> 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-12e78b3f-efd8-4c0a-b832-129b957b48b2 > Record changed: 2026-11-04 # A Study Evaluating the Single Subcutaneous Injection of Ebronucimab in Chinese Healthy Male Subjects NCT06641388 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641388) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641388) Recruitment status Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641388) Participants 180 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641388) Lead sponsor Akeso Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641388) Start date 2024-11-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641388) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641388) ## 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/NCT06641388) **Short title** A Study Evaluating the Single Subcutaneous Injection of Ebronucimab in Chinese Healthy Male Subjects Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641388) **Official title** A Phase I Study Evaluating the Single Subcutaneous Injection of Ebronucimab With Different Production Processes in Chinese Healthy Male Subjects Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641388) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641388) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641388) **Recruitment status** Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641388) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641388) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641388) ## Dates **Completion date** 2025-06-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641388) **First posted** 2024-10-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641388) **Registry last updated** 2024-10-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641388) **Primary completion date** 2025-04-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641388) **Start date** 2024-11-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641388) ## Size and sites **Participants** 180 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641388) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641388) **Planned participants** 180 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641388) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641388) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641388) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641388) **Lead sponsor** Akeso Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641388) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641388) ## Identifiers **Registry ID** NCT06641388 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641388) **ClinicalTrials.gov ID** NCT06641388 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641388) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641388) ## 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/NCT06641388) ## Outcomes ### Primary outcomes 1. Area under curve (AUC) Timeframe: Baseline till last follow-up visit( up to day 43 or day 57) Assess the AUC of Ebronucimab 2. Maximum (peak) plasma concentration (Cmax) Timeframe: Baseline till last follow-up visit( up to day 43 or day 57) Assess the Cmax of Ebronucimab 3. 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. ### Secondary outcomes 1. 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 2. 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. 3. PCSK-9 concentration Timeframe: Day 1 and Day 57 Percentage change in PCSK-9 concentration compared to baseline 4. 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 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641388) ## Eligibility **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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641388) ## Sites - The Third Xiangya Hospital of Central South UniversityChangsha, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06641388) ## 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. 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