A Study of PCSK9 Inhibitor AK102 in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-23

Study Completion Date

2018-11-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypercholesterolaemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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AK102 75mg

Group Type EXPERIMENTAL

AK102

Intervention Type DRUG

AK102 single dose administered subcutaneously

AK102 150mg

Group Type EXPERIMENTAL

AK102

Intervention Type DRUG

AK102 single dose administered subcutaneously

AK102 300mg

Group Type EXPERIMENTAL

AK102

Intervention Type DRUG

AK102 single dose administered subcutaneously

AK102 500mg

Group Type EXPERIMENTAL

AK102

Intervention Type DRUG

AK102 single dose administered subcutaneously

Placebo

Matching placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo single dose administered subcutaneously

Interventions

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AK102

AK102 single dose administered subcutaneously

Intervention Type DRUG

Placebo

Placebo single dose administered subcutaneously

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes