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

NCT ID: NCT07043283

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2026-04-30

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.

Conditions

Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ebronucimab 150mg (after the change)

Ebronucimab 150mg Single subcutaneous injection into the abdomen.

Group Type: EXPERIMENTAL

Ebronucimab

Intervention Type: DRUG

Ebronucimab subcutaneous injection.

Ebronucimab 150mg (before the change)

Ebronucimab 150mg Single subcutaneous injection into the abdomen.

Group Type: EXPERIMENTAL

Ebronucimab

Intervention Type: DRUG

Ebronucimab subcutaneous injection.

Interventions

Ebronucimab

Ebronucimab subcutaneous injection.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Akeso

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhejiang Xiaoshan Hospital

Hangzhou, Zhejiang, China

Countries

China

Central Contacts

Guoqin Wang

Role: CONTACT

global.trials@akesobio.com

86 (0760) 8987 3999

Other Identifiers

AK102-103

Identifier Type: -

Identifier Source: org_study_id