MedTrace Logo

Phase 1b Study of DCR-AUD in Healthy Volunteers

NCT05845398 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-01-14

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

DCR-AUD

DCR-A1203, the drug substance of DCR-AUD, is a synthetic double-stranded (hybridized duplex) RNA oligonucleotide conjugated to GalNAc ligands that enable specific hepatic access and update after subcutaneous administration. DCR-AUD is a sterile solution of DCR-A1203 at a concentration of 160 mg/mL in water for injection (WFI).

DRUG

Placebo

0.9% saline for injection.

Sponsors & Collaborators

  • Dicerna Pharmaceuticals, Inc., a Novo Nordisk company

    lead INDUSTRY

Principal Investigators

  • John Hanrahan, MD, MPH · Dicerna Pharmaceuticals, Inc., a Novo Nordisk company

  • Lev G. Gertsik, MD · Parexel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-29
Primary Completion
2023-08-22
Completion
2023-08-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05845398 on ClinicalTrials.gov