Status:
COMPLETED
Study of Safety and Tolerability of DCR HBVS
Lead Sponsor:
Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
DCR-HBVS will be evaluated for safety and efficacy in healthy volunteers and chronic hepatitis B patients.
Detailed 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)...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 12 2022
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT03772249
Start Date
December 28 2018
End Date
July 12 2022
Last Update
September 19 2024
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
Monash Health
Clayton, Victoria, Australia, 3168
2
St Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia, 3065
3
Queen Mary Hospital (The University of Hong Kong)
Hong Kong, Hong Kong
4
Clinical Site
Auckland, New Zealand, 1023