Pfizer medicine PF-08103402: how different doses are tolerated in healthy adults and adults with mild-to-moderate asthma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1, interventional study investigates safety, tolerability, and pharmacokinetics of PF-08103402 across multiple dosing cohorts in healthy adults and adults with asthma. Participants include adults aged 18–65 (with BMI 16–32, weight >50 kg) who are healthy or have mild-to-moderate asthma, and optional Japanese cohorts with specific ancestry criteria. The study uses PF-08103402, placebo, and midazolam as comparators to characterize metabolism, excretion, and potential drug–drug interactions. Key exclusions include significant medical conditions or certain infectious diseases. The trial is sponsored by Pfizer and conducted at Pfizer Clinical Research Units in New Haven, CT and Brussels, Belgium.

Why it matters

Who can join: the full rules

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.

Where it's running

• Pfizer Clinical Research Unit - New Haven
  New Haven, Connecticut, United States Recruiting
• Pfizer Clinical Research Unit - Brussels
  Brussels, Belgium Recruiting

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.