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

Not Applicable

Not yet recruiting

• Conditions: Healthy Subjects
• Interventions: Drug: Ebronucimab

• Registration Number: NCT07043283
• Lead Sponsor: Akeso

Brief Summary

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.

Detailed Description

This is a randomized, double-blind, 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 sample size of 36 subjects in the pre-trial part, and 168 subjects in the formal trial part. A total of approximately 204 Chinese healthy male subjects are planned to be enrolled.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-20
• Study First Submitted QC: 2025-06-20
• Last Update Submitted: 2025-06-20
• Study First Posted: 2025-06-29
• Last Update Posted: 2025-06-29
• Study Start: 2025-07-01
• Primary Completion: 2026-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 204

Inclusion Criteria

• 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.
• Weight: 60~80kg; Body mass index (BMI) ≥ 19 and ≤ 26 kg /m² for healthy Chinese male subjects.
• Fasting LDL-C level<4.1mmol/L.
• Fasting triglycerides<3.42mmol/L.
• Required to voluntarily adopt effective contraceptive measures as specified in the protocol throughout the entire trial period and within 3 months after receiving the investigational product, and avoid sperm donation.

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.
• Investigators believe that other factors may disqualify individuals from participating in the trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ebronucimab 150mg (before the change)	Ebronucimab	Ebronucimab 150mg Single subcutaneous injection into the abdomen.
Ebronucimab 150mg (after the change)	Ebronucimab	Ebronucimab 150mg Single subcutaneous injection into the abdomen.

Primary Outcome Measures

Name	Time	Method
Maximum (peak) plasma concentration (Cmax)	Baseline till last follow-up visit (up to day 43 or day 57)	Assess the Cmax of Ebronucimab.
Area under curve (AUC)	Baseline till last follow-up visit (up to day 43 or day 57)	Assess the AUC of Ebronucimab.

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events (AE)	After the first administration till last follow-up visit (up to day 43 or day 57)	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.
Immunogenicity index	Day 1 and 43 ( or Day 57)	Number and percentage of subjects with detectable anti drug antibodies (ADA) and neutralizing antibodies (Nab) after treatment.
Proprotein convertase subtilisin/kexin type 9 (PCSK-9) concentration	Day 1 and 43 ( or Day 57)	Percentage change in PCSK-9 concentration compared to baseline.
Serum low-density lipoprotein cholesterol (LDL-C) concentration	Day 1 and 43 ( or Day 57)	The change value and percentage of serum LDL-C concentration compared to baseline.