PF-08103402 for Asthma
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the study medicine PF-08103402 as a suspension or tablet, with varying durations depending on the study part
Follow-up
Participants are monitored for safety and effectiveness after treatment, including a phone call to assess their condition
Optional Extension
Participants may continue to be monitored for additional safety and pharmacokinetic assessments
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
Period 1: Single oral dose of midazolam on Day 1. Period 2: Once daily oral dose of PF-08103402 as tablets from Day 1 through Day 14 and a single oral dose of midazolam on Day 14 after the administration of PF-08103402.
PF-08103402 as a single oral dose as tablets on Day 1.
PF-08103402 as a single oral dose as tablets on Day 1 of each period
PF-08103402 as tablets or matching placebo given once daily oral doses from Day 1 through Day 14.
PF-08103402 as suspensions (Cohorts 1 and 2)/tablets (Optional Cohort 3) or matching placebo as a single oral dose on Day 1 of each period
PF-08103402 as tablets or corresponding placebo as oral doses from Day 1 through Day 14.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
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
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allclinicaltrials.com
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ctv.veeva.com
ctv.veeva.com/study/a-study-to-learn-how-different-amounts-of-the-study-medicine-called-pf-08103402-are-tolerated-and-acA 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 ...
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