A Study Evaluating the Single Subcutaneous Injection of Ebronucimab in Healthy Male Chinese 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 Healthy Male Chinese Subjects
- Official title
- A Phase I Study Evaluating the Single Subcutaneous Injection of Ebronucimab With Different Production Processes in Healthy Male Chinese Subjects
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2026-02-07
- First posted
- 2025-06-29
- Registry last updated
- 2026-06-26
- Primary completion date
- 2026-02-07
- Start date
- 2025-10-20
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Akeso
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07043283
- ClinicalTrials.gov ID
- NCT07043283
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Double masking
- Masked roles
- Participants, Investigators
Maximum (peak) plasma concentration (Cmax)
Timeframe: Baseline till last follow-up visit (up to day 43)
Assess the Cmax of Ebronucimab.
Area under curve (AUC)
Timeframe: Baseline till last follow-up visit (up to day 43)
Assess the AUC of Ebronucimab.
Incidence of adverse events (AE)
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: Baseline till last follow-up visit (up to day 43)
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
- 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.
- 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.
- Zhejiang Xiaoshan HospitalHangzhou, China