Ignite Creation Date:
2024-05-06 @ 12:28 PM
Last Modification Date:
2024-10-26 @ 12:59 PM
Study NCT ID:
NCT03772249
Status:
COMPLETED
Last Update Posted:
2024-07-11
First Post:
2018-12-03
Brief Title:
Study of Safety and Tolerability of DCR HBVS
Sponsor:
Dicerna Pharmaceuticals Inc a Novo Nordisk company
Organization:
Novo Nordisk AS
Study Overview
Official Title:
A Three-Part Phase 1 Safety Tolerability Pharmacokinetics and Pharmacodynamics Study of DCR-HBVS in Healthy Volunteers and Patients With Chronic Hepatitis B
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1220-7021 | OTHER | World Health Organization WHO | None |