Healthy SubjectsPhase 1NCT07043283
A Study Evaluating the Single Subcutaneous Injection of Ebronucimab in Healthy Male Chinese Subjects
A Phase 1 study testing Ebronucimab in people with Healthy Subjects, run by Akeso at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Ebronucimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2025to 7 Feb 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study Evaluating the Single Subcutaneous Injection of Ebronucimab With Different Production Processes in Healthy Male Chinese Subjects
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.
Read the detailed description
This is a randomized, double-blind, 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. A total of approximately 230 Chinese healthy male subjects are planned to be enrolled.
- Conditions
- Healthy Subjects
- Being tested
- Ebronucimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EbronucimabDrug
Ebronucimab subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| Ebronucimab 150mg (after the change) | Experimental | Ebronucimab 150mg Single subcutaneous injection into the abdomen. Receives: Drug: Ebronucimab |
| Ebronucimab 150mg (before the change) | Experimental | Ebronucimab 150mg Single subcutaneous injection into the abdomen. Receives: Drug: Ebronucimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum (peak) plasma concentration (Cmax)
Assess the Cmax of Ebronucimab.
Measured: Baseline till last follow-up visit (up to day 43)
Area under curve (AUC)
Assess the AUC of Ebronucimab.
Measured: Baseline till last follow-up visit (up to day 43)
Secondary outcomes (4)
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.
Measured: After the first administration till last follow-up visit (up to day 43)
Immunogenicity index
Number and percentage of subjects with detectable anti drug antibodies (ADA) and neutralizing antibodies (Nab) after treatment.
Measured: Baseline till last follow-up visit (up to day 43)
Proprotein convertase subtilisin/kexin type 9 (PCSK-9) concentration
Percentage change in PCSK-9 concentration compared to baseline.
Measured: Baseline till last follow-up visit (up to day 43)
Serum low-density lipoprotein cholesterol (LDL-C) concentration
The change value and percentage of serum LDL-C concentration compared to baseline.
Measured: Baseline till last follow-up visit (up to day 43)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start20 Oct 2025
- Primary completion7 Feb 2026
- Study completion7 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by AkesoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07043283
- Sponsor's protocol ID
- AK102-103
- Status last verified
- Jun 2026
- First submitted
- 20 Jun 2025
- Last updated
- 26 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study Evaluating the Single Subcutaneous Injection of Ebronucimab With Different Production Processes in Healthy Male Chinese Subjects
- ClinicalTrials.gov ID
- NCT07043283
- Acronym / sponsor ID
- AK102-103
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- 7 Feb 2026 (actual)
- Study completion
- 7 Feb 2026 (actual)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, double-blind, 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. A total of approximately 230 Chinese healthy male subjects are planned to be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ebronucimab 150mg (after the change) | Experimental | Drug: EbronucimabEbronucimab 150mg Single subcutaneous injection into the abdomen. |
| Ebronucimab 150mg (before the change) | Experimental | Drug: EbronucimabEbronucimab 150mg Single subcutaneous injection into the abdomen. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EbronucimabEbronucimab subcutaneous injection. | Drug | Ebronucimab 150mg (after the change), Ebronucimab 150mg (before the change) |
Primary outcome
Maximum (peak) plasma concentration (Cmax)
Time frame: Baseline till last follow-up visit (up to day 43)
Assess the Cmax of Ebronucimab.
Area under curve (AUC)
Time frame: Baseline till last follow-up visit (up to day 43)
Assess the AUC of Ebronucimab.
4 secondary outcomes
Incidence of adverse events (AE)
Time frame: After the first administration till last follow-up visit (up to day 43)
Immunogenicity index
Time frame: Baseline till last follow-up visit (up to day 43)
Proprotein convertase subtilisin/kexin type 9 (PCSK-9) concentration
Time frame: Baseline till last follow-up visit (up to day 43)
Serum low-density lipoprotein cholesterol (LDL-C) concentration
Time frame: Baseline till last follow-up visit (up to day 43)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ebronucimab in people with Healthy Subjects, run by Akeso at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum (peak) plasma concentration (Cmax) (time frame: Baseline till last follow-up visit (up to day 43)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.