Study of Safety and Tolerability of DCR HBVS

  • STATUS
    Recruiting
  • End date
    Jul 25, 2022
  • participants needed
    70
  • sponsor
    Dicerna Pharmaceuticals, Inc.
Updated on 25 January 2021
Investigator
VP, Clinical Development
Primary Contact
Queen Mary Hospital (The University of Hong Kong) (4.4 mi away) Contact
+8 other location
liver disease
chronic hepatitis

Summary

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

Description

DCR HBVS is being developed for the treatment of chronic hepatitis B (CHB) in adults. The study will be conducted in 3 parts, a single ascending-dose (SAD) phase in normal healthy volunteers (Group A), a single-dose (SD) phase in patients with CHB (Group B), and a multiple ascending-dose (MAD) phase in patients with CHB (Group 1c-3c). Cohort 4c is a single ascending dose with a possible duration of up to 48 weeks. Cohort 5c is a multiple dose cohort with a possible duration of up to 72 weeks.

Details
Condition chronic hepatitis b
Treatment DCR-HBVS, Placebo for DCR-HBVS
Clinical Study IdentifierNCT03772249
SponsorDicerna Pharmaceuticals, Inc.
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Healthy at the time of screening as determined by medical evaluation
Capable of giving informed consent
-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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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