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

Akeso

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy Subjects (HS)

Treatments: Drug: Ebronucimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06641388

AK102-102

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups

Ebronucimab 150mg (after the change)

Experimental group

Description:

Ebronucimab 150mg Single subcutaneous injection into the abdomen.

Treatment:

Drug: Ebronucimab

Drug: Ebronucimab

Ebronucimab 150mg (before the change)

Experimental group

Description:

Ebronucimab 150mg Single subcutaneous injection into the abdomen.

Treatment:

Drug: Ebronucimab

Drug: Ebronucimab