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NCT05845398 · ClinicalTrials.gov registry record · Phase 1
Phase 1b Study of DCR-AUD in Healthy Volunteers
A Phase 1 study, sponsored by Dicerna Pharmaceuticals, Inc., a Novo Nordisk company.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT05845398 is a Phase 1 study that has completed, run by Dicerna Pharmaceuticals, Inc., a Novo Nordisk company. The registered enrollment target is 16 participants.
The verdict
NCT05845398, a Phase 1 study, has completed, sponsored by Dicerna Pharmaceuticals, Inc., a Novo Nordisk company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to test the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of of repeat doses of DCR-AUD in adult healthy volunteers who are social drinkers. The main questions it aims to answer are: * Are repeat doses of DCR-AUD safe and well-tolerated in healthy adults who are social drinkers? * How does the drug behave inside the human body and how it is removed from the human body? * What are the symptoms the drug may cause with alcohol consumption? Participants will: * Receive multiple doses of DCR-AUD. * Have assessment visits through Week 24. * Participate in up to 10 Ethanol Interaction Assessments (EIAs) to see how the body is affected by DCR-AUD. Researchers will compare the groups of participates who receive study drug with the group of participants who receive placebo to see if the study drug is safe and tolerable and whether the study drug has any real effect.
Interventions
- DRUG Placebo
- DRUG DCR-AUD
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2023-01-29 |
| Est. Completion | 2023-08-22 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05845398
The ClinicalTrials.gov registry entry for NCT05845398 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dicerna Pharmaceuticals, Inc., a Novo Nordisk company, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05845398 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05845398 about?
NCT05845398 is a clinical study titled "Phase 1b Study of DCR-AUD in Healthy Volunteers". The goal of this clinical trial is to test the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of of repeat doses of DCR-AUD in adult healthy volunteers who are social drinkers. The main questions it aims to answer are: * Are repeat doses of DCR-AUD safe and well-tolerated i...
What is the current status of trial NCT05845398?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2023-01-29. Estimated completion is 2023-08-22.
What interventions are being tested in trial NCT05845398?
The interventions under investigation include: Placebo (DRUG), DCR-AUD (DRUG).
Who is sponsoring clinical trial NCT05845398?
This trial is sponsored by Dicerna Pharmaceuticals, Inc., a Novo Nordisk company, which has 13 total clinical trials registered on ClinicalTrials.gov.
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