NCT05845398

Phase 1b Study of DCR-AUD in Healthy Volunteers

A Phase 1b, Double-blind, Placebo-controlled, Repeat-dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of DCR-AUD in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Dicerna Pharmaceuticals, Inc., a Novo Nordisk company · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

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

• Alcohol Use Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-01-29
• Primary completion: 2023-08-22
• Completion: 2023-08-22
• First posted: 2023-05-06
• Last updated: 2026-01-14
• Results posted: 2025-01-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study