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PF-08103402

Phase 1

Healthy Volunteer Study | Small molecule | Respiratory |Pfizer, Inc.|Last Updated: Sep 2, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment139

FDA Designations

No designations recorded

Clinical trial landscape

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 Study
NCT07660731133
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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 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.
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 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 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 D: Cohort 10 (Optional)OTHERPF-08103402 as a single oral dose as tablets on Day 1.
Part C: Cohort 9OTHERPF-08103402 as a single oral dose as tablets on Day 1 of each period

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)

LOWSep 2, 2026NCT07660731Enrollment: 139 → 133
LOWSep 2, 2026NCT07660731Enrollment: 139 → 133
LOWSep 2, 2026NCT07660731Enrollment: 139 → 133
LOWJun 29, 2026NCT07660731Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 29, 2026NCT07660731Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 22, 2026NCT07660731NEW_TRIAL: changed
LOWJun 22, 2026NCT07660731NEW_TRIAL: changed

Frequently asked questions about PF-08103402

What is PF-08103402 used for?

PF-08103402 is an investigational small molecule being studied for use in healthy adults and adults with mild to moderate asthma. It is currently in a Phase 1 clinical trial to evaluate how different amounts of the medicine are tolerated and how it acts in the body.

Who makes PF-08103402?

PF-08103402 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The company is conducting a Phase 1 clinical trial of the drug in the United States.

What phase is PF-08103402 in?

PF-08103402 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to study the drug's tolerability and pharmacokinetics in healthy adults and adults with mild to moderate asthma.

What clinical trials is PF-08103402 in?

PF-08103402 is being studied in one active Phase 1 clinical trial with the identifier NCT07660731. The trial is recruiting 133 participants in the United States and is designed to evaluate how different doses of the drug are tolerated and processed by the body in healthy adults and adults with mild to moderate asthma.

Is PF-08103402 being studied in healthy volunteers?

Yes, PF-08103402 is being studied in healthy volunteers. The Phase 1 clinical trial NCT07660731 is a randomized, double-blind, placebo-controlled study that enrolls healthy adults as well as adults with mild to moderate asthma. The trial is currently recruiting participants aged 18 years and older.