NCT04197817

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

A Randomized, Double-blind, Placebo-controlled, Single-dose Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JS002 (Recombinant Humanized Anti-PCSK9 Monoclonal Antibody) Injection in Healthy Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Shanghai Junshi Bioscience Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	JS002	JS002, Subcutaneous or intravenous injection of a single dose of JS002, dose cohort according to ascending dose design
DRUG	Placebo	Placebo,Subcutaneous or intravenous injection of a single dose of placebo, dose cohort according to ascending dose design

Timeline

• Start date: 2017-12-11
• Primary completion: 2018-08-14
• Completion: 2018-08-14
• First posted: 2019-12-13
• Last updated: 2019-12-13

Locations

1 site across 1 country: China