Clinical trial NCT02038764: A Study To Assess The Safety Of PF-06342674 In Adults With Type 1 Diabetes
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 1
Keywords: Phase 1
RN168
Adults
Type 1 Diabetes
T1D
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-01-17
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of multiple doses of PF-06342674. Several dose levels will be evaluated.


Eligibility criteria: 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 complications with significant end-organ damage.
* Episode of severe hypoglycemia within 60 days of randomization.
* Multiple hospitalizations for diabetic ketoacidosis.

Primary outcomes:
measure: Number of Participants With Dose Limiting or Intolerable Treatment Related Adverse Events (AEs)
timeFrame: Day 1 through Day 127
measure: Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs)
timeFrame: Day 1 through Day 127
measure: Number of Participants With Treatment-Related TEAEs
timeFrame: Day 1 through Day 127
measure: Number of Participants With All-Causality TEAEs Listed by Common Terminology Criteria for Adverse Events (CTCAE) Grade
timeFrame: Day 1 through Day 127
measure: Number of Participants With All-Causality Treatment-Emergent Hypoglycemic Adverse Events
timeFrame: Day 1 through Day 127
measure: Number of Participants With All-Causality Treatment-Emergent Hypoglycemic Adverse Events Listed by CTCAE Grade
timeFrame: Day 1 through Day 127
measure: Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
timeFrame: Day 1 through Day 127
measure: Number of Participants With Vital Signs That Met the Criteria for Potential Clinical Concern(Absolute Values)
timeFrame: Day 1 through Day 127
measure: Number of Participants With Vital Signs That Met the Criteria for Potential Clinical Concern(Decreases From Baseline)
timeFrame: Day 1 through Day 127
measure: Number of Participants With Vital Signs That Met the Criteria for Potential Clinical Concern(Increases From Baseline)
timeFrame: Day 1 through Day 127
measure: Number of Participants With Electrocardiogram(ECG) Data That Met the Criteria for Potential Clinical Concern(Absolute Value)
timeFrame: Day 1 through Day 127
measure: Number of Participants With Electrocardiogram(ECG) Data That Met the Criteria for Potential Clinical Concern(Increases From Baseline)
timeFrame: Day 1 through Day 127
measure: Number of Participants With Serum Anti-PF-06342674 Antibody Response Listed by Visit
timeFrame: Day 1, Day 15, Day 29, Day 57, Day 85, and Day127 and follow-up visits
Secondary outcomes:
measure: Area Under Concentration-Time Curve From Time Zero to Time Tau(AUCtau) on Day 1 and Day 71
timeFrame: 0,1,4 hours post-dose on Day 1 and Day 71
measure: Apparent Oral Clearance (CL/F) on Day 71
timeFrame: 0,1,4 hours post-dose on Day 71
measure: Maximum Observed Plasma Concentration (Cmax) on Day 1 and Day 71
timeFrame: 0, 1, 4 hours post-dose on Day 1 and Day 71
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1 and Day 71
timeFrame: 0, 1, 4 hours post-dose on Day 1 and Day 71
measure: Plasma Decay Half-Life (t1/2) on Day 71
timeFrame: 0, 1, 4 hours post-dose on Day 71
measure: Apparent Volume of Distribution (Vz/F) on Day 71
timeFrame: 0, 1, 4 hours post-dose on Day 71
measure: Accumulation Ratio (Rac) on Day 71
timeFrame: 0, 1, 4, hours post-dose on Day 71
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System (Drug Shipment)
state: California
city: San Diego
country: United States
facility: Veterans Administration San Diego Healthcare System
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Aurora
country: United States
facility: Barbara Davis Center
state: Colorado
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: New Haven
country: United States
facility: Yale New Haven Hospital - Investigational Drug Services
state: Connecticut
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Chicago
country: United States
facility: Duchossois Center for Advanced Medicine
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Clinical Resource Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Worcester
country: United States
facility: Umass Memorial Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
city: Minneapolis
country: United States
facility: University Of Minnesota Fairview Pharmacy Services
state: Minnesota
city: Minneapolis
country: United States
facility: University Of Minnesota Medical School
state: Minnesota
city: Saint Louis
country: United States
facility: Barnes- Jewish HOSP Att: Kathryn Vehe
state: Missouri
city: Saint Louis
country: United States
facility: Washington University - Center for Advanced Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Durham
country: United States
facility: Duke Clinical Research Unit
state: North Carolina
city: Durham
country: United States
facility: Duke University Health Systems (DUHS) Investigational Drug Services
state: North Carolina
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Herold KC, Bucktrout SL, Wang X, Bode BW, Gitelman SE, Gottlieb PA, Hughes J, Joh T, McGill JB, Pettus JH, Potluri S, Schatz D, Shannon M, Udata C, Wong G, Levisetti M, Ganguly BJ, Garzone PD; RN168 Working Group. Immunomodulatory activity of humanized anti-IL-7R monoclonal antibody RN168 in subjects with type 1 diabetes. JCI Insight. 2019 Dec 19;4(24):e126054. doi: 10.1172/jci.insight.126054.