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NCT04279613 · ClinicalTrials.gov registry record · Phase 1
A Multiple Ascending Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0361-0041
A Phase 1 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 1
- Development phase
- 47
- Enrollment target
NCT04279613 is a Phase 1 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 47 participants.
The verdict
NCT04279613, a Phase 1 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 47 participants
- Enrollment target
Study Summary
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.
Interventions
- OTHER Placebo
- DRUG NNC0361-0041
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2020-11-23 |
| Est. Completion | 2024-04-24 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04279613
The ClinicalTrials.gov registry entry for NCT04279613 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04279613 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04279613 about?
NCT04279613 is a clinical study titled "A Multiple Ascending Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0361-0041". 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.
What is the current status of trial NCT04279613?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2020-11-23. Estimated completion is 2024-04-24.
What interventions are being tested in trial NCT04279613?
The interventions under investigation include: Placebo (OTHER), NNC0361-0041 (DRUG).
Who is sponsoring clinical trial NCT04279613?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
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