drugset / Trial / NCT03933293
A Study to Evaluate the Safety and Efficacy of the PCSK9 Inhibitor AK102 in Patients With HoFH
RandomizedParallel-groupQuadruple-blindTreatment
Summary
AK102 is being developed for the treatment of HoFH. The study will be conducted in 2 parts, part 1 is open label, single arm study to evaluate the safety, tolerability and efficacy of PCSK9 inhibitor AK102, and part 2 is double blind, randomized, placebo controlled study to evaluate the efficacy and safety of PCSK9 inhibitor AK102. The treatment period will last 12 week.
Timeline
- Start
- 2019-05-13
- Primary completion
- 2021-03-15
- Completion
- 2021-03-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AK102 | Monoclonal antibody | 450 mg | Subcutaneous |
| Background | Ezetimibe | Unknown | — | — |