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

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.

Inclusion Criteria:

• Signed Informed Consent.
• No clinically significant abnormalities judged by the principal investigator based on the medical history, physical examination, electrocardiogram and routine laboratory evaluations.
• Low-density lipoprotein cholesterol (LDL-C) level of 70-190 mg/dL (inclusive).
• Body mass index (BMI) ≥18 and ≤ 28 kg/m^2 , body weight >= 50 kg for male or >= 45 kg for female.

Exclusion Criteria:

• Triglyceride concentration >400 mg/dL (4.5 mmol/L).
• History of hypersensitivity reactions to any substance of the investigation drug or other monoclonal antibodies.
• Drug or alcohol abuse within 6 months prior to dosing.
• Blood pressure >140 mmHg (systolic) or > 90 mmHg (diastolic)