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A Study of PCSK9 Inhibitor AK102 in Healthy Subjects

Primary Purpose

Hypercholesterolaemia

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

AK102

Placebo

About this trial

This is an interventional treatment trial for Hypercholesterolaemia

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts 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)

Sites / Locations

Peking Union Medical College Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Arm Label

AK102 75mg

AK102 150mg

AK102 300mg

AK102 500mg

Placebo

Arm Description

AK102 75mg

AK102 150mg

AK102 300mg

AK102 500mg

Matching placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Pharmacokinetic characteristics of AK102

Serum concentrations of AK102 at different timepoints before and after AK102 single dose.

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

Low-Density Lipoprotein Cholesterol (LDL-C) blood concentrations before and after AK102 single dose.

Percent Change From Baseline in PCSK9

PCSK9 blood concentrations before and after AK102 single dose.

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

The immunogenicity of AK102 will be assessed by summarizing the number of subjects who develop detectable ADAs.

Full Information

NCT ID

NCT04169386

First Posted

November 17, 2019

Last Updated

November 17, 2019

Sponsor

Akeso

Collaborators

AD Pharmaceuticals Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04169386

Brief Title

A Study of PCSK9 Inhibitor AK102 in Healthy Subjects

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

May 9, 2018 (Actual)

Primary Completion Date

November 28, 2018 (Actual)

Study Completion Date

June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Akeso

Collaborators

AD Pharmaceuticals Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercholesterolaemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AK102 75mg

Arm Type

Experimental

Arm Description

AK102 75mg

Arm Title

AK102 150mg

Arm Type

Experimental

Arm Description

AK102 150mg

Arm Title

AK102 300mg

Arm Type

Experimental

Arm Description

AK102 300mg

Arm Title

AK102 500mg

Arm Type

Experimental

Arm Description

AK102 500mg

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Matching placebo

Intervention Type

Drug

Intervention Name(s)

AK102

Intervention Description

AK102 single dose administered subcutaneously

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo single dose administered subcutaneously

Primary Outcome Measure Information:

Title

Incidence of treatment emergent AE

Description

Time Frame

From single dose of AK102 through 12 weeks

Secondary Outcome Measure Information:

Title

Pharmacokinetic characteristics of AK102

Description

Serum concentrations of AK102 at different timepoints before and after AK102 single dose.

Time Frame

over 12 weeks

Title

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

Description

Low-Density Lipoprotein Cholesterol (LDL-C) blood concentrations before and after AK102 single dose.

Time Frame

At different time points from baseline through 12 weeks

Title

Percent Change From Baseline in PCSK9

Description

PCSK9 blood concentrations before and after AK102 single dose.

Time Frame

At different time points from baseline through 12 weeks

Title

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

Description

The immunogenicity of AK102 will be assessed by summarizing the number of subjects who develop detectable ADAs.

Time Frame

At different time points from baseline through 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rui Chen, MD

Organizational Affiliation

Peking Union Medical College Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peking Union Medical College Hospital

City

Peking

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Study of PCSK9 Inhibitor AK102 in Healthy Subjects

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