A Study Evaluating the Single Subcutaneous Injection of Ebronucimab in Chinese Healthy Male Subjects

A Phase I Study Evaluating the Single Subcutaneous Injection of Ebronucimab With Different Production Processes in Chinese Healthy Male Subjects

This is a phase I clinical study to evaluate the pharmacokinetics (PK) similarity of single dose subcutaneous injection of Ebronucimab with different production processes in Chinese healthy male subjects.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Subjects (HS)
• Intervention / Treatment: Drug: Ebronucimab

Detailed Description

This is a randomized, parallel controlled, phase I clinical study to evaluate the pharmacokinetics (PK) similarity of single dose subcutaneous injection of Ebronucimab with different production processes in Chinese healthy male subjects. This study consists of two parts: pre-trial part and formal-trial part, with a planned enrollment of approximately 180 healthy male participants from China.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Guoqin Wang; Phone Number: +86 (0760) 8987 3999; Email: global.trials@akesobio.com

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China
      • The Third Xiangya Hospital of Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Key Inclusion Criteria:

• Weight: 60~80kg; Body mass index (BMI) ≥ 19 and ≤ 26 kg /m2 for healthy Chinese male subjects.
• Subjects fully understand the purpose, content, process, and potential adverse events of the trial, voluntarily participate in the trial, and sign an informed consent form before any trial procedure begins.
• Low density lipoprotein cholesterol (LDL-C) levels ≥ 1.8mmol/L and ≤ 4.9mmol/L during screening.
• Subjects are able to communicate well with the investigator and understand the requirements of the study.

Key Exclusion Criteria:

• 12 months prior use of PCSK9 inhibitors treatment.
• Allergic to the components of Ebronucimab and any monoclonal antibodies.
• History of important organ transplantation (such as heart, lung, liver, kidney, etc.).
• Abnormal vital signs during screening period and before randomization.
• Drug abuse prior to screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ebronucimab 150mg (after the change); Ebronucimab 150mg Single subcutaneous injection into the abdomen.	Drug: Ebronucimab; Ebronucimab subcutaneous injection
Experimental: Ebronucimab 150mg (before the change); Ebronucimab 150mg Single subcutaneous injection into the abdomen.	Drug: Ebronucimab; Ebronucimab subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under curve (AUC)	Assess the AUC of Ebronucimab	Baseline till last follow-up visit( up to day 43 or day 57)
Maximum (peak) plasma concentration (Cmax)	Assess the Cmax of Ebronucimab	Baseline till last follow-up visit( up to day 43 or day 57)
Incidence of adverse events(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 the time of signing the informed consent form till last follow-up visit( up to day 43 or day 57)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Free protein convertase of proprotein convertase subtilisin/kexin type 9 (PCSK-9)	Concentration and percentage change from baseline of free protein convertase PCSK-9	Baseline till last follow-up visit( up to day 43)
Immunogenicity index	Number and percentage of subjects with detectable anti drug antibodies (ADA) and neutralizing antibodies (Nab) after treatment.	Day 1 and Day 57
PCSK-9 concentration	Percentage change in PCSK-9 concentration compared to baseline	Day 1 and Day 57
Serum Low-density lipoprotein Cholesterol (LDL-C) concentration	The change value and percentage of serum LDL-C concentration compared to baseline	Day 1 and Day 57

Collaborators and Investigators

• Sponsor: Akeso

Study record dates

Study Major Dates

• Study Start (Estimated): November 4, 2024
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): June 17, 2025

Study Registration Dates

• First Submitted: October 12, 2024
• First Submitted That Met QC Criteria: October 12, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 12, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: healthy subjects; phase I
• Other Study ID Numbers: AK102-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No