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

NCT07043283 | Not Yet Recruiting Phase 1

• 1 other identifier: AK102-103
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (2)

• Maximum (peak) plasma concentration (Cmax)

  Assess the Cmax of Ebronucimab.

  Baseline till last follow-up visit (up to day 43 or day 57)

• Area under curve (AUC)

  Assess the AUC of Ebronucimab.

  Baseline till last follow-up visit (up to day 43 or day 57)

Secondary Outcomes (4)

• Incidence of adverse events (AE)

  After the first administration till last follow-up visit (up to day 43 or day 57)

• Immunogenicity index

  Day 1 and 43 ( or Day 57)

• Proprotein convertase subtilisin/kexin type 9 (PCSK-9) concentration

  Day 1 and 43 ( or Day 57)

• Serum low-density lipoprotein cholesterol (LDL-C) concentration

  Day 1 and 43 ( or Day 57)

Study Arms (2)

Ebronucimab 150mg (after the change)

EXPERIMENTAL

Ebronucimab 150mg Single subcutaneous injection into the abdomen.

Drug: Ebronucimab

Ebronucimab 150mg (before the change)

EXPERIMENTAL

Ebronucimab 150mg Single subcutaneous injection into the abdomen.

Drug: Ebronucimab

Interventions

Ebronucimab DRUG

Ebronucimab subcutaneous injection.

Ebronucimab 150mg (after the change); Ebronucimab 150mg (before the change)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akeso: lead

Study Sites (1)

Zhejiang Xiaoshan Hospital

Hangzhou, Zhejiang, China

Location

Central Study Contacts

Guoqin Wang

CONTACT

86 (0760) 8987 3999; global.trials@akesobio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: June 29, 2025
• Study Start: July 1, 2025
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)