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Completed

NCT Number: NCT04169386

A Study of PCSK9 Inhibitor 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.

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Key information

Conditions

Hypercholesterolaemia Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peking Union Medical College Hospital

Beijing, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

AK102

Drug

AK102 single dose administered subcutaneously

Placebo

Drug

Placebo single dose administered subcutaneously

Primary outcomes

  1. Incidence of treatment emergent AE

    Time frame: From single dose of AK102 through 12 weeks

    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.

Secondary outcomes

  1. Pharmacokinetic characteristics of AK102

    Time frame: over 12 weeks

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

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

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

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

  3. Percent Change From Baseline in PCSK9

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

    PCSK9 blood concentrations before and after AK102 single dose.

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

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

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

Sponsors and collaborators

Lead sponsor

Akeso

Industry

Collaborators

  • AD Pharmaceuticals Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 19, 2019
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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