A Study of PCSK9 Inhibitor AK102 in Healthy Subjects

Akeso32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Hypercholesterolaemia

Interventions

AK102DRUG

AK102 single dose administered subcutaneously

PlaceboDRUG

Placebo single dose administered subcutaneously

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Peking Union Medical College Hospital

Beijing, China

Outcomes

Primary Outcomes

Incidence of treatment emergent AE

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.

Time frame: From single dose of AK102 through 12 weeks

Secondary Outcomes

Pharmacokinetic characteristics of AK102

Serum concentrations of AK102 at different timepoints before and after AK102 single dose.

Time frame: over 12 weeks

Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)

Low-Density Lipoprotein Cholesterol (LDL-C) blood concentrations before and after AK102 single dose.

Time frame: At different time points from baseline through 12 weeks

Percent Change From Baseline in PCSK9

PCSK9 blood concentrations before and after AK102 single dose.

Time frame: At different time points from baseline through 12 weeks

Number of subjects who develop detectable anti-drug antibodies (ADAs)

The immunogenicity of AK102 will be assessed by summarizing the number of subjects who develop detectable ADAs.

Time frame: At different time points from baseline through 12 weeks

Data from ClinicalTrials.gov

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