A Study To Assess The Safety Of PF-06342674 In Adults With Type 1 Diabetes

NCT02038764

Last updated date
Study Location
VA San Diego Healthcare System (Drug Shipment)
San Diego, California, 92161, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 1 Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study To Assess The Safety Of PF-06342674 In Adults With Type 1 Diabetes
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Diabetes Mellitus, Type 1
Intervention  ICMJE
  • Drug: Placebo
    Placebo
  • Biological: PF-06342674 Dose A
    Multiple SC Doses
  • Biological: PF-06342674 Dose B
    Multiple SC Doses
  • Biological: PF-06342674 Dose C
    Multiple SC Doses
  • Biological: PF-06342674 Dose D
    Multiple SC Doses
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
  • Experimental: PF-06342674
    Interventions:
    • Biological: PF-06342674 Dose A
    • Biological: PF-06342674 Dose B
    • Biological: PF-06342674 Dose C
    • Biological: PF-06342674 Dose D
Publications * 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). pii: 126054. doi: 10.1172/jci.insight.126054.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 2, 2016)
37
Original Estimated Enrollment  ICMJE
 (submitted: January 15, 2014)
40
Actual Study Completion Date  ICMJE September 13, 2016
Actual Primary Completion Date September 13, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02038764
Other Study ID Numbers  ICMJE B4351003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP