A Study to Learn How Different Amounts of the Study Medicine Called PF-07941944 Are Tolerated in the Body of Healthy Adults.

NCT06920498 | Completed Phase 1 FDA Drug

• 2 other identifiers: C59610012024-515421-28-00
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial is to learn about the safety and tolerability of the study medicine (called PF-07941944) in healthy participants. This study is seeking participants who:

• Are male or female between the ages of 18 and 60
• Are generally healthy The investigators will compare the experiences of people receiving the study medicine to those of the people who do not. This will help the investigators determine if the study medicine is safe and well tolerated. Participants enrolled in Part 1 will take part in this study for approximately 4 months. Participants enrolled in Part 2 or Part 3 will take part in this study for approximately 2.5 months. Study visits will take place at the study clinic. The study team will also call participants once at the end of the study over the phone.

Conditions

Healthy Participants

Keywords

Respiratory syncytial virus (RSV)

Outcome Measures

Primary Outcomes (7)

• Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)

  Part 1 and Part 2

  Baseline through end of study, approximately 16 weeks

• Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities

  Part 1 and Part 2

  Baseline through end of study, approximately 16 weeks

• Number of Participants With Clinically Significant Change From Baseline in Vital Signs

  Part 1 and Part 2

  Baseline through end of study, approximately 16 weeks

• Number of Participants With Change From Baseline in Electrocardiogram (ECG) Findings

  Part 1 and Part 2

  Baseline through end of study, approximately 16 weeks

• Maximum Observed Plasma Concentration (Cmax)

  Part 3

  Baseline through end of study, approximately 16 weeks

• Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)

  Part 3 - if data permit

  Baseline through end of study, approximately 16 weeks

• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

  Part 3 - If AUCinf not collected

  Baseline through end of study, approximately 16 weeks

Secondary Outcomes (10)

• Cmax

  Baseline through end of study, approximately 16 weeks

• Time to Reach Maximum Observed Plasma Concentration (Tmax)

  Baseline through end of study, approximately 16 weeks

• AUClast

  Baseline through end of study, approximately 16 weeks

• AUCinf

  Baseline through end of study, approximately 16 weeks

• Plasma Decay Half-Life (t1/2)

  Baseline through end of study, approximately 16 weeks

Study Arms (3)

Part 1

EXPERIMENTAL

Single ascending dose of PF-07941944 or placebo in healthy adult participants

Drug: PF-07941944; Drug: Placebo

Part 2

EXPERIMENTAL

Multiple doses of PF-07941944 or placebo in healthy adult participants

Drug: PF-07941944; Drug: Placebo

Part 3 (Optional)

EXPERIMENTAL

Period 1, single dose of Midazolam. Period 2, multiple doses of PF-07941944 + Midazolam

Drug: PF-07941944; Drug: Midazolam

Interventions

PF-07941944 DRUG

Oral formulation

Part 1; Part 2; Part 3 (Optional)

Placebo DRUG

Oral formulation

Part 1; Part 2

Midazolam DRUG

Oral formulation

Part 3 (Optional)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants who are overtly healthy as determined by medical evaluation
• Body mass index (BMI) of 17.5 to 30.5 kg/m2

You may not qualify if:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease
• Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions that may increase the risk of study participation
• Use of prescription or nonprescription drugs and dietary and herbal supplements within 28 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.
• Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).
• History of alcohol abuse or repeated binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
• Part 3 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. History of hypersensitivity reaction to midazolam, or any of the formulation components.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit - Brussels

Brussels, Bruxelles-capitale, Région de, B-1070, Belgium

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: April 9, 2025
• Study Start: December 3, 2024
• Primary Completion: June 19, 2025
• Study Completion: June 19, 2025
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)