A Study of PCSK9 Inhibitor AK102 in Healthy Subjects

NCT04169386 | Completed Phase 1 DMC

• 1 other identifier: AK102-101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercholesterolaemia

Outcome Measures

Primary Outcomes (1)

• 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.

  From single dose of AK102 through 12 weeks

Secondary Outcomes (4)

• Pharmacokinetic characteristics of AK102

  over 12 weeks

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

  At different time points from baseline through 12 weeks

• Percent Change From Baseline in PCSK9

  At different time points from baseline through 12 weeks

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

  At different time points from baseline through 12 weeks

Study Arms (5)

AK102 75mg

EXPERIMENTAL

AK102 75mg

Drug: AK102

AK102 150mg

EXPERIMENTAL

AK102 150mg

Drug: AK102

AK102 300mg

EXPERIMENTAL

AK102 300mg

Drug: AK102

AK102 500mg

EXPERIMENTAL

AK102 500mg

Drug: AK102

Placebo

PLACEBO COMPARATOR

Matching placebo

Drug: Placebo

Interventions

AK102 DRUG

AK102 single dose administered subcutaneously

AK102 150mg; AK102 300mg; AK102 500mg; AK102 75mg

Placebo DRUG

Placebo single dose administered subcutaneously

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Akeso: lead
• AD Pharmaceuticals Co., Ltd.: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Rui Chen, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2019
• First Posted: November 19, 2019
• Study Start: May 23, 2018
• Primary Completion: November 22, 2018
• Study Completion: November 22, 2018
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)