Study of Safety and Tolerability of DCR HBVS

• Status: Active, not recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

Summary

DCR-HBVS will be evaluated for safety and efficacy in healthy volunteers and chronic hepatitis B patients.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dicerna Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

• Healthy at the time of screening as determined by medical evaluation.

• Capable of giving informed consent.

• 12-lead ECG within normal limits or with no clinically significant abnormalities.

• Negative screen for alcohol or drugs of abuse.

• Non-smokers for at least 3 months with a negative urinary cotinine concentration at screening.

• BMI within range 18.0 - 32.0 kg/m2 (inclusive).

• Female participants not pregnant, not breastfeeding, and not of childbearing potential or willing to follow contraceptive guidance.

• Chronic hepatitis B infection (Group B and C only).

• Clinical history compatible with compensated liver disease with no evidence of cirrhosis (Group B and C only).

• Continuously on nucleotides (NUC) therapy for at least 12 weeks prior to screening (Group C only).

Exclusion Criteria:

• History of any medical condition that may interfere with the absorption, distribution, or elimination of study drug.

• Poorly controlled or unstable hypertension.

• History of diabetes mellitus treated with insulin or hypoglycemic agents.

• History of asthma requiring hospital admission within the preceding 12 months.

• Evidence of G-6-PD deficiency.

• Currently poorly controlled endocrine conditions, excluding thyroid conditions.

• History of multiple drug allergies or history of allergic reaction to an oligonucleotide or GalNAc.

• Clinically relevant surgical history.

• Use of prescription medications (excluding contraception for women) within 4 weeks prior to the administration of study intervention.

• Use of clinically relevant over-the-counter medication or supplements (excluding routine vitamins) within 7 days of first dosing.

• Has received an investigational agent within the 3 months prior to dosing or is in follow-up of another study.

• Antiviral therapy (other than entecavir or tenofovir) within 3 months of screening or treatment with interferon in the last 3 years (Group B and C only).

• Use within the last 6 months of anticoagulants or systemically administered corticosteroids, immunomodulators, or immunosuppressants (Group B and C only).