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PF-06342674 Dose A

Phase 1

Diabetes Mellitus, Type 1 | Monoclonal antibody | Metabolic |Pfizer, Inc.|Last Updated: Aug 3, 2018

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment37

FDA Designations

No designations recorded

Clinical trial landscape

PF-06342674 Dose A · 2 trials · 2 indications

Phase 1 2
NCT02038764A Study To Assess The Safety Of PF-06342674 In Adults With Type 1 DiabetesDiabetes Mellitus, Type 1
COMPLETED37 Analytics
NCT01740609A Study To Assess The Safety Of PF-06342674 In Healthy VolunteersHealthy
COMPLETED80 Analytics
PHASE1COMPLETED
A Study To Assess The Safety Of PF-06342674 In Adults With Type 1 Diabetes
Diabetes Mellitus, Type 1Unlock trial analytics
PHASE1COMPLETED
A Study To Assess The Safety Of PF-06342674 In Healthy Volunteers
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Dose Limiting or Intolerable Treatment Related Adverse Events (AEs)
Day 1 through Day 127

Number of participants with dose limiting or intolerable treatment related adverse events (AEs) was reported. An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage.

Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs)
Day 1 through Day 127

Number of participants with all-causality treatment emergent adverse events were reported. An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were those AEs with initial onset or increasing in severity after the first dose of study drug. TEAEs included both serious and non-serious AE

Number of Participants With Treatment-Related TEAEs
Day 1 through Day 127

Number of participants with treatment-related TEAEs were reported. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were those AEs with initial onset or increasing in severity after the first dose of study drug.

Number of Participants With All-Causality TEAEs Listed by Common Terminology Criteria for Adverse Events (CTCAE) Grade
Day 1 through Day 127

TEAEs were those AEs with initial onset or increasing in severity after the first dose of study drug. CTCAE version 4.03 was used to grade the severity of TEAEs. Grade 1 referred to mild AEs; Grade 2 referred to moderate AEs; Grade 3 referred to severe AEs; Grade 4 referred to AEs with life-threatening consequences, and urgent intervention was needed to manage them; Grade 5 referred to death related to AE.

Number of Participants With All-Causality Treatment-Emergent Hypoglycemic Adverse Events
Day 1 through Day 127

Number of participants with all-causality treatment-emergent hypoglycemic adverse events was reported. Any blood glucose values less than(\<)55 mg/dL with or without symptoms was reported as adverse events of hypoglycemia.

Number of Participants With All-Causality Treatment-Emergent Hypoglycemic Adverse Events Listed by CTCAE Grade
Day 1 through Day 127

Any blood glucose values \<55 mg/dL with or without symptoms was reported as adverse events of hypoglycemia. CTCAE version 4.03 was used to grade the severity of TEAEs. Grade 1 referred to mild AEs; Grade 2 referred to moderate AEs; Grade 3 referred to severe AEs; Grade 4 referred to AEs with life-threatening consequences, and urgent intervention was needed to manage them; Grade 5 referred to death related to AE.

Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Day 1 through Day 127

The following laboratory test parameters were evaluated in this study: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, absolute total neutrophils, absolute eosinophils, absolute basophils, absolute monocytes, and absolute lymphocytes),coagulation (partial thromboplastin time, prothrombin, and prothrombin international ratio), liver function(total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, total protein, and albumin), renal function (blood urea nitrogen, creatinine, and uric acid), electrolytes (sodium, potassium, chloride, calcium, and venous bicarbonate), clinical chemistry(glucose, glycosylated, and hemoglobin), and urinalysis (pH, qualitative glucose, qualitative protein, qualitative blood, urobilinogen, qualitative bilirubin, nitrites, leukocyte, esterase and microscopy).

Number of Participants With Vital Signs That Met the Criteria for Potential Clinical Concern(Absolute Values)
Day 1 through Day 127

Number of participants with vital signs data of absolute values meeting criteria of potential clinical concern. Absolute values were analyzed for systolic blood pressure (SBP), diastolic blood pressure (DBP), and pulse rate. Number of participants with vital signs data meeting the following criteria was reported: Criterion A: SBP \<90 millimeter of mercury(mmHg); Criterion B: DBP \<50 mmHg; Criterion C: pulse rate \< 40 beats per minute(BPM); Criterion D: pulse rate \>120 BPM

Number of Participants With Vital Signs That Met the Criteria for Potential Clinical Concern(Decreases From Baseline)
Day 1 through Day 127

The number of participants with vital signs data of maximum decrease from baseline meeting the following criteria was reported: Criterion A: maximum decrease from baseline in systolic BP \>= 30 mmHg; Criterion B: maximum decrease from baseline in diastolic BP \>=20 mmHg

Number of Participants With Vital Signs That Met the Criteria for Potential Clinical Concern(Increases From Baseline)
Day 1 through Day 127

The number of participants with vital signs data of maximum increase from baseline meeting the following criteria was reported: Criterion A: maximum increase from baseline in systolic BP \>= 30 mmHg; Criterion B: maximum increase from baseline in diastolic BP \>= 20 mmHg

Number of Participants With Electrocardiogram(ECG) Data That Met the Criteria for Potential Clinical Concern(Absolute Value)
Day 1 through Day 127

The number of participants with ECG absolute values meeting the following criteria was reported: Criterion A: maximum PR interval (time from the beginning of P wave to the start of QRS complex, corresponding to the end of atrial depolarization and onset of ventricular depolarization) \>=300 msec; Criterion B: maximum QRS complex(time from Q wave to the end of S wave, corresponding to ventricle depolarization) \>=200 msec; Criterion C: maximum QTcF interval (time from the beginning of Q wave to the end of T wave corresponding to electrical systole, corrected for heart rate using Fridericia's formula) 450-\<480 msec; Criterion D: maximum QTcF interval 480-\<500 msec; Criterion E: maximum QTcF interval (Fridericia's correction) \>=500 msec

Number of Participants With Electrocardiogram(ECG) Data That Met the Criteria for Potential Clinical Concern(Increases From Baseline)
Day 1 through Day 127

Number of participants with ECG meeting the following criteria was reported: Criterion A: maximum PR interval increase from baseline percentage change (PctChg)\>= 25/50%; Criterion B: maximum QRS complex increase from baseline PctChg \>= 25/50%; Criterion C: maximum QTcF interval increase from baseline 30\<=change\<60 msec; Criterion D: maximum QTcF interval increase from baseline change \>=60 msec.

Number of Participants With Serum Anti-PF-06342674 Antibody Response Listed by Visit
Day 1, Day 15, Day 29, Day 57, Day 85, and Day127 and follow-up visits

Number of participants with serum anti-PF-06342674 antibody response to the intramuscular tetanus vaccine was reported. Positive Anti-PF-06342674 Antibody response is defined as anti-tetanus toxoid immunoglobulin G (IgG) titer value \>=100

Incidence of dose limiting or intolerable treatment related AEs
60 days
Incidence of treatment emergent AEs
60 days
Incidence of abnormal laboratory findings
60 days
Changes from baseline in safety laboratory assessments
60 days
Abnormal and clinically relevant changes in vital signs, blood pressure, and ECG parameters
60 days
Incidence of anti-drug-antibodies
60 days
Severity of treatment emergent AEs
60 days
Causal relationship of treatment emergent AEs
60 days

Secondary Endpoints

Area Under Concentration-Time Curve From Time Zero to Time Tau(AUCtau) on Day 1 and Day 71
0,1,4 hours post-dose on Day 1 and Day 71
Apparent Oral Clearance (CL/F) on Day 71
0,1,4 hours post-dose on Day 71
Maximum Observed Plasma Concentration (Cmax) on Day 1 and Day 71
0, 1, 4 hours post-dose on Day 1 and Day 71
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORPlacebo
PF-06342674EXPERIMENTAL -
1. PlaceboPLACEBO_COMPARATORPlacebo
2.0EXPERIMENTAL -

Interventions

NameTypeDescription
PlaceboDRUGPlacebo
PF-06342674 Dose ABIOLOGICALMultiple SC Doses
PF-06342674 Dose BBIOLOGICALMultiple SC Doses
PF-06342674 Dose CBIOLOGICALMultiple SC Doses
PF-06342674 Dose DBIOLOGICALMultiple SC Doses
PF-06342674 Dose EBIOLOGICALSingle SC Dose
PF-06342674 Dose FBIOLOGICALSingle IV Dose
PF-06342674 Dose GBIOLOGICALSingle SC Dose
PF-06342674 Dose HBIOLOGICALSingle IV Dose
PF-06342674 Dose IBIOLOGICALSingle SC Dose
PF-06342674 Dose JBIOLOGICALSingle IV Dose
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: * Women and men age 18 and older. * Diagnosis of type 1 diabetes within 2 years of randomization. * Peak stimulated C-peptide levels ≥ 0.15 ng/mL. Exclusion Criteria: * Anticipated ongoing use of diabetes medications other than insulin. * Evidence or history of diabetic compli...

Countries:United States
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Frequently asked questions about PF-06342674 Dose A

What is PF-05335810 Dose A?

PF-05335810 Dose A is an investigational monoclonal antibody being developed by Pfizer, Inc. (NYSE: PFE) for metabolic conditions. It is in Phase 1 clinical development for hypercholesterolemia, with studies also conducted in healthy volunteers and adults with Type 1 diabetes.

What is PF-05335810 Dose A used for?

PF-05335810 Dose A is being studied for use in hypercholesterolemia, a condition of high cholesterol. Clinical trials have also assessed its safety in healthy volunteers and in adults with Type 1 diabetes, though the primary focus is on hypercholesterolemia.

Who makes PF-05335810 Dose A?

PF-05335810 Dose A is developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical development.

What phase is PF-05335810 Dose A in?

PF-05335810 Dose A is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are completed, and the drug remains under study for metabolic indications.

What clinical trials is PF-05335810 Dose A in?

PF-05335810 Dose A was studied in a completed Phase 1 trial (NCT01720537) assessing safety in hypercholesterolemic subjects, with 133 participants in the United States. Additional completed trials (NCT01740609, NCT02038764) evaluated related compounds in healthy volunteers and Type 1 diabetes patients.