A Study of PCSK9 Inhibitor AK102 in Healthy Subjects

Hypercholesterolaemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04169386
• Other study ID #: AK102-101
• Status: Completed
• Phase: Phase 1
• Start date: May 9, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: November 2019
• Source: Akeso
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 30, 2019
• Est. primary completion date: November 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hypercholesterolaemia
• Hypercholesterolemia

Intervention

Drug:
• AK102
AK102 single dose administered subcutaneously
• Placebo
Placebo single dose administered subcutaneously

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Peking

Sponsors (2)

Lead Sponsor	Collaborator
Akeso	AD Pharmaceuticals Co., Ltd. (Guangzhou)

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pharmacokinetic characteristics of AK102	Serum concentrations of AK102 at different timepoints before and after AK102 single dose.	over 12 weeks
Secondary	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.	At different time points from baseline through 12 weeks
Secondary	Percent Change From Baseline in PCSK9	PCSK9 blood concentrations before and after AK102 single dose.	At different time points from baseline through 12 weeks
Secondary	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.	At different time points from baseline through 12 weeks