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RNAi Therapeutics

Study of DCR-AUD in Healthy Volunteers

Phase 1
Waitlist Available
Led By Lev G. Gertsik, MD
Research Sponsored by Dicerna Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks

Summary

This trial is testing DCR-AUD, a new treatment for adults with alcohol use disorder. It aims to potentially reduce alcohol cravings or effects. The study will check its safety and how well people tolerate it.

Eligible Conditions
  • Alcoholism

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence and severity of AEs, SAEs, and DLTs as assessed by CTCAE v5.0.
Number of participants with abnormalities in vital signs, electrocardiogram (ECG), and clinically significant laboratory findings.
Secondary study objectives
Facial skin temperature.
Heart rate.
Plasma acetaldehyde levels.
+6 more

Trial Design

8Treatment groups
Experimental Treatment
Placebo Group
Group I: Cohort 4 (OPTIONAL) DCR-AUDExperimental Treatment1 Intervention
Single dose, subcutaneous administration of 960 mg of DCR-AUD (HV)
Group II: Cohort 3 DCR-AUDExperimental Treatment1 Intervention
Single dose, subcutaneous administration of 480 mg of DCR-AUD (HV)
Group III: Cohort 2 DCR-AUDExperimental Treatment1 Intervention
Single dose, subcutaneous administration of 240 mg of DCR-AUD (HV)
Group IV: Cohort 1 DCR-AUDExperimental Treatment1 Intervention
Single dose, subcutaneous administration of 80 mg of DCR-AUD (HV)
Group V: Cohort 1 DCR-AUD PlaceboPlacebo Group1 Intervention
Single dose, subcutaneous administration of Placebo for DCR-AUD (HV), volume to match active single dose
Group VI: Cohort 2 DCR-AUD PlaceboPlacebo Group1 Intervention
Single dose, subcutaneous administration of Placebo for DCR-AUD (HV), volume to match active single dose
Group VII: Cohort 3 DCR-AUD PlaceboPlacebo Group1 Intervention
Single dose, subcutaneous administration of Placebo for DCR-AUD (HV), volume to match active single dose
Group VIII: Cohort 4 (OPTIONAL) DCR-AUD PlaceboPlacebo Group1 Intervention
Single dose, subcutaneous administration of Placebo for DCR-AUD (HV), volume to match active single dose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DCR-AUD
2023
Completed Phase 1
~60

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Dicerna Pharmaceuticals, Inc.Lead Sponsor
14 Previous Clinical Trials
459 Total Patients Enrolled
Dicerna Pharmaceuticals, Inc., a Novo Nordisk companyLead Sponsor
18 Previous Clinical Trials
539 Total Patients Enrolled
1 Trials studying Alcoholism
16 Patients Enrolled for Alcoholism
ParexelIndustry Sponsor
314 Previous Clinical Trials
96,750 Total Patients Enrolled
John Hanrahan, MD, MPHStudy DirectorDicerna Pharmaceuticals, Inc., a Novo Nordisk company
1 Previous Clinical Trials
16 Total Patients Enrolled
1 Trials studying Alcoholism
16 Patients Enrolled for Alcoholism
Lev G. Gertsik, MDPrincipal InvestigatorParexel
1 Previous Clinical Trials
16 Total Patients Enrolled
1 Trials studying Alcoholism
16 Patients Enrolled for Alcoholism
~8 spots leftby Dec 2025
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