drugset / Trial / NCT03366688
Single Ascending Dose Study of PCSK-9 Inhibitor (IBI306) in Healthy Subjects.
RandomizedParallel-groupDouble-blindOther
Summary
IBI306 is a fully human monoclonal antibody that binds proprotein convertase substilisin/kexin type 9 (PCSK9), preventing its interaction with the low-density lipoprotein cholesterol receptor (LDL-R) and thereby restoring LDL-R recycling and low-density lipoprotein cholesterol(LDL-C)uptake. This is a randomized, double-blind, placebo-controlled,single ascending dose study to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics and immunogenicity of IBI306 in healthy adults.
Timeline
- Start
- 2017-11-27
- Primary completion
- 2018-11-05
- Completion
- 2018-11-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Tafolecimab | Monoclonal antibody | 25 mg | Subcutaneous |
| Comparator | Tafolecimab | Monoclonal antibody | 75 mg | Subcutaneous |
| Comparator | Tafolecimab | Monoclonal antibody | 150 mg | Subcutaneous |
| Comparator | Tafolecimab | Monoclonal antibody | 300 mg | Subcutaneous |
| Comparator | Tafolecimab | Monoclonal antibody | 450 mg | Subcutaneous |
| Comparator | Tafolecimab | Monoclonal antibody | 600 mg | Subcutaneous |