Clinical trial NCT05536440: A Study to Learn About Study Medicine Called PF-07261271 in Healthy People
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy volunteer
Healthy
IBD
Inflammatory bowel disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-09-10
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs): SAD Cohort
timeFrame: From start of study intervention (Day 1) up to end of study, approximately up to 15 months
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs): MD Cohort
timeFrame: From start of study intervention (Day 1) up to end of study, approximately of 15.5 months
measure: Number of Participants With Serious Adverse Events (SAEs): SAD Cohort
timeFrame: From start of study intervention (Day 1) up to end of study, approximately up to 15 months
measure: Number of Participants With Serious Adverse Events (SAEs): MD Cohort
timeFrame: From start of study intervention (Day 1) up to end of study, approximately of 15.5 months
measure: Number of Participants With Clinically Significant Changes in Vital Signs Abnormalities: SAD Cohort
timeFrame: From start of study intervention (Day 1) up to end of study, approximately up to 15 months
measure: Number of Participants With Clinically Significant Changes in Vital Signs Abnormalities: MD Cohort
timeFrame: From start of study intervention (Day 1) up to end of study, approximately of 15.5 months
measure: Number of Participants With Clinically Significant Changes in Laboratory Abnormalities: SAD Cohort
timeFrame: From start of study intervention (Day 1) up to end of study, approximately up to 15 months
measure: Number of Participants With Clinically Significant Changes in Laboratory Abnormalities: MD Cohort
timeFrame: From start of study intervention (Day 1) up to end of study, approximately of 15.5 months
measure: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Abnormalities: SAD Cohort
timeFrame: From start of study intervention (Day 1) up to end of study, approximately up to 15 months
measure: Number of Participants With Clinically Significant Changes in ECG Abnormalities: MD Cohort
timeFrame: From start of study intervention (Day 1) up to end of study, approximately of 15.5 months
Secondary outcomes:
measure: Area Under the Concentration Versus Time Curve From Time Zero to the Last Quantifiable Time Point (AUClast) of PF-07261271: SAD Cohort
timeFrame: Predose and 0, 2, 4, 8, 12, 24, 48, 72, 192, 360, 768, 1104, 1464, 2184, 4344, 5064, 5784, 6504, 7224, 7944, 8664, 10824 hours post dose
measure: Area Under the Serum Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-07261271: SAD Cohort
timeFrame: Predose and 0, 2, 4, 8, 12, 24, 48, 72, 192, 360, 768, 1104, 1464, 2184, 4344, 5064, 5784, 6504, 7224, 7944, 8664, 10824 hours post dose
measure: Maximum Plasma Concentration (Cmax) of PF-07261271: SAD Cohort
timeFrame: Predose and 0, 2, 4, 8, 12, 24, 48, 72, 192, 360, 768, 1104, 1464, 2184, 4344, 5064, 5784, 6504, 7224, 7944, 8664, 10824 hours post dose
measure: Time to Maximum Plasma Concentration (Tmax) of PF-07261271: SAD Cohort
timeFrame: Predose and 0, 2, 4, 8, 12, 24, 48, 72, 192, 360, 768, 1104, 1464, 2184, 4344, 5064, 5784, 6504, 7224, 7944, 8664, 10824 hours post dose
measure: Terminal Elimination Half-life (t1/2) of PF-07261271: SAD Cohort
timeFrame: Predose and 0, 2, 4, 8, 12, 24, 48, 72, 192, 360, 768, 1104, 1464, 2184, 4344, 5064, 5784, 6504, 7224, 7944, 8664, 10824 hours post dose
measure: Area Under the Concentration Time Profile From Time Zero to Time Tau (τ), the Dosing Interval (AUCtau) of PF-07261271: MD Cohort
timeFrame: Predose and 0, 2, 4, 8, 12, 48, 96, 192, 360, 720, 744, 1224, 1584, 1944, 2664, 4104, 4824, 5544, 6264, 6984, 7704, 8424, 9144 and 11304 hours post-dose on Day 1 and 29
measure: Cmax of PF-07261271: MD Cohort
timeFrame: Predose and 0, 2, 4, 8, 12, 48, 96, 192, 360, 720, 744, 1224, 1584, 1944, 2664, 4104, 4824, 5544, 6264, 6984, 7704, 8424, 9144 and 11304 hours post-dose on Day 1 and 29
measure: Tmax of PF-07261271: MD Cohort
timeFrame: Predose and 0, 2, 4, 8, 12, 48, 96, 192, 360, 720, 744, 1224, 1584, 1944, 2664, 4104, 4824, 5544, 6264, 6984, 7704, 8424, 9144 and 11304 hours post-dose on Day 1 and 29
measure: Terminal Elimination Half-life (t1/2) of PF-07261271: MD Cohort
timeFrame: Predose and 0, 2, 4, 8, 12, 48, 96, 192, 360, 720, 744, 1224, 1584, 1944, 2664, 4104, 4824, 5544, 6264, 6984, 7704, 8424, 9144 and 11304 hours post-dose on Day 1 and 29
measure: Number of Participants With Anti-drug Antibodies (ADA) Against PF-07261271: SAD Cohort
timeFrame: Baseline up to 15 months
measure: Number of Participants With ADA Against PF-07261271: MD Cohort
timeFrame: Baseline up to 15.5 months
measure: Number of Participants With Neutralizing Antibodies (NAb) Against PF-07261271: SAD Cohort
timeFrame: Baseline up to 15 months
measure: Number of Participants With NAb Against PF-07261271: MD Cohort
timeFrame: Baseline up to 15.5 months
Other outcomes:
Locations:
city: Lake Forest
country: United States
facility: Orange County Research Center
state: California
city: Tustin
country: United States
facility: Orange County Research Center
state: California
city: Eatontown
country: United States
facility: Clinilabs
state: New Jersey
city: Salt Lake City
country: United States
facility: ICON
state: Utah
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: