A Study Evaluating the Single Subcutaneous Injection of Ebronucimab in Chinese Healthy Male Subjects
ConditionHealthy Subjects (HS)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-45
SponsorAkeso
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Ebronucimab
- Ebronucimab
Treatment groups
180 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov