A Study to Learn How the Study Medicine Called PF-07275315 Works in Healthy People
Part of paid clinical trials in Lake Forest, California.
- Sponsor
- Pfizer
- Study ID
- NCT05411588
- Phase
- PHASE1
- Status
- Completed
Conditions
- Healthy Volunteers
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Accepted
Interventions
- PF-07275315 — DRUGActive drug
- Placebo — DRUGPlacebo
Study Details
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07275315) in healthy participants. This study is seeking participants who: * Are healthy as determined by medical evaluation. * Are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. * Have a body mass index (BMI) of 17.5 to 32 kilogram per meter square - a total body weight of more than 50 kilograms (110 pounds) Participants will be divided randomly into 8 different groups. All participants will receive either one PF-07275315 or a harmless treatment that has no medical effect (placebo) intravenous (IV) infusion (given directly into a vein). Participants will take part in this study for up to 541 days. During this time, eligible participants will receive single increasing amounts of PF-07275315 or placebo. Increase will only occur if the sponsor agrees that the next dose is likely to have acceptable safety and tolerability. The follow-up visit will take place 271 days after first treatment.
Key Dates
- Start date
- Jun 9, 2022
- Status verified
- May 2025
- Primary completion
- May 13, 2024
- Completion
- May 13, 2024
Study Design
- Enrollment
- 65 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: ActivePF-07275315
- Placebo Comparator: PlaceboPlacebo
Primary Outcome Measure
Number of participants with Adverse Events (AEs) [ Time Frame: Baseline through study completion, approximately 561 days ]
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Orange County Research Center | Lake Forest | California | 92630 | - |
| Orange County Research Center | Tustin | California | 92780 | - |
| New Haven Clinical Research Unit | New Haven | Connecticut | 06511 | - |
| Qps-Mra, Llc | South Miami | Florida | 33143 | - |
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