Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Ebronucimab

    Drug

    Ebronucimab subcutaneous injection

  • Ebronucimab

    Drug

    Ebronucimab subcutaneous injection

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Ebronucimab 150mg (after the change)Experimental treatment 1 intervention
Group B: Ebronucimab 150mg (before the change)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Area under curve (AUC)

Assess the AUC of Ebronucimab

Time frame
Baseline till last follow-up visit( up to day 43 or day 57)
2

Maximum (peak) plasma concentration (Cmax)

Assess the Cmax of Ebronucimab

Time frame
Baseline till last follow-up visit( up to day 43 or day 57)
3

Incidence of adverse events(AE)

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.

Time frame
From the time of signing the informed consent form till last follow-up visit( up to day 43 or day 57)

Secondary outcomes

1

Free protein convertase of proprotein convertase subtilisin/kexin type 9 (PCSK-9)

Concentration and percentage change from baseline of free protein convertase PCSK-9

Time frame
Baseline till last follow-up visit( up to day 43)
2

Immunogenicity index

Number and percentage of subjects with detectable anti drug antibodies (ADA) and neutralizing antibodies (Nab) after treatment.

Time frame
Day 1 and Day 57
3

PCSK-9 concentration

Percentage change in PCSK-9 concentration compared to baseline

Time frame
Day 1 and Day 57
4

Serum Low-density lipoprotein Cholesterol (LDL-C) concentration

The change value and percentage of serum LDL-C concentration compared to baseline

Time frame
Day 1 and Day 57

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Akeso

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: