New asthma drug candidate enters first human safety tests
NCT ID NCT07660731
First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 4 times
Summary
This early-stage study tests a new experimental drug, PF-08103402, for the first time in people. It includes healthy adults and adults with mild-to-moderate asthma to check safety, how the drug moves through the body, and whether food affects its absorption. Participants take the drug by mouth as a liquid or tablet, with some groups receiving it daily for up to 14 days. The study also looks at how the drug interacts with another medicine and how it is broken down and eliminated.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PF-08103402
- What this could lead to
- If safe and well-tolerated, this could pave the way for larger studies to see if PF-08103402 helps control asthma symptoms.
- What could go wrong
- This is an early Phase 1 trial focused on safety, not effectiveness. The drug may cause side effects or not work for asthma. Results in healthy people may not apply to those with asthma.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 133 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion criteria (Parts A, B, C, D and F): 1. Are males or females who can no longer have children, 2. Are 18 to 65 years old, 3. Have a body mass index (BMI) of 16 to 32 kilograms per meter squared and a total body weight of more than 50 kilograms (110 pounds). For Part A (Optional group or cohort 3: Japanese participants only): 1. A total body weight of more than 45 kg (100 pounds). 2. Have 4 biological Japanese grandparents who were born in Japan. For Part E only: 1. Adults with a documented doctor's-diagnosis history of asthma for at least 12 months before entering the study. 2. Have a body mass index (BMI) of 16 to 35 kilograms per meter squared and a total body weight of more than 50 kilograms (110 pounds). Key Exclusion criteria 1. Evidence or history of clinically significant medical conditions. 2. History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb). 3. History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. 4. Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study. 5. Any history of parasitic infection requiring treatment within 28 days prior to screening. 6. Positive tuberculosis infection test result. 7. Part C only: Evidence or history of conditions interfering with the ability to taste. 8. Part D only: History of irregular bowel movements. 9. Part E only: Evidence of lung disease(s) other than asthma. 10. Part E only: Asthma exacerbation within 3 months prior to screening. 11. Part F only: History of acute narrow-angle glaucoma, untreated open-angle glaucoma, sleep apnea, respiratory insufficiency, myasthenia gravis or adverse reaction to midazolam or other benzodiazepines.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Pfizer Clinical Research Unit - New Haven
RECRUITINGNew Haven, Connecticut, 06511, United States
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