A Study of PCSK9 Inhibitor AK102 in Healthy Subjects

Phase 1

Completed

• Conditions: Hypercholesterolaemia
• Interventions: Drug: AK102; Drug: Placebo

• Registration Number: NCT04169386
• Lead Sponsor: Akeso

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-23
• Primary Completion: 2018-11-22
• Study Completion: 2018-11-22
• Study First Submitted: 2019-11-17
• Study First Submitted QC: 2019-11-17
• Study First Posted: 2019-11-19
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AK102 75mg	AK102	AK102 75mg
AK102 150mg	AK102	AK102 150mg
Placebo	Placebo	Matching placebo
AK102 300mg	AK102	AK102 300mg
AK102 500mg	AK102	AK102 500mg

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Peking, China