NCT04169386

A Study of PCSK9 Inhibitor AK102 in Healthy Subjects

A First-in-Human,Randomized, Double-Blind, Placebo-Controlled, Single Dose Escalation,Phase 1 Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Pharmacodynamics of AK102 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hypercholesterolaemia

Interventions

Type	Name	Description
DRUG	AK102	AK102 single dose administered subcutaneously
DRUG	Placebo	Placebo single dose administered subcutaneously

Timeline

• Start date: 2018-05-23
• Primary completion: 2018-11-22
• Completion: 2018-11-22
• First posted: 2019-11-19
• Last updated: 2025-02-28

Locations

1 site across 1 country: China