A Study of PCSK9 Inhibitor AK102 in Healthy Subjects

• Status: Completed
• Trial end date: 2019-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Akeso
• Collaborators: AD Pharmaceuticals Co., Ltd.; AD Pharmaceuticals Co., Ltd. (Guangzhou)

Criteria

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)