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

NCT06641388 | Not Yet Recruiting Phase 1

• 1 other identifier: AK102-102
• Study Type: interventional
• Target: 180
• 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 (HS)

Keywords

phase I; healthy subjects

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Free protein convertase of proprotein convertase subtilisin/kexin type 9 (PCSK-9)

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

• Immunogenicity index

  Day 1 and Day 57

• PCSK-9 concentration

  Day 1 and Day 57

• Serum Low-density lipoprotein Cholesterol (LDL-C) concentration

  Day 1 and 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)

Eligibility Criteria

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

You may qualify if:

• 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.

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.
• Drug abuse prior to screening.

Sponsors & Collaborators

• Akeso: lead

Study Sites (1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 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: October 12, 2024
• First Posted: October 15, 2024
• Study Start: November 4, 2024
• Primary Completion: April 30, 2025
• Study Completion: June 17, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)