A Multiple Ascending Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0361-0041
Public ClinicalTrials.gov record NCT04279613. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multiple Ascending Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0361-0041 Administered Subcutaneously to Patients With Type 1 Diabetes Mellitus
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The trial is a placebo-controlled, double-blinded within cohorts, randomized, multiple ascending dose trial with a sequential trial design. The primary outcome is to investigate the safety and tolerability of ascending subcutaneous weekly doses of NNC0361-0041 plasmid in patients with T1D.
Study identification
- NCT ID
- NCT04279613
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 47 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 45 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 22, 2020
- Primary completion
- Aug 30, 2023
- Completion
- Apr 23, 2024
- Last update posted
- May 19, 2025
2020 – 2024
United States locations
- U.S. sites
- 16
- U.S. states
- 14
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital of Orange County | Orange | California | 92868 | — |
| University of California - San Francisco | San Francisco | California | 94143 | — |
| Stanford University | Stanford | California | 94305 | — |
| Barbara Davis Center at University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | — |
| Yale University School of Medicine | New Haven | Connecticut | 06519 | — |
| University of Florida | Gainesville | Florida | 32610 | — |
| Emory Children's Center | Atlanta | Georgia | 30329 | — |
| Indiana University - Riley Hospital for Children | Indianapolis | Indiana | 46202 | — |
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | — |
| Regents of the University of Minnesota | Minneapolis | Minnesota | 55466 | — |
| The Children's Mercy Hospital | Kansas City | Missouri | 64108 | — |
| The Naomi Berrie Diabetes Center at Columbia University Medical Center | New York | New York | 10032 | — |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | — |
| Vanderbilt Eskind Diabetes Center | Nashville | Tennessee | 37232 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Benaroya Research Institute | Seattle | Washington | 98101 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04279613, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 19, 2025 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04279613 live on ClinicalTrials.gov.