Healthy Volunteers
Conditions
Keywords
PF-07275315
Brief summary
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.
Detailed description
This is an first-in-human within-cohort randomized, participant- and investigator-blind, sponsor-open, placebo-controlled study of the safety, tolerability, PK, and PD following single and multiple escalating doses of PF-07275315 that will be conducted in healthy adults.
Interventions
DRUGPF-07275315
Active drug
DRUGPlacebo
Placebo
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
This study is seeking participants who: * Are overtly 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 kg/m2; and a total body weight \>50 kg (110 lb). This study is not seeking participants who have: * Evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis (TB) as defined by both of the following * History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; * Any of the following acute or chronic infections or infection history * Any malignancies or have a history of malignancies with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ. * Have undergone significant trauma or major surgery within 1 month of the first dose of study drug.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Adverse Events (AEs) | Baseline through study completion, approximately 561 days | Incidence and severity of AEs |
| Number of participants with clinically meaningful change from baseline in laboratory Tests Results | Baseline through study completion, approximately 561 days | Number of Participants With Change From Baseline in Laboratory Tests Results |
| Number of participants with clinically meaningful change from baseline in vital signs | Baseline through study completion, approximately 561 days | Number of participants with change from baseline in vital signs |
| Number of participants with Serious AEs (SAEs) | Baseline through study completion, approximately 561 days | Incidence and severity of SAEs |
| Number of participants with clinically meaningful change from baseline in ECG parameters | Baseline through study completion, approximately 561 days | number of participants with change from baseline in ECG parameters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the curve (AUC) of PF-07275315 serum concentration time-profile from time zero extrapolated to infinite time | 1-561 days | AUCinf |
| Maximum Plasma Concentration (Cmax) | 1- 561 Days | Cmax will be observed directly from data. |
| Incidence of the development of neutralizing antibodies (NAb) against PF-07275315 | 1-561 days | To evaluate the immunogenicity profile of PF-07275315 in healthy adults. |
| AUC of PF-07275315 serum concentration time-profile over the dosing interval of 2 weeks or 336 hours | 1-561 days | AUC336 |
| Time to Maximum Plasma Concentration (Tmax) of PF-07275315 | 1 - 561 Days | Tmax will be observed directly from data. |
| Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) of PF-07275315 | 1 - 561 Days | Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) |
| Incidence of the development of Antidrug antibodies (ADA) against PF-07275315 | 1 - 561 Days | To evaluate the immunogenicity profile of PF-07275315 in healthy adults. |
| Half-life of PF-07275315 | 1-561 days | terminal elimination half-life will be measured |
Countries
Belgium, United States
Outcome results
None listed