Phase 1 Completed N=35 Randomized Double-blind Treatment

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

Healthy

Source: ClinicalTrials.gov NCT05536440 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2025

Primary outcomePrimary: Number of Participants With Treatment Emergent Adverse Events (TEAEs): SAD Cohort — 4; 1; 1; 3 Participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs): SAD Cohort	4; 1; 1; 3; 2; 0	—
PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs): MD Cohort	2; 5	—
PRIMARY Number of Participants With Serious Adverse Events (SAEs): SAD Cohort	0; 0; 0; 0; 0; 0	—
PRIMARY Number of Participants With Serious Adverse Events (SAEs): MD Cohort	0; 0	—
PRIMARY Number of Participants With Clinically Significant Changes in Vital Signs Abnormalities: SAD Cohort	0; 0; 0; 0; 0; 0	—
PRIMARY Number of Participants With Clinically Significant Changes in Vital Signs Abnormalities: MD Cohort	0; 0	—
PRIMARY Number of Participants With Clinically Significant Changes in Laboratory Abnormalities: SAD Cohort	0; 0; 0; 0; 0; 0	—
PRIMARY Number of Participants With Clinically Significant Changes in Laboratory Abnormalities: MD Cohort	0; 0	—
PRIMARY Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Abnormalities: SAD Cohort	0; 0; 0; 0; 0; 0	—
PRIMARY Number of Participants With Clinically Significant Changes in ECG Abnormalities: MD Cohort	0; 0	—
SECONDARY Area Under the Concentration Versus Time Curve From Time Zero to the Last Quantifiable Time Point (AUClast) of PF-07261271: SAD Cohort	NA; NA; 65600000; 324100000; 345000000	—
SECONDARY Area Under the Serum Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-07261271: SAD Cohort	NA; NA; 61010000; 332600000; 368100000	—
SECONDARY Maximum Plasma Concentration (Cmax) of PF-07261271: SAD Cohort	NA; NA; 143300; 372800; 313900	—
SECONDARY Time to Maximum Plasma Concentration (Tmax) of PF-07261271: SAD Cohort	NA; NA; 2.12; 3.13; 5.26	—
SECONDARY Terminal Elimination Half-life (t1/2) of PF-07261271: SAD Cohort	NA; NA; 330.7; 1533; 1529	—
SECONDARY Area Under the Concentration Time Profile From Time Zero to Time Tau (τ), the Dosing Interval (AUCtau) of PF-07261271: MD Cohort	17600000; 27900000	—
SECONDARY Cmax of PF-07261271: MD Cohort	34120; 49600	—
SECONDARY Tmax of PF-07261271: MD Cohort	253; 170	—
SECONDARY Terminal Elimination Half-life (t1/2) of PF-07261271: MD Cohort	1150	—
SECONDARY Number of Participants With Anti-drug Antibodies (ADA) Against PF-07261271: SAD Cohort	2; 2; 4; 6; 4	—
SECONDARY Number of Participants With ADA Against PF-07261271: MD Cohort	6	—
SECONDARY Number of Participants With Neutralizing Antibodies (NAb) Against PF-07261271: SAD Cohort	2; 2; 4; 5; 2	—
SECONDARY Number of Participants With NAb Against PF-07261271: MD Cohort	5	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05536440). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.