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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04169386

Enrollment

Registered

2019-11-19

Start date

2018-05-23

Completion date

2018-11-22

Last updated

2025-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolaemia

Brief 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.

Interventions

DRUGPlacebo

Placebo single dose administered subcutaneously

DRUGAK102

AK102 single dose administered subcutaneously

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
Incidence of treatment emergent AE	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

Measure	Time frame	Description
Pharmacokinetic characteristics of AK102	over 12 weeks	Serum concentrations of AK102 at different timepoints before and after AK102 single dose.
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)	At different time points from baseline through 12 weeks	Low-Density Lipoprotein Cholesterol (LDL-C) blood concentrations before and after AK102 single dose.
Percent Change From Baseline in PCSK9	At different time points from baseline through 12 weeks	PCSK9 blood concentrations before and after AK102 single dose.
Number of subjects who develop detectable anti-drug antibodies (ADAs)	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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026