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A Study of PCSK9 Inhibitor AK102 in Healthy Subjects

NCT04169386 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-02-28

No results posted yet for this study

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

Interventions

DRUG

AK102

AK102 single dose administered subcutaneously

DRUG

Placebo

Placebo single dose administered subcutaneously

Sponsors & Collaborators

  • AD Pharmaceuticals Co., Ltd.

    collaborator INDUSTRY

  • Akeso

    lead INDUSTRY

Principal Investigators

  • Rui Chen, MD · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-23
Primary Completion
2018-11-22
Completion
2018-11-22

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04169386 on ClinicalTrials.gov