A Study to Learn About Study Medicine Called PF-07261271 in Healthy People

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05536440
• Other study ID #: C4631001
• Status: Completed
• Phase: Phase 1
• Start date: October 17, 2022
• Est. completion date: February 29, 2024

Study information

• Verified date: March 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: February 29, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PF-07261271
IV or SC
• Placebo
IV or SC

Locations

Country	Name	City	State
United States	Clinilabs	Eatontown	New Jersey
United States	Orange County Research Center	Lake Forest	California
United States	ICON	Salt Lake City	Utah
United States	Orange County Research Center	Tustin	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)		Baseline up to study completion (approximately 471 days)
Primary	Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities		Baseline up to study completion (approximately 471 days)
Primary	Number of Participants With Clinically Significant Change From Baseline in Vital Signs		Baseline up to study completion (approximately 471 days)
Primary	Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings		Baseline up to study completion (approximately 471 days)
Secondary	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	Single Ascending Cohorts	Baseline up to study completion (approximately 451 days)
Secondary	Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)	Single Ascending Cohorts	Baseline up to study completion (approximately 451 days)
Secondary	Area Under the Curve from Time Zero to end of dosing interval (AUCtau)	Multiple Dose Cohorts	Baseline up to study completion (approximately 471 days)
Secondary	Maximum Observed Plasma Concentration (Cmax)	Single Ascending and Multiple Dose Cohorts	Baseline up to study completion (approximately 471 days)
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax)	Single Ascending and Multiple Dose Cohorts	Baseline up to study completion (approximately 471 days)
Secondary	Plasma Decay Half-Life (t1/2)	Single Ascending and Multiple Dose Cohorts	Baseline up to study completion (approximately 471 days)
Secondary	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)

External Links

•   To obtain contact information for a study center near you, click here.