A Study Evaluating the Single Subcutaneous Injection of Ebronucimab in Chinese Healthy Male Subjects
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ebronucimab, Ebronucimab.
- Who it may be relevant to
- Registry conditions: Healthy Subjects (HS). Basic parameters: 18 years — 45 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase I Study Evaluating the Single Subcutaneous Injection of Ebronucimab With Different Production Processes in Chinese Healthy Male Subjects
Overview
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
- Drug Ebronucimab
Ebronucimab subcutaneous injection - Drug Ebronucimab
Ebronucimab subcutaneous injection
Primary outcome measures
- Area under curve (AUC) [Time frame: Baseline till last follow-up visit( up to day 43 or day 57)]
- Maximum (peak) plasma concentration (Cmax) [Time frame: Baseline till last follow-up visit( up to day 43 or day 57)]
- Incidence of adverse events(AE) [Time frame: From the time of signing the informed consent form till last follow-up visit( up to day 43 or day 57)]
Secondary outcome measures (4)
- Free protein convertase of proprotein convertase subtilisin/kexin type 9 (PCSK-9) [Time frame: Baseline till last follow-up visit( up to day 43)]
- Immunogenicity index [Time frame: Day 1 and Day 57]
- PCSK-9 concentration [Time frame: Day 1 and Day 57]
- Serum Low-density lipoprotein Cholesterol (LDL-C) concentration [Time frame: Day 1 and Day 57]
Eligibility criteria
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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Third Xiangya Hospital of Central South University — Changsha
Identifiers
NCT: NCT06641388 · AK102-102