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PF-08103402

Phase 1

Asthma | Small molecule | Respiratory |Pfizer, Inc.|Trials Updated: Oct 13, 2026

PF-08103402 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jun 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment133

FDA Designations

No designations recorded

PF-08103402 clinical trials

PF-08103402 · 1 trial · 4 indications

Phase 1 1
NCT07660731A 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 AsthmaHealthy Volunteer Study
RECRUITING133 Analytics
PHASE1RECRUITING
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
Healthy Volunteer StudyUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Parts A: Up to Day 36; Part B and E: Up to Day 50

Part A: Cohorts 1, 2 and Cohort 3 (optional). Part B: Cohorts 4, 5, 6, and 7 and Cohort 8 (optional). Part E: Cohorts 11 (optional) and 12 (optional)

Number of Participants with Serious Adverse Events (SAEs)
Parts A: Up to Day 36; Part B and E: Up to Day 50

Part A: Cohorts 1, 2 and Cohort 3 (optional). Part B: Cohorts 4, 5, 6, and 7 and Cohort 8 (optional). Part E: Cohorts 11 (optional) and 12 (optional)

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

Part A: Cohorts 1, 2 and Cohort 3 (optional). Part B: Cohorts 4, 5, 6, and 7 and Cohort 8 (optional). Part E: Cohorts 11 (optional) and 12 (optional)

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

Part A: Cohorts 1, 2 and Cohort 3 (optional). Part B: Cohorts 4, 5, 6, and 7 and Cohort 8 (optional). Part E: Cohorts 11 (optional) and 12 (optional).

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

Part A: Cohorts 1, 2 and Cohort 3 (optional). Part B: Cohorts 4, 5, 6, and 7 and Cohort 8 (optional). Part E: Cohorts 11 (optional) and 12 (optional).

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

Part C: Cohort 9

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

Part C: Cohort 9

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)

Part D: Cohort 10 (optional)

Maximum observed plasma concentration (Cmax)
Pre-dose (Hour 0) and at 0.5, 1, 2, 4, 6, 8, 12 hours post-dose on Day 1 and at 24 hours post-dose (Day 2)

Part F: Cohort 13 (optional)

Area under the curve from time zero to extrapolated infinite time (AUCinf) if data permit, otherwise AUClast
Pre-dose (Hour 0) and at 0.5, 1, 2, 4, 6, 8, 12 hours post-dose on Day 1 and at 24 hours post-dose (Day 2)

Part F: Cohort 13 (optional)

Secondary Endpoints

Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1 and at 24 and 36 hours post-dose (Day 2)
Maximum observed plasma concentration (Cmax)
Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1 and at 24 and 36 hours post-dose (Day 2)
Time of Maximum observed plasma concentration (Tmax)
Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1 and at 24 and 36 hours post-dose (Day 2)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Part A: Cohorts 1, 2 and Optional Cohort 3PLACEBO_COMPARATORPF-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
Part B: Cohorts 4, 5, 6, 7, and Optional Cohort 8PLACEBO_COMPARATORPF-08103402 as tablets or matching placebo given once daily oral doses from Day 1 through Day 14.
Part C: Cohort 9OTHERPF-08103402 as a single oral dose as tablets on Day 1 of each period
Part D: Cohort 10 (Optional)OTHERPF-08103402 as a single oral dose as tablets on Day 1.
Part E: Cohorts 11 (Optional) and 12 (Optional)PLACEBO_COMPARATORPF-08103402 as tablets or corresponding placebo as oral doses from Day 1 through Day 14.
Part F: Cohort 13 (Optional)OTHERPeriod 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.

Interventions

NameTypeDescription
PF-08103402DRUGOral suspension (Parts A to F); Tablets (Parts C and F only)
PlaceboDRUGOral suspension (Parts A, B and E).
MidazolamDRUGOral syrup
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:United States
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Recent Changes (Last 90 Days)

LOWOct 13, 2026NCT07660731lastUpdatePostDate: changed
LOWOct 13, 2026NCT07660731lastUpdatePostDate: changed
LOWSep 2, 2026NCT07660731Enrollment: 139 → 133
LOWSep 2, 2026NCT07660731Enrollment: 139 → 133
LOWSep 2, 2026NCT07660731Enrollment: 139 → 133

Frequently asked questions about PF-08103402

What is PF-08103402?

PF-08103402 is an investigational small molecule developed by Pfizer, Inc. for the treatment of asthma. It is currently in Phase 1 clinical development and has not been approved by the FDA. Pfizer is evaluating the drug in a single recruiting trial that includes healthy adults and adults with mild to moderate asthma.

What is PF-08103402 used for in asthma?

PF-08103402 is being studied as a potential treatment for asthma, a respiratory condition. The Phase 1 trial enrolls adults with mild to moderate asthma as well as healthy participants. Because the drug is still in early clinical development, its use in asthma remains investigational and it is not available as a prescribed therapy.

Who makes PF-08103402?

Pfizer, Inc. is developing PF-08103402. The company trades on the New York Stock Exchange under the ticker PFE. Pfizer is the sponsor of the Phase 1 study evaluating the drug in healthy adults and adults with mild to moderate asthma.

What phase is PF-08103402 in?

PF-08103402 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA for any indication. The ongoing Phase 1 trial is designed to assess how different amounts of the study medicine are tolerated and how it acts in the body.

What clinical trials is PF-08103402 in?

PF-08103402 is being evaluated in one clinical trial, NCT07660731, titled 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. The trial is recruiting, is placebo controlled, randomized, and double blind, and plans to enroll 133 participants in the United States.