A Study to Learn How the Study Medicine Called PF-07275315 Works in Healthy People

Study Overview
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Brief Summary
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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
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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.

Official Title
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A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR OPEN, PLACEBO-CONTROLLED, DOSE ESCALATING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SINGLE AND MULTIPLE INTRAVENOUS AND SUBCUTANEOUS DOSES OF PF-07275315 IN HEALTHY PARTICIPANTS

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: PF-07275315
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>PF-07275315 | Drug: PF-07275315<br>* Active drug<br>* Other names: No other name;|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo<br>* Other names: No other name;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Adverse Events (AEs) | Incidence and severity of AEs | Baseline through study completion, approximately 561 days | 
| Number of participants with clinically meaningful change from baseline in laboratory Tests Results | Number of Participants With Change From Baseline in Laboratory Tests Results | Baseline through study completion, approximately 561 days | 
| Number of participants with clinically meaningful change from baseline in vital signs | Number of participants with change from baseline in vital signs | Baseline through study completion, approximately 561 days | 
| Number of participants with Serious AEs (SAEs) | Incidence and severity of SAEs | Baseline through study completion, approximately 561 days | 
| Number of participants with clinically meaningful change from baseline in ECG parameters | number of participants with change from baseline in ECG parameters | Baseline through study completion, approximately 561 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Concentration (Cmax) | Cmax will be observed directly from data. | 1- 561 Days | 
| Time to Maximum Plasma Concentration (Tmax) of PF-07275315 | Tmax will be observed directly from data. | 1 - 561 Days | 
| Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) of PF-07275315 | Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) | 1 - 561 Days | 
| Incidence of the development of Antidrug antibodies (ADA) against PF-07275315 | To evaluate the immunogenicity profile of PF-07275315 in healthy adults. | 1 - 561 Days | 
| Half-life of PF-07275315 | terminal elimination half-life will be measured | 1-561 days | 
| Area under the curve (AUC) of PF-07275315 serum concentration time-profile from time zero extrapolated to infinite time | AUCinf | 1-561 days | 
| AUC of PF-07275315 serum concentration time-profile over the dosing interval of 2 weeks or 336 hours | AUC336 | 1-561 days | 
| Incidence of the development of neutralizing antibodies (NAb) against PF-07275315 | To evaluate the immunogenicity profile of PF-07275315 in healthy adults. | 1-561 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PF-07275315