A Phase 1 Study To Evaluate The Safety, Tolerability, Immunogenicity, Pharmacokinetics And Pharmacodynamics Of Multiple Ascending Doses Of Pf-06342674 (rn168) In Adults With Type 1 Diabetes

Number of Participants With All-Causality Treatment-Emergent Hypoglycemic Adverse Events

时间窗: 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 Serum Anti-PF-06342674 Antibody Response Listed by Visit

时间窗: 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

Number of Participants With Dose Limiting or Intolerable Treatment Related Adverse Events (AEs)

时间窗: 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)

时间窗: 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

时间窗: 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

时间窗: 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 Listed by CTCAE Grade

时间窗: 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 Vital Signs That Met the Criteria for Potential Clinical Concern(Absolute Values)

时间窗: 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)

时间窗: 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 Electrocardiogram(ECG) Data That Met the Criteria for Potential Clinical Concern(Absolute Value)

时间窗: 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 Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)

时间窗: 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(Increases From Baseline)

时间窗: 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(Increases From Baseline)

时间窗: 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.