Recruiting

A Study to Learn How Different Amounts of the Study Medicine Called PF-08103402 Are Tolerated and Act in the Body in Healthy Adults or Adults With Mild To-moderate Asthma

ClinicalTrials.gov IDNCT07660731

PhasePHASE1

Enrollment133

SponsorPfizer

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Healthy Volunteer Study, Healthy Adults, Healthy Participants, Asthma

About this study

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) and or in adults with mild-to-moderate asthma. This is the first time the study medicine is being given to people. For Parts A, B, C, D and F, the study is seeking participants who: * Are healthy (do not have disease) males or females who can no longer have children, * Are 18 to 65 years old, * Have a body mass index (BMI) of 16 to 32 kilograms per meter squared and a body weight of more than 50 kilograms (110 pounds). Body mass index is a way to measure body fat by using a person's height and weight For Part A (optional group or cohort 3: Japanese participants only): * A body weight of more than 45 kilograms (100 pounds). * Have 4 biological Japanese grandparents who were born in Japan. For Part E only: * Adults with a documented history of asthma (confirmed by a doctor) for at least 12 months before entering the study. * 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). The study has six parts: Part A, Part B, Part C, Part D, Part E and Part F. The study medicine will be taken as a suspension or tablet by mouth 1 time a day (except in Parts B and E where it will be taken 1 time a day for 14 days) at the study clinic. The study will help understand: * how the body processes the study medicine in healthy participants (Parts A and B), * how much of the study medicine gets into the bloodstream and if food affects the amount of study medicine in the blood in healthy participants (Part C), * how the study medicine is broken down and leaves the body in healthy participants (Optional Part D), * how the study medicine is processed in adults with mild-to-moderate asthma (Optional Part E), * if taking the study medicine together with another medicine affects how each medicine is processed by the body in healthy participants (Optional Part F). Participants will take part in the study for about 10 weeks (Parts A and F), 12 weeks (Part B), 9 weeks (Parts C and D), and 16 weeks (Part E). During this time, they will have 2 study visits at the study clinic and up to 28 overnight stays (Part A), 18 overnight stays (Parts B and E), 10 overnight stays (Part C), 11 overnight stays (Part D), and 16 overnight stays (Part F). The study team will also call participants 1 time over the phone at the end of the study to assess how they are doing. Study…

Interventions

Drug: PF-08103402 — Oral suspension (Parts A to F); Tablets (Parts C and F only)
Drug: Placebo — Oral suspension (Parts A, B and E).
Drug: Midazolam — Oral syrup

Primary outcomes

Number of Participants with Treatment Emergent Adverse Events (TEAEs) (Parts A: Up to Day 36; Part B and E: Up to Day 50)
Number of Participants with Serious Adverse Events (SAEs) (Parts A: Up to Day 36; Part B and E: Up to Day 50)
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities (Parts A: Change From Baseline to Day 7; Part B and E: Change From Baseline to Day 17)
Number of Participants With Clinically Significant Change From Baseline in Vital Signs (Parts A: Change From Baseline to Day 7; Part B and E: Change From Baseline to Day 17)
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings (Parts A: Change From Baseline to Day 7; Part B and E: Change From Baseline to Day 17)
Area under the curve from time zero to extrapolated infinite time (AUCinf) if data permit, otherwise (AUClast) in the fasted state (Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1)
Maximum observed plasma concentration (Cmax) in the fasted state (Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1)
Total recovery of drug-related material in urine and feces separately, and both routes combined, expressed as a percent of total dose administered (Pre-dose (Hour 0) and at 1.5, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1 and at 24 hours post-dose (Day 2))

Eligibility information

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.

Study locations

Pfizer Clinical Research Unit - New Haven, New Haven, Connecticut 06511 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.