Healthy Subjects (HS)Phase 1NCT06641388
A Study Evaluating the Single Subcutaneous Injection of Ebronucimab in Chinese Healthy Male Subjects
A Phase 1 study testing Ebronucimab in people with Healthy Subjects (HS), 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 (HS)
- 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
- 180 participants
- Where
- 1 siteChina
- Study dates
- 4 Nov 2024to 17 Jun 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- 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.
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.
- Drug abuse prior to screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Third Xiangya Hospital of Central South University
Changsha, Hunan
About this study
Official title: A Phase I Study Evaluating the Single Subcutaneous Injection of Ebronucimab With Different Production Processes in Chinese Healthy Male 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, 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.
- Conditions
- Healthy Subjects (HS)
- Being tested
- Ebronucimab
- Keywords
- phase I, healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EbronucimabDrug
Ebronucimab subcutaneous injection
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.
Area under curve (AUC)
Assess the AUC of Ebronucimab
Measured: Baseline till last follow-up visit( up to day 43 or day 57)
Maximum (peak) plasma concentration (Cmax)
Assess the Cmax of Ebronucimab
Measured: Baseline till last follow-up visit( up to day 43 or day 57)
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: From the time of signing the informed consent form till last follow-up visit( up to day 43 or day 57)
Secondary outcomes (4)
Free protein convertase of proprotein convertase subtilisin/kexin type 9 (PCSK-9)
Concentration and percentage change from baseline of free protein convertase PCSK-9
Measured: Baseline 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: Day 1 and Day 57
PCSK-9 concentration
Percentage change in PCSK-9 concentration compared to baseline
Measured: Day 1 and Day 57
Serum Low-density lipoprotein Cholesterol (LDL-C) concentration
The change value and percentage of serum LDL-C concentration compared to baseline
Measured: Day 1 and Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start4 Nov 2024 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion17 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Subjects (HS)Studies 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
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641388
- Sponsor's protocol ID
- AK102-102
- Status last verified
- Oct 2024
- First submitted
- 12 Oct 2024
- Last updated
- 15 Oct 2024
- 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 15 Oct 2024. 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 Chinese Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT06641388
- Acronym / sponsor ID
- AK102-102
- Conditions
- Healthy Subjects (HS)
- Keywords
- phase I, healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2024 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 17 Jun 2025 (estimated)
- First posted
- 15 Oct 2024 (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, 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.
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 (4 listed)
- 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 (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.
- Drug abuse prior to screening.
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) |
| EbronucimabEbronucimab subcutaneous injection | Drug | Ebronucimab 150mg (before the change) |
Primary outcome
Area under curve (AUC)
Time frame: Baseline till last follow-up visit( up to day 43 or day 57)
Assess the AUC of Ebronucimab
Maximum (peak) plasma concentration (Cmax)
Time frame: Baseline till last follow-up visit( up to day 43 or day 57)
Assess the Cmax of Ebronucimab
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)
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Healthy Subjects (HS)
Recruiting
Methodological Study of Exercise and Hypoxic Conditions in Healthy Subjects
Healthy Subjects (HS), Exercise
Recruiting
Reactive Balance Training in Augmented Reality for Older Adults
Healthy Subjects (HS)
Active, not recruitingObservational study
Exploring the Olfactory Mucosa, Blood and Urine for the Identification of Early Biomarkers of Parkinson's Disease, Atypical Parkinsonisms and Neurocognitive Disorders Due to Lewy Body Disease
Parkinson Disease, MSA - Multiple System Atrophy
Recruiting
Self-initiated Perturbation-based Training in Older Adults
Healthy Subjects (HS)
Not yet recruiting
Effect of Continuous Nebulisation of Isotonic Saline Solution Combined With Heated Humidification on Mucociliary Clearance in Healthy Subjects
Healthy Subjects (HS)
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.
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 (HS), 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 4 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: opening soon, as of the sponsor's last update on 15 Oct 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guoqin Wang (+86 (0760) 8987 3999, global.trials@akesobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under curve (AUC) (time frame: Baseline till last follow-up visit( up to day 43 or day 57)). The study lists 3 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 15 Oct 2024.