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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: Completed Phase 1 study, sponsored by Dicerna Pharmaceuticals, Inc., a Novo Nordisk company.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
An Adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. A TEAE is defined as an AE that begins or that worsens in severity after the s
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 |
What the finished NCT05845398 record still lists
NCT05845398 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05845398 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05845398's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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