A Study Evaluating the Single Subcutaneous Injection of Ebronucimab in Chinese Healthy Male Subjects
- 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.
- Short title
- 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
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Not yet recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2025-06-17
- First posted
- 2024-10-15
- Registry last updated
- 2024-10-15
- Primary completion date
- 2025-04-30
- Start date
- 2024-11-04
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Akeso
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06641388
- ClinicalTrials.gov ID
- NCT06641388
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Double masking
- Masked roles
- Participants, Investigators
Area under curve (AUC)
Timeframe: Baseline till last follow-up visit( up to day 43 or day 57)
Assess the AUC of Ebronucimab
Maximum (peak) plasma concentration (Cmax)
Timeframe: Baseline till last follow-up visit( up to day 43 or day 57)
Assess the Cmax of Ebronucimab
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)
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.
Free protein convertase of proprotein convertase subtilisin/kexin type 9 (PCSK-9)
Timeframe: Baseline till last follow-up visit( up to day 43)
Concentration and percentage change from baseline of free protein convertase PCSK-9
Immunogenicity index
Timeframe: 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
Timeframe: Day 1 and Day 57
Percentage change in PCSK-9 concentration compared to baseline
Serum Low-density lipoprotein Cholesterol (LDL-C) concentration
Timeframe: Day 1 and Day 57
The change value and percentage of serum LDL-C concentration compared to baseline
- Sex
- Male
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 45 Years
- Healthy volunteers
- Yes
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.
- The Third Xiangya Hospital of Central South UniversityChangsha, China