Healthy Subjects (HS)
Conditions
Keywords
phase I, healthy subjects
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.
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under curve (AUC) | Baseline till last follow-up visit( up to day 43 or day 57) | Assess the AUC of Ebronucimab |
| Maximum (peak) plasma concentration (Cmax) | Baseline till last follow-up visit( up to day 43 or day 57) | Assess the Cmax of Ebronucimab |
| Incidence of adverse events(AE) | From the time of signing the informed consent form till last follow-up visit( up to day 43 or day 57) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Free protein convertase of proprotein convertase subtilisin/kexin type 9 (PCSK-9) | Baseline till last follow-up visit( up to day 43) | Concentration and percentage change from baseline of free protein convertase PCSK-9 |
| Serum Low-density lipoprotein Cholesterol (LDL-C) concentration | Day 1 and Day 57 | The change value and percentage of serum LDL-C concentration compared to baseline |
| Immunogenicity index | Day 1 and Day 57 | Number and percentage of subjects with detectable anti drug antibodies (ADA) and neutralizing antibodies (Nab) after treatment. |
| PCSK-9 concentration | Day 1 and Day 57 | Percentage change in PCSK-9 concentration compared to baseline |
Countries
China
Contacts
Primary ContactGuoqin Wang
Outcome results
None listed