A Multiple Ascending Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0361-0041

PHASE1CompletedINTERVENTIONAL
Enrollment

47

Participants

Timeline

Start Date

November 23, 2020

Primary Completion Date

August 31, 2023

Study Completion Date

April 24, 2024

Conditions
Type I Diabetes
Interventions
DRUG

NNC0361-0041

Recombinant supercoiled plasmid encoding four human proteins: (pre-proinsulin (PPI), transforming growth factor β1 (TGF-β1), interleukin-10 (IL-10), and interleukin-2 (IL-2) is administered s.c. via syringe and needle.

OTHER

Placebo

Placebo

Trial Locations (16)

10032

The Naomi Berrie Diabetes Center at Columbia University Medical Center, New York

15224

University of Pittsburgh, Pittsburgh

30329

Emory Children's Center, Atlanta

32610

University of Florida, Gainesville

37232

Vanderbilt Eskind Diabetes Center, Nashville

46202

Indiana University - Riley Hospital for Children, Indianapolis

55466

Regents of the University of Minnesota, Minneapolis

64108

The Children's Mercy Hospital, Kansas City

75390

University of Texas Southwestern Medical Center, Dallas

80045

Barbara Davis Center at University of Colorado Anschutz Medical Campus, Aurora

92868

Children's Hospital of Orange County, Orange

94143

University of California - San Francisco, San Francisco

94305

Stanford University, Stanford

98101

Benaroya Research Institute, Seattle

06519

Yale University School of Medicine, New Haven

02215

Joslin Diabetes Center, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novo Nordisk A/S

INDUSTRY

lead

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH