drugset / Trial / NCT04169386
A Study of PCSK9 Inhibitor AK102 in Healthy Subjects
RandomizedParallel-groupTriple-blindTreatment
Summary
This is a first-in-human,randomized, double-blind, placebo-controlled, single dose escalation, phase 1 study to evaluate the safety, tolerability, PK/PD and immunogenicity of AK102 administered subcutaneously in healthy subjects. Subjects will be randomized into 4 planned single dose escalation cohorts or placebo cohort.
Timeline
- Start
- 2018-05-23
- Primary completion
- 2018-11-22
- Completion
- 2018-11-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AK102 | Monoclonal antibody | 75 mg | Subcutaneous |
| Subject | AK102 | Monoclonal antibody | 150 mg | Subcutaneous |
| Subject | AK102 | Monoclonal antibody | 300 mg | Subcutaneous |
| Subject | AK102 | Monoclonal antibody | 500 mg | Subcutaneous |