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PF-08103402 Study for Healthy Adults and Adults with Asthma

This study is looking at a new medicine called PF-08103402, given as an oral suspension or tablets, to see how safe it is and how it acts in the body. This is the first time PF-08103402 is being given to people. We are looking for healthy adults or adults with mild-to-moderate asthma, aged 18 to 65, who can no longer have children. The study will also use a placebo (an inactive substance) and Midazolam (an oral syrup). We will measure how many participants experience side effects or serious adverse events, and any significant changes in lab test results. The study aims to enroll 139 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. The study is testing different amounts of PF-08103402 or a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for side effects and serious adverse events for up to 36 or 50 days, depending on the study part. Lab changes will be monitored for up to 7 or 17 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07660731

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

Recruiting
PHASE1Ages 18–65InterventionalBasic science
Pfizer
~139 participants
Updated 2026-06-29 on ClinicalTrials.gov
What's tested:PF-08103402PlaceboMidazolam

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Measured over Parts A: Up to Day 36; Part B and E: Up to Day 50
+9 more outcomes measured

Conditions

Healthy Volunteer Study
Healthy Adults
Healthy Participants
Asthma

Explore related trials

AsthmaHealthy Volunteers

Where it's being run

1 sites across 1 states
Connecticut1

Study leadership

  • Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer

Who to contact

Pfizer CT.gov Call Center
[email protected]
1-800-718-1021
Email the study team

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What this trial measures

  • 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 AbnormalitiesParts 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 SignsParts 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) FindingsParts 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 statePre-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 statePre-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 administeredPre-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 AUClastPre-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)