Clinical trial NCT06920498: A Study to Learn How Different Amounts of the Study Medicine Called PF-07941944 Are Tolerated in the Body of Healthy Adults.
Official title: A Multipart Phase 1 Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled Study With Single and Multiple Dose Escalation to Evaluate the Safety, Tolerability, and Pharmacokinetics of PF-07941944 in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Respiratory syncytial virus (RSV)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2025-04-09
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

* Participants who are overtly healthy as determined by medical evaluation
* Body mass index (BMI) of 17.5 to 30.5 kg/m2
* For inclusion of Japanese participants: participants who have 4 Japanese biologic grandparents who were born in Japan.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
timeFrame: Baseline through end of study, approximately 16 weeks
measure: Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
timeFrame: Baseline through end of study, approximately 16 weeks
measure: Number of Participants With Clinically Significant Change From Baseline in Vital Signs
timeFrame: Baseline through end of study, approximately 16 weeks
measure: Number of Participants With Change From Baseline in Electrocardiogram (ECG) Findings
timeFrame: Baseline through end of study, approximately 16 weeks
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Baseline through end of study, approximately 16 weeks
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
timeFrame: Baseline through end of study, approximately 16 weeks
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: Baseline through end of study, approximately 16 weeks
Secondary outcomes:
measure: Cmax
timeFrame: Baseline through end of study, approximately 16 weeks
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: Baseline through end of study, approximately 16 weeks
measure: AUClast
timeFrame: Baseline through end of study, approximately 16 weeks
measure: AUCinf
timeFrame: Baseline through end of study, approximately 16 weeks
measure: Plasma Decay Half-Life (t1/2)
timeFrame: Baseline through end of study, approximately 16 weeks
measure: Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
timeFrame: Baseline through end of study, approximately 16 weeks
measure: Number of Participants With Treatment Emergent Treatment-Related AEs
timeFrame: Baseline through end of study, approximately 16 weeks
measure: Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
timeFrame: Baseline through end of study, approximately 16 weeks
measure: Number of Participants With Clinically Significant Change From Baseline in Vital Signs
timeFrame: Baseline through end of study, approximately 16 weeks
measure: Number of Participants With Change From Baseline in ECG Findings
timeFrame: Baseline through end of study, approximately 16 weeks
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Pfizer Clinical Research Unit - Brussels
state: Bruxelles-capitale, Région DE
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: