A Single Dose Escalation Study of PCSK9 Inhibitor (JS002) in Health Subjects

Summary

JS002 is a recombinant humanized Anti- PCSK9 monoclonal antibody; This is a phase Ia, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single subcutaneous injection of JS002 in healthy subjects. In this study, the dose ascending design includes five dose level cohorts (15 mg, 50 mg, 150 mg, 300 mg, and 450 mg) administered by subcutaneous injection, and three intravenous administration cohorts (15 mg, 150 mg, and 450 mg). Each cohort will enroll 8 to 12 subjects (distribution of study drug and placebo in a 3:1 ratio). The duration of the study is 84-day per subjects.

Timeline

Start

2017-12-11

Primary completion

2018-08-14

Completion

2018-08-14

Drugs

Indications