Testing how well PF-07941944 is tolerated in healthy adults
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
This study is testing how well a new medicine called PF-07941944 is tolerated by healthy adults to see if it is safe for use.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 1 site (Brussels, Bruxelles-capitale, Région DE) |
| Trial ID | NCT06920498 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and tolerability of the investigational medicine PF-07941944 in healthy adult participants. The study will involve administering different amounts of the medication and comparing the experiences of those receiving the drug to those receiving a placebo. Participants will be monitored over a period of approximately 4 months for Part 1 and 2.5 months for Parts 2 and 3, with regular study visits and follow-up calls to assess their health and any side effects.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy males and females aged 18 to 60 with a BMI between 17.5 and 30.5 kg/m2.
Not a fit: Patients with significant medical or psychiatric conditions, or those taking certain medications, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable information on the safety profile of PF-07941944, potentially leading to new treatments for respiratory syncytial virus (RSV).
How similar studies have performed: While this study focuses on a specific investigational drug, similar studies assessing the safety of new medications in healthy participants have shown success in the past.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Brussels, Bruxelles-capitale, Région DE
- Pfizer Clinical Research Unit - Brussels — Brussels, Bruxelles-capitale, Région DE, Belgium (Recruiting)
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.