Trial | NCT04169386  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    AK102 ...

  • Study Participants

    32
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.
Study Started
May 09
2018
Primary Completion
Nov 28
2018
Study Completion
Jun 30
2019
Last Update
Nov 19
2019

Drug AK102

AK102 single dose administered subcutaneously

Drug Placebo

Placebo single dose administered subcutaneously

AK102 75mg Experimental

AK102 75mg

AK102 150mg Experimental

AK102 150mg

AK102 300mg Experimental

AK102 300mg

AK102 500mg Experimental

AK102 500mg

Placebo Placebo Comparator

Matching placebo

Criteria 

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)
No Results Posted