A Study of PCSK9 Inhibitor AK102 in Healthy Subjects

Akeso

Status and phase: Completed; Phase 1

Conditions: Hypercholesterolaemia

Treatments: Drug: AK102; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04169386

AK102-101

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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32 participants in 5 patient groups, including a placebo group

AK102 75mg

Experimental group

Description:

AK102 75mg

Treatment:

Drug: AK102

AK102 150mg

Experimental group

Description:

AK102 150mg

Treatment:

Drug: AK102

AK102 300mg

Experimental group

Description:

AK102 300mg

Treatment:

Drug: AK102

AK102 500mg

Experimental group

Description:

AK102 500mg

Treatment:

Drug: AK102

Placebo

Placebo Comparator group

Description:

Matching placebo

Treatment:

Drug: Placebo