Healthy Subjects
Conditions
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, 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. A total of approximately 230 Chinese healthy male subjects are planned to be enrolled.
Interventions
DRUGEbronucimab
Ebronucimab subcutaneous injection.
Sponsors
Akeso
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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\~72kg; 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum (peak) plasma concentration (Cmax) | Baseline till last follow-up visit (up to day 43) | Assess the Cmax of Ebronucimab. |
| Area under curve (AUC) | Baseline till last follow-up visit (up to day 43) | Assess the AUC of Ebronucimab. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events (AE) | After the first administration till last follow-up visit (up to day 43) | 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. |
| Immunogenicity index | Baseline till last follow-up visit (up to day 43) | Number and percentage of subjects with detectable anti drug antibodies (ADA) and neutralizing antibodies (Nab) after treatment. |
| Proprotein convertase subtilisin/kexin type 9 (PCSK-9) concentration | Baseline till last follow-up visit (up to day 43) | Percentage change in PCSK-9 concentration compared to baseline. |
| Serum low-density lipoprotein cholesterol (LDL-C) concentration | Baseline till last follow-up visit (up to day 43) | The change value and percentage of serum LDL-C concentration compared to baseline. |
Countries
China
Outcome results
None listed