Clinical trial
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
Name
C4531001
Description
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.
Trial arms
Trial start
2022-06-09
Estimated PCD
2024-04-22
Trial end
2024-04-22
Status
Active (not recruiting)
Phase
Early phase I
Treatment
PF-07275315
Active drug
Arms:
Active
Other names:
No other name
Placebo
Placebo
Arms:
Placebo
Other names:
No other name
Size
65
Primary endpoint
Number of participants with Adverse Events (AEs)
Baseline through study completion, approximately 561 days
Number of participants with clinically meaningful 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
Baseline through study completion, approximately 561 days
Number of participants with Serious AEs (SAEs)
Baseline through study completion, approximately 561 days
Number of participants with clinically meaningful change from baseline in ECG parameters
Baseline through study completion, approximately 561 days
Eligibility 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 65, 'type': 'ACTUAL'}}
Updated at
2024-04-04
1 organization
2 products
1 indication
Organization
PfizerProduct
PF-07275315Indication
Healthy Control ParticipantsProduct
Placebo