A Study of PCSK9 Inhibitor AK102 in Healthy Subjects

• Sponsor: Akeso (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04169386
• Collaborator: AD Pharmaceuticals Co., Ltd. (Industry)
• Enrollment: 32
• Location: 1
• Arms: 5
• Actual Duration (Months): 13.7
• Patients Per Site Per Month: 2.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolaemia	Drug: AK102; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 9, 2018
• Actual Primary Completion Date: Nov 28, 2018
• Actual Study Completion Date: Jun 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AK102 75mg AK102 75mg	Drug: AK102; AK102 single dose administered subcutaneously
Experimental: AK102 150mg AK102 150mg	Drug: AK102; AK102 single dose administered subcutaneously
Experimental: AK102 300mg AK102 300mg	Drug: AK102; AK102 single dose administered subcutaneously
Experimental: AK102 500mg AK102 500mg	Drug: AK102; AK102 single dose administered subcutaneously
Placebo Comparator: Placebo Matching placebo	Drug: Placebo; Placebo single dose administered subcutaneously

Outcome Measures

Primary Outcome Measures

1. Incidence of treatment emergent AE [From single dose of AK102 through 12 weeks]

   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

1. Pharmacokinetic characteristics of AK102 [over 12 weeks]

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

2. Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) [At different time points from baseline through 12 weeks]

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

3. Percent Change From Baseline in PCSK9 [At different time points from baseline through 12 weeks]

   PCSK9 blood concentrations before and after AK102 single dose.

4. Number of subjects who develop detectable anti-drug antibodies (ADAs) [At different time points from baseline through 12 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking Union Medical College Hospital	Peking		China

Sponsors and Collaborators

• Akeso
• AD Pharmaceuticals Co., Ltd.

Investigators

• Principal Investigator: Rui Chen, MD, Peking Union Medical College Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Akeso
• ClinicalTrials.gov Identifier: NCT04169386
• Other Study ID Numbers: AK102-101
• First Posted: Nov 19, 2019
• Last Update Posted: Nov 19, 2019
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypercholesterolemia

Study Results

No Results Posted as of Nov 19, 2019