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

Akeso

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Ebronucimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT07043283

AK102-103

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, 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.

Enrollment: 204 estimated patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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204 participants in 2 patient groups

Ebronucimab 150mg (after the change)

Experimental group

Description:

Ebronucimab 150mg Single subcutaneous injection into the abdomen.

Treatment:

Drug: Ebronucimab

Ebronucimab 150mg (before the change)

Experimental group

Description:

Ebronucimab 150mg Single subcutaneous injection into the abdomen.

Treatment:

Drug: Ebronucimab