> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-evaluating-the-single-subcutaneous-injection-of-ac1f6431-4a7b-443d-a940-20a20061b042 > Record changed: 2026-11-04 # A Study Evaluating the Single Subcutaneous Injection of Ebronucimab in Healthy Male Chinese Subjects NCT07043283 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07043283) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07043283) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07043283) Participants 230 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07043283) Lead sponsor Akeso Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07043283) Start date 2025-10-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07043283) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07043283) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07043283) **Short title** A Study Evaluating the Single Subcutaneous Injection of Ebronucimab in Healthy Male Chinese Subjects Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07043283) **Official title** A Phase I Study Evaluating the Single Subcutaneous Injection of Ebronucimab With Different Production Processes in Healthy Male Chinese Subjects Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07043283) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07043283) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07043283) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07043283) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07043283) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07043283) ## Dates **Completion date** 2026-02-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07043283) **First posted** 2025-06-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07043283) **Registry last updated** 2026-06-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07043283) **Primary completion date** 2026-02-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07043283) **Start date** 2025-10-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07043283) ## Size and sites **Actual participants** 230 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07043283) **Participants** 230 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07043283) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07043283) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07043283) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07043283) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07043283) **Lead sponsor** Akeso Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07043283) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07043283) ## Identifiers **Registry ID** NCT07043283 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07043283) **ClinicalTrials.gov ID** NCT07043283 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07043283) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07043283) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07043283) ## Outcomes ### Primary outcomes 1. Maximum (peak) plasma concentration (Cmax) Timeframe: Baseline till last follow-up visit (up to day 43) Assess the Cmax of Ebronucimab. 2. Area under curve (AUC) Timeframe: Baseline till last follow-up visit (up to day 43) Assess the AUC of Ebronucimab. ### Secondary outcomes 1. 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. 2. 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. 3. 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. 4. 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. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07043283) ## Eligibility **Sex** Male **Age groups** Adults **Minimum age** 18 Years **Maximum age** 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07043283) ## Sites - Zhejiang Xiaoshan HospitalHangzhou, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07043283) ## Related records ### Drugs (1) - [Ebronucimab](https://trialight.com/data/asset/ebronucimab-0bbd097b-5033-5d96-8d7d-7de664a2fca9.md) ### Lead sponsors (1) - [Akeso](https://trialight.com/data/company/akeso-7431fe55-b110-4314-a667-5e8a9af91fc3.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. Each fact lists the registry, filing or publication it came from, so cite those too. - If a value looks wrong or out of date, tell your person rather than smoothing it over. 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