studies focus on assessing the safety of this medicine and its possible effects. Although data on its effectiveness for specific conditions remains limited, the medicine is being developed for its potential impact on biological processes related to inflammation. This development gives researchers hope that it could help reduce symptoms in conditions like atopic dermatitis. Initial findings from studies with healthy individuals primarily address safety, marking an important step toward understanding how well PF-07275315 might treat certain conditions. ^{1 2 6 7 8}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

Healthy individuals who have a BMI of 17.5 to 32 and weigh over 110 pounds can join this study. They must be free from significant recent trauma, major surgeries, TB, HIV, hepatitis B or C, and cannot have current or past malignancies except for certain skin cancers or cervical carcinoma in situ.

Inclusion Criteria

Participants who are overtly healthy as determined by medical evaluation

I am willing and able to follow all study requirements.

My BMI is between 17.5 and 32, and I weigh more than 110 pounds.

Exclusion Criteria

I have not had major surgery or significant trauma in the last month.

I have a history of infections or currently have an infection.

I have no cancer history except for certain skin cancers or treated cervical cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single and multiple escalating doses of PF-07275315 or placebo

Up to 541 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

271 days

What Are the Treatments Tested in This Trial?

Interventions

• PF-07275315
• Placebo

Trial Overview The trial is testing PF-07275315's safety and effects compared to a placebo in healthy people. Participants will receive either the drug or placebo through an IV infusion across different groups with increasing doses deemed safe by the sponsor.

How Is the Trial Designed?

Group I: Active Experimental Treatment 1 Intervention

PF-07275315

Group II: Placebo Placebo Group 1 Intervention

Placebo

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

In two phase 3 trials involving 1379 patients with moderate-to-severe atopic dermatitis, dupilumab significantly improved skin condition and quality of life compared to placebo, with 37-38% of patients achieving clear or almost clear skin at 16 weeks.

While dupilumab was effective in reducing symptoms like itching and anxiety, it was associated with more injection-site reactions and conjunctivitis compared to placebo, indicating a need for monitoring side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis. Simpson, EL., Bieber, T., Guttman-Yassky, E., et al.[2022]

Dupilumab significantly improves lung function and asthma control in patients with moderate to severe asthma, as evidenced by better forced expiratory volume and asthma control questionnaire scores over 12 and 24 weeks in 13 trials.

The treatment is generally safe, showing no significant increase in adverse events compared to placebo, although it was associated with higher blood eosinophil levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab efficacy and safety in patients with moderate to severe asthma: A systematic review and meta-analysis. Zaazouee, MS., Alwarraqi, AG., Mohammed, YA., et al.[2022]

In a phase 3 study involving patients with uncontrolled, moderate-to-severe asthma, dupilumab significantly reduced asthma exacerbation rates by 35-67% and improved lung function (FEV1) across various subgroups, including those with different levels of allergen sensitization.

Dupilumab also effectively lowered levels of biomarkers associated with asthma, such as fractional exhaled nitric oxide (FeNO) and total IgE, demonstrating its efficacy regardless of whether patients were sensitized to allergens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab Efficacy in Patients with Uncontrolled Moderate-to-Severe Type 2 Asthma Regardless of Perennial Aeroallergen Sensitization. Corren, J., Jackson, DJ., Casale, TB., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05995964

NCT05995964 | A Study To Learn About Two ... The purpose of this study is to learn about the safety and effects of 2 study medicines (PF-07275315 and PF-07264660) for the treatment of atopic dermatitis ...

2. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-5-2022-ff42f

PF-07275315 in Healthy Subjects · Info for Participants This trial tests a new medicine called PF-07275315 in healthy adults to see if it is safe. The medicine is given in increasing amounts to observe its effects.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06977581

NCT06977581 | A Study to Learn About the ... The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07275315) for the potential treatment of moderate- ...

4. trial.medpath.com trial.medpath.com/drug/report/7fa2d3f55f01cb46

PF-07275315 | Advanced Drug Monograph - MedPath Comprehensive analysis about PF-07275315, including its mechanisms, clinical uses, and therapeutic considerations.

5. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-effects-of-pf-07275315-and-pf-07264660-for-adults-with-moderate-to-severe-atopic-dermatitis/

Study on the Effects of PF-07275315 and PF-07264660 for ... The purpose of the study is to evaluate how effective and safe these treatments are compared to a placebo in adults with moderate to severe ...

6. mountsinai.org mountsinai.org/clinical-trials/study-to-learn-about-two-study-medicines-pf-07275315-pf-07264660-in-people-who-have-moderate-to-severe-atopic-dermatitis

A Study To Learn About Two Study Medicines (PF ... The purpose of this study is to learn about the safety and effects of 2 study medicines (PF-07275315 and PF-07264660) for the treatment of atopic dermatitis ( ...

7. ctv.veeva.com ctv.veeva.com/study/a-study-to-learn-about-the-study-medicine-called-pf-07275315-in-people-with-moderate-to-severe-asthm

A Study to Learn About the Study Medicine Called PF ... The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07275315) for the potential treatment of moderate- ...

8. trial.medpath.com trial.medpath.com/clinical-trial/f2c7b23ccaf467a0

A Study to Learn How the Study Medicine Called PF-07275315 ... The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07275315) in healthy participants.