PF-07261271
DrugIV or SC
NCT Number: NCT05536440
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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1
Orange County Research Center, Lake Forest, California, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
IV or SC
IV or SC
Time frame: From start of study intervention (Day 1) up to end of study, approximately up to 15 months
An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the last follow-up date, were considered as TEAEs. AEs included all SAEs and Non-SAEs.
Time frame: From start of study intervention (Day 1) up to end of study, approximately of 15.5 months
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the last follow-up date, were considered as TEAEs. AEs included all SAEs and Non-SAEs.
Time frame: From start of study intervention (Day 1) up to end of study, approximately up to 15 months
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAEs were defined as any untoward medical occurrence that, at any dose, met one or more of the criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or other medically significant event.
Time frame: From start of study intervention (Day 1) up to end of study, approximately of 15.5 months
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAEs were defined as any untoward medical occurrence that, at any dose, met one or more of the criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or other medically significant event.
Time frame: From start of study intervention (Day 1) up to end of study, approximately up to 15 months
Criteria for abnormal values of vital signs: systolic blood pressure (millimeters of mercury [mmHg]) value less than (<) 90 mmHg, change greater than or equal to (>=) 30 mmHg increase, change >= 30 mmHg decrease; diastolic blood pressure (mmHg), value <50 mmHg, change >=20 mmHg increase, change >=20 mmHg decrease; pulse rate (beats per minute [bpm]) value <40bpm, value greater than (>) 120bpm. Clinical significance was determined based on investigator's discretion.
Time frame: From start of study intervention (Day 1) up to end of study, approximately of 15.5 months
Criteria for abnormal values of vital signs: systolic blood pressure (mmHg) value < 90 mmHg, change >= 30 mmHg increase, change >= 30 mmHg decrease; diastolic blood pressure (mmHg), value <50 mmHg, change >=20 mmHg increase, change >=20 mmHg decrease; pulse rate (bpm) value < 40bpm, value > 120bpm. Clinical significance was determined based on investigator's discretion.
Time frame: From start of study intervention (Day 1) up to end of study, approximately up to 15 months
Criteria:Hematology(Activated partial thromboplastin time>1.1*upper limit of normal(ULN); Basophils &eosinophils>1.2*ULN; erythrocytes,hematocrit,hemoglobin,lymphocytes,neutrophils <0.8*lower limit of normal(LLN); leukocytes <0.6*LLN, >1.5*ULN; monocytes >1.2*ULN; platelets <0.5*LLN; prothrombin international randomized ratio &prothrombin Time >1.1*ULN), clinical chemistry (alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase >3.0*ULN; albumin, protein <0.8*LLN, >1.2*ULN; bicarbonate, calcium, chloride, potassium <0.9*LLN,>1.1*ULN; bilirubin >1.5*ULN; creatinine >1.3*ULN; glucose, Glucose-FASTING <0.6*LLN,>1.5*ULN; Sodium <0.95*LLN,>1.05*ULN; Urate: >1.2*ULN;Urea Nitrogen: >1.3*ULN),urinalysis(Bacteria > 20;epithelial cells >=6;granular, hyaline, RBC&WBC casts >1;ketones,leukocyte esterase, nitrite, urine glucose, urine hemoglobin, urine protein>=1,urine erythrocytes,leukocytes >=20;pH(scalar)<4.5,>8.Clinical significance determined on investigator's discretion.
Time frame: From start of study intervention (Day 1) up to end of study, approximately of 15.5 months
Criteria:Hematology(Activated partial thromboplastin time>1.1*upper limit of normal(ULN); Basophils &eosinophils>1.2*ULN; erythrocytes,hematocrit,hemoglobin,lymphocytes,neutrophils <0.8*lower limit of normal(LLN); leukocytes <0.6*LLN, >1.5*ULN; monocytes >1.2*ULN; platelets <0.5*LLN; prothrombin international randomized ratio &prothrombin Time >1.1*ULN), clinical chemistry (alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase >3.0*ULN; albumin, protein <0.8*LLN, >1.2*ULN; bicarbonate, calcium, chloride, potassium <0.9*LLN,>1.1*ULN; bilirubin >1.5*ULN; creatinine >1.3*ULN; glucose, Glucose-FASTING <0.6*LLN,>1.5*ULN; Sodium <0.95*LLN,>1.05*ULN; Urate: >1.2*ULN;Urea Nitrogen: >1.3*ULN),urinalysis(Bacteria > 20;epithelial cells >=6;granular, hyaline, RBC&WBC casts >1;ketones,leukocyte esterase, nitrite, urine glucose, urine hemoglobin, urine protein>=1,urine erythrocytes,leukocytes >=20;pH(scalar)<4.5,>8.Clinical significance determined on investigator's discretion.
Time frame: From start of study intervention (Day 1) up to end of study, approximately up to 15 months
Criteria for abnormal values of ECG parameters: pulse rate (PR) interval greater than or equal to (>=)300 milliseconds (msec); PR interval change >=25 percent (%) or >=50 %, QRS interval >=140 msec and QRS interval change: >=50%. QT interval using Fridericia's correction (QTcF) range from 450 msec to less than (<)480 msec, less than (<) 480 msec to maximum less than or equal to (<=)500 msec, >500 msec, <=30 to <60 msec and >=60 msec. Only rows which included at least 1 participant with abnormality are reported in this outcome measure. Clinical significance was determined based on investigator's discretion.
Time frame: From start of study intervention (Day 1) up to end of study, approximately of 15.5 months
Criteria for abnormal values of ECG parameters: pulse rate (PR) interval greater than or equal to (>=)300 milliseconds (msec); PR interval change >=25 percent (%) or >=50 %, QRS interval >=140 msec and QRS interval change: >=50%. QT interval using Fridericia's correction (QTcF) range from 450 msec to less than (<)480 msec, less than (<) 480 msec to maximum less than or equal to (<=)500 msec, >500 msec, <=30 to <60 msec and >=60 msec. Only rows which included at least 1 participant with abnormality are reported in this outcome measure. Clinical significance was determined based on investigator's discretion.
Time frame: 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
AUClast was determined using Linear Log trapezoidal method.
Time frame: 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
AUCinf was determined as AUClast + (Clast*/kel), where Clast* is the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis.
Time frame: 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
Cmax was defined as maximum serum concentration.
Time frame: 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
Tmax was defined as time for Cmax.
Time frame: 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
t1/2 was determined using Loge (2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear -concentration time- curve.
Time frame: 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
AUCtau was defined as area under the concentration time profile from time zero to time tau (τ), the dosing interval, where tau=672 hours for every 4-week dosing. AUCtau was determined by Linear Log trapezoidal method.
Time frame: 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
Cmax was defined as maximum serum concentration.
Time frame: 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
Tmax was defined as time for Cmax.
Time frame: 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
t1/2 was determined using Loge (2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear -concentration time- curve.
Time frame: Baseline up to 15 months
ADA positive was defined as ADA titer >= 100; ADA negative defined as ADA titer < 100. Baseline was defined as the last pre-dose measurement
Time frame: Baseline up to 15.5 months
ADA positive defined as ADA titer >= 100; ADA negative defined as ADA titer < 100. Baseline was defined as the last pre-dose measurement.
Time frame: Baseline up to 15 months
NAb was determined by electrochemiluminescent (ECL) competitive ligand binding assay using the Meso Scale Discovery (MSD) platform.
Time frame: Baseline up to 15.5 months
NAb was determined by electrochemiluminescent (ECL) competitive ligand binding assay using the Meso Scale Discovery (MSD) platform.
Pfizer
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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