A Study to Learn About Study Medicine Called PF-07261271 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 PF-07261271 for the potential treatment of Inflammatory Bowel Disease.

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 INTRAVENOUS AND MULTIPLE SUBCUTANEOUS AND INTRAVENOUS DOSES OF PF-07261271 IN HEALTHY PARTICIPANTS

Conditions
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Healthy

Intervention / Treatment
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* Drug: PF-07261271
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy individuals as determined by medical evaluation Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb). Exclusion Criteria: Clinically significant medical conditions History of HIV infection, hepatitis B, or hepatitis C BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic) Clinically relevant ECG abnormalities Previous study drug administration within 30 days or 5 half-lives of first planned dose History of drug/alcohol abuse or >20 cigarettes/day

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: Cohort 1 active<br>Dose A | Drug: PF-07261271<br>* IV or SC<br>|
| Placebo Comparator: Cohort 1 placebo<br>Dose A | Drug: Placebo<br>* IV or SC<br>|
| Experimental: Cohort 2 active<br>Dose B | Drug: PF-07261271<br>* IV or SC<br>|
| Placebo Comparator: Cohort 2 placebo<br>Dose B | Drug: Placebo<br>* IV or SC<br>|
| Experimental: Cohort 3 active<br>Dose C | Drug: PF-07261271<br>* IV or SC<br>|
| Placebo Comparator: Cohort 3 placebo<br>Dose C | Drug: Placebo<br>* IV or SC<br>|
| Experimental: Cohort 4 active<br>Dose D | Drug: PF-07261271<br>* IV or SC<br>|
| Placebo Comparator: Cohort 4 placebo<br>Dose D | Drug: Placebo<br>* IV or SC<br>|
| Experimental: Cohort 5 active<br>Dose E | Drug: PF-07261271<br>* IV or SC<br>|
| Placebo Comparator: Cohort 5 placebo<br>Dose E | Drug: Placebo<br>* IV or SC<br>|
| Experimental: Cohort 6 active<br>Dose F | Drug: PF-07261271<br>* IV or SC<br>|
| Placebo Comparator: Cohort 6 placebo<br>Dose F | Drug: Placebo<br>* IV or SC<br>|
| Experimental: Cohort 7 active<br>Dose G | Drug: PF-07261271<br>* IV or SC<br>|
| Placebo Comparator: Cohort 7 placebo<br>Dose G | Drug: Placebo<br>* IV or SC<br>|
| Experimental: Cohort 8 active<br>Dose H | Drug: PF-07261271<br>* IV or SC<br>|
| Placebo Comparator: Cohort 8 placebo<br>Dose H | Drug: Placebo<br>* IV or SC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |  | Baseline up to study completion (approximately 471 days) | 
| Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities |  | Baseline up to study completion (approximately 471 days) | 
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs |  | Baseline up to study completion (approximately 471 days) | 
| Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings |  | Baseline up to study completion (approximately 471 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Single Ascending Cohorts | Baseline up to study completion (approximately 451 days) | 
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) | Single Ascending Cohorts | Baseline up to study completion (approximately 451 days) | 
| Area Under the Curve from Time Zero to end of dosing interval (AUCtau) | Multiple Dose Cohorts | Baseline up to study completion (approximately 471 days) | 
| Maximum Observed Plasma Concentration (Cmax) | Single Ascending and Multiple Dose Cohorts | Baseline up to study completion (approximately 471 days) | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | Single Ascending and Multiple Dose Cohorts | Baseline up to study completion (approximately 471 days) | 
| Plasma Decay Half-Life (t1/2) | Single Ascending and Multiple Dose Cohorts | Baseline up to study completion (approximately 471 days) | 
| Incidence of Anti-Drug Antibody (ADA) | The percentage of participants with positive ADA and neutralizing antibodies will be summarized for each treatment arm. | Baseline up to study completion (approximately 471 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy volunteer, Healthy, IBD, Inflammatory bowel disease