Trials / Completed
CompletedNCT05961098
A Study of RBD1016 in CHB Participants
A Phase II Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of RBD1016 Injection in Participants With Chronic Hepatitis B
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Suzhou Ribo Life Science Co. Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This study is a multi-center, randomized, double-blind, placebo-controlled clinical study to assess the safety, efficacy, PK and immunogenicity of RBD1016 injection on NAs background treatment in CHB participants.
Detailed description
The study consists of screening period, treatment period, and FU period. It is divided into 3 dose groups, namely 100 mg Q4W, 200 mg Q4W and 200 mg Q12W. Each group will enroll 16 eligible participants, with 12 participants receiving RBD1016 injection and 4 participants receiving placebo.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RBD1016 | RBD1016 with NAs background treatment will be explored. |
Timeline
- Start date
- 2023-10-11
- Primary completion
- 2025-04-29
- Completion
- 2025-10-15
- First posted
- 2023-07-27
- Last updated
- 2025-12-09
Locations
4 sites across 2 countries: China, Sweden
Source: ClinicalTrials.gov record NCT05961098. Inclusion in this directory is not an endorsement.