Clinical trial NCT06641388: A Study Evaluating the Single Subcutaneous Injection of Ebronucimab in Chinese Healthy Male Subjects
Official title: A Phase I Study Evaluating the Single Subcutaneous Injection of Ebronucimab With Different Production Processes in Chinese Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Healthy Subjects (HS)
Keywords: phase I
healthy subjects
Lead sponsor: Akeso
Sponsor class: INDUSTRY
First posted: 2024-10-15
Enrollment: 180
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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, 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.

Eligibility 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.

Primary outcomes:
measure: Area under curve (AUC)
timeFrame: Baseline till last follow-up visit( up to day 43 or day 57)
measure: Maximum (peak) plasma concentration (Cmax)
timeFrame: Baseline till last follow-up visit( up to day 43 or day 57)
measure: Incidence of adverse events(AE)
timeFrame: From the time of signing the informed consent form till last follow-up visit( up to day 43 or day 57)
Secondary outcomes:
measure: Free protein convertase of proprotein convertase subtilisin/kexin type 9 (PCSK-9)
timeFrame: Baseline till last follow-up visit( up to day 43)
measure: Immunogenicity index
timeFrame: Day 1 and Day 57
measure: PCSK-9 concentration
timeFrame: Day 1 and Day 57
measure: Serum Low-density lipoprotein Cholesterol (LDL-C) concentration
timeFrame: Day 1 and Day 57
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
Study officials:
References: