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PF-08103402 for Asthma

Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Pfizer

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medicine, PF-08103402, as a potential asthma treatment to determine its safety for people, especially those with mild-to-moderate asthma. The trial consists of different parts: some healthy adults will receive the medicine to assess how the body handles it and whether food affects its absorption. For adults with asthma, the focus is on how the body processes the medicine. Participants must have had asthma for at least a year and not experienced any severe asthma attacks in the past three months. This opportunity allows eligible individuals to contribute to the development of new asthma treatments. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the chance 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 if you need to stop taking your current medications. It's best to discuss this with the study team to understand any specific requirements.

Is there any evidence suggesting that PF-08103402 is likely to be safe for humans?

Research has shown that the safety of the new study medicine, PF-08103402, is still under evaluation. This trial marks the first time the medicine is tested in humans, so limited safety information is available. However, some data suggest that participants might experience side effects such as nervousness, headaches, and an increased heartbeat.

In these early trial stages, the primary goal is to assess how well participants tolerate the medicine. Researchers are closely monitoring for any side effects. As the process is still in its initial phase, they continue to gather safety information, and some side effects may occur. Participants in the trial can expect regular check-ups to monitor health and any reactions to the medicine.12345

Why do researchers think this study treatment might be promising?

PF-08103402 is unique because it offers a new approach to treating asthma by targeting pathways that current treatments might not address. Most asthma treatments, like inhaled corticosteroids and bronchodilators, focus on reducing inflammation or relaxing airway muscles. However, PF-08103402 is being tested as an oral medication, which could provide a convenient alternative to inhalers. Researchers are excited about its potential to offer a different mechanism of action, possibly improving asthma management for patients who struggle with existing options.

What evidence suggests that PF-08103402 might be an effective treatment for asthma?

Research has shown that PF-08103402 is a new treatment under study for asthma. The trial will test PF-08103402 in various treatment arms, including single and multiple doses, to evaluate its effectiveness and safety. Since this medicine is being tested in people for the first time, there is limited information on its efficacy. The treatment aims to alleviate asthma symptoms by targeting specific processes in the body. Early studies in labs and with animals suggest it might reduce swelling and improve breathing. More research is needed to determine its effectiveness for people with asthma.36789

Who Is on the Research Team?

PC

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-65 who can't have children, with a BMI of 16–32 (or up to 35 for those with asthma) and weighing over 50 kg. Some groups are only for Japanese participants or people with mild-to-moderate asthma diagnosed at least a year ago.

Inclusion Criteria

Part A: Have 4 biological Japanese grandparents born in Japan
I am not able to have children anymore.
Part E: BMI of 16 to 35 kg/m² and total body weight over 50 kg (110 pounds)
See 4 more

Exclusion Criteria

I have not needed treatment for a parasite infection in the last 28 days.
Positive tuberculosis infection test
Part C: Evidence or history of conditions interfering with ability to taste
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the study medicine PF-08103402 as a suspension or tablet, with varying durations depending on the study part

9-16 weeks
2 study visits and up to 28 overnight stays

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a phone call to assess their condition

2 weeks
1 phone call

Optional Extension

Participants may continue to be monitored for additional safety and pharmacokinetic assessments

Varies

What Are the Treatments Tested in This Trial?

Interventions

  • PF-08103402

Trial Overview

The study tests different doses of PF-08103402 (a new medicine) taken by mouth, compared to placebo and sometimes midazolam. It looks at safety, how the body handles the drug in healthy adults and those with mild-to-moderate asthma, and possible interactions between medicines.

How Is the Trial Designed?

6

Treatment groups

Experimental Treatment

Placebo Group

Group I: Part F: Cohort 13 (Optional)Experimental Treatment3 Interventions
Group II: Part D: Cohort 10 (Optional)Experimental Treatment2 Interventions
Group III: Part C: Cohort 9Experimental Treatment2 Interventions
Group IV: Part B: Cohorts 4, 5, 6, 7, and Optional Cohort 8Placebo Group2 Interventions
Group V: Part A: Cohorts 1, 2 and Optional Cohort 3Placebo Group2 Interventions
Group VI: Part E: Cohorts 11 (Optional) and 12 (Optional)Placebo Group2 Interventions

Find a Clinic Near You

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 profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/32562878/

Clinical and Economic Outcomes in Patients with ...

HEDIS attainment was associated with significantly improved asthma outcomes and lower asthma-specific costs.

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This real-world study showed that the effectiveness of asthma medications varied according to drug type, active ingredient, combination, and period of use.

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Assessment of asthma control and asthma exacerbations ...

In this review, we summarize the findings from TENOR in relation to asthma control and asthma exacerbations in patients with severe or difficult-to-treat ...

NCT07660731 | A Study to Learn How Different Amounts of ...

The purpose of this study is to learn about the safety of a new study medicine called PF-08103402 in healthy adults (do not have disease) ...

A Study to Learn How Different Amounts of the Study Medicine ...

The purpose of this study is to learn about the safety of a new study medicine called PF-08103402 in healthy adults (do not have disease) ...

MATERIAL SAFETY DATA SHEET

Adverse effects associated with therapeutic use include nervousness, headache, increased heart rate (tachycardia). EU Classification. EU ...

9.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/9156480/

The impact of the COSHH regulations on workers ...

The aim of the study was to evaluate the impact of the Regulations on employees with occupational asthma. One hundred consecutive patients attending an ...