PF-07275315 in Healthy Subjects

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

65 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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 PF-07275315 (also known as anti-IL4/13/TSLP) safe for humans?

Dupilumab, a similar treatment targeting IL-4 and IL-13, has been shown to be generally safe in both healthy subjects and patients with conditions like asthma and atopic dermatitis, with minimal adverse effects reported. ^{1 2 3 4 5}

How is the drug PF-07275315 different from other treatments?

PF-07275315 is unique because it targets multiple pathways involved in type 2 inflammation by inhibiting IL-4, IL-13, and TSLP, which are key drivers of allergic and atopic diseases. This multi-target approach may offer broader control of inflammation compared to treatments like dupilumab, which primarily targets IL-4 and IL-13. ^{2 5 6 7 8}

What data supports the effectiveness of the drug PF-07275315?

Research on dupilumab, which also targets IL-4 and IL-13, shows it can reduce asthma attacks and improve lung function in people with asthma, and it helps with skin issues in atopic dermatitis. This suggests that PF-07275315, which targets similar pathways, might also be effective in treating conditions driven by similar immune responses. ^{5 8 9 10 11}

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 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]

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]

Citations

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

Efficacy and safety of dupilumab in perennial allergic rhinitis and comorbid asthma. [2019]

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

Dupilumab progressively improves systemic and cutaneous abnormalities in patients with atopic dermatitis. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Dupilumab efficacy and safety in adults with uncontrolled persistent asthma despite use of medium-to-high-dose inhaled corticosteroids plus a long-acting β2 agonist: a randomised double-blind placebo-controlled pivotal phase 2b dose-ranging trial. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Dupilumab Efficacy in Patients with Uncontrolled Moderate-to-Severe Type 2 Asthma Regardless of Perennial Aeroallergen Sensitization. [2023]

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

Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Dupilumab efficacy and safety in patients with moderate to severe asthma: A systematic review and meta-analysis. [2022]

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

Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Dupilumab in Healthy Adult Subjects. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Human interleukin-4: an immunomodulator with potential therapeutic applications. [2019]

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

Safety and efficacy of eblasakimab, an interleukin 13 receptor α1 monoclonal antibody, in adults with moderate-to-severe atopic dermatitis: A phase 1b, multiple-ascending dose study. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Severe asthma clinical remission after biologic treatment with anti-IL4/IL13: A real-life experience. [2023]

11. England pubmed.ncbi.nlm.nih.gov

An open-label, single-dose bioavailability study of the pharmacokinetics of CAT-354 after subcutaneous and intravenous administration in healthy males. [2021]