HypercholesterolaemiaPhase 1NCT04169386
A Study of PCSK9 Inhibitor AK102 in Healthy Subjects
A Phase 1 study testing AK102 in people with Hypercholesterolaemia, run by Akeso at 1 site in China.
Trial summary
This is a first-in-human,randomized, double-blind, placebo-controlled, single dose escalation, phase 1 study to evaluate the safety, tolerability, PK/PD and immunogenicity of AK102 administered subcutaneously in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolaemia
- What is being tested?
- AK102
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 23 May 2018to 22 Nov 2018
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed Informed Consent.
- No clinically significant abnormalities judged by the principal investigator based on the medical history, physical examination, electrocardiogram and routine laboratory evaluations.
- Low-density lipoprotein cholesterol (LDL-C) level of 70-190 mg/dL (inclusive).
- Body mass index (BMI) ≥18 and ≤ 28 kg/m^2 , body weight >= 50 kg for male or >= 45 kg for female.
Who cannot join
- Triglyceride concentration >400 mg/dL (4.5 mmol/L).
- History of hypersensitivity reactions to any substance of the investigation drug or other monoclonal antibodies.
- Drug or alcohol abuse within 6 months prior to dosing.
- Blood pressure >140 mmHg (systolic) or > 90 mmHg (diastolic)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A First-in-Human,Randomized, Double-Blind, Placebo-Controlled, Single Dose Escalation,Phase 1 Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Pharmacodynamics of AK102 in Healthy Subjects
This is a first-in-human,randomized, double-blind, placebo-controlled, single dose escalation, phase 1 study to evaluate the safety, tolerability, PK/PD and immunogenicity of AK102 administered subcutaneously in healthy subjects. Subjects will be randomized into 4 planned single dose escalation cohorts or placebo cohort.
- Conditions
- Hypercholesterolaemia
- Being tested
- AK102, Placebo
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK102Drug
AK102 single dose administered subcutaneously
PlaceboDrug
Placebo single dose administered subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| AK102 75mg | Experimental | AK102 75mg Receives: Drug: AK102 |
| AK102 150mg | Experimental | AK102 150mg Receives: Drug: AK102 |
| AK102 300mg | Experimental | AK102 300mg Receives: Drug: AK102 |
| AK102 500mg | Experimental | AK102 500mg Receives: Drug: AK102 |
| Placebo | Placebo comparator | Matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent 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 single dose of AK102 through 12 weeks
Secondary outcomes (4)
Pharmacokinetic characteristics of AK102
Serum concentrations of AK102 at different timepoints before and after AK102 single dose.
Measured: over 12 weeks
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
Low-Density Lipoprotein Cholesterol (LDL-C) blood concentrations before and after AK102 single dose.
Measured: At different time points from baseline through 12 weeks
Percent Change From Baseline in PCSK9
PCSK9 blood concentrations before and after AK102 single dose.
Measured: At different time points from baseline through 12 weeks
Number of subjects who develop detectable anti-drug antibodies (ADAs)
The immunogenicity of AK102 will be assessed by summarizing the number of subjects who develop detectable ADAs.
Measured: At different time points from baseline through 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start23 May 2018
- Primary completion22 Nov 2018
- Study completion22 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolaemiaStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AD Pharmaceuticals Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Rui Chen, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04169386
- Sponsor's protocol ID
- AK102-101
- Status last verified
- Feb 2025
- First submitted
- 17 Nov 2019
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human,Randomized, Double-Blind, Placebo-Controlled, Single Dose Escalation,Phase 1 Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Pharmacodynamics of AK102 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04169386
- Acronym / sponsor ID
- AK102-101
- Conditions
- Hypercholesterolaemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Collaborators
- AD Pharmaceuticals Co., Ltd.
- Study start
- 23 May 2018 (actual)
- Primary completion
- 22 Nov 2018 (actual)
- Study completion
- 22 Nov 2018 (actual)
- First posted
- 19 Nov 2019 (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 first-in-human,randomized, double-blind, placebo-controlled, single dose escalation, phase 1 study to evaluate the safety, tolerability, PK/PD and immunogenicity of AK102 administered subcutaneously in healthy subjects. Subjects will be randomized into 4 planned single dose escalation cohorts or placebo cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| AK102 75mg | Experimental | Drug: AK102AK102 75mg |
| AK102 150mg | Experimental | Drug: AK102AK102 150mg |
| AK102 300mg | Experimental | Drug: AK102AK102 300mg |
| AK102 500mg | Experimental | Drug: AK102AK102 500mg |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Signed Informed Consent.
- No clinically significant abnormalities judged by the principal investigator based on the medical history, physical examination, electrocardiogram and routine laboratory evaluations.
- Low-density lipoprotein cholesterol (LDL-C) level of 70-190 mg/dL (inclusive).
- Body mass index (BMI) ≥18 and ≤ 28 kg/m^2 , body weight >= 50 kg for male or >= 45 kg for female.
Key exclusion criteria (4 listed)
- Triglyceride concentration >400 mg/dL (4.5 mmol/L).
- History of hypersensitivity reactions to any substance of the investigation drug or other monoclonal antibodies.
- Drug or alcohol abuse within 6 months prior to dosing.
- Blood pressure >140 mmHg (systolic) or > 90 mmHg (diastolic)
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 |
|---|---|---|
| AK102AK102 single dose administered subcutaneously | Drug | AK102 150mg, AK102 300mg, AK102 500mg, AK102 75mg |
| PlaceboPlacebo single dose administered subcutaneously | Drug | Placebo |
Primary outcome
Incidence of treatment emergent AE
Time frame: From single dose of AK102 through 12 weeks
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
Pharmacokinetic characteristics of AK102
Time frame: over 12 weeks
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
Time frame: At different time points from baseline through 12 weeks
Percent Change From Baseline in PCSK9
Time frame: At different time points from baseline through 12 weeks
Number of subjects who develop detectable anti-drug antibodies (ADAs)
Time frame: At different time points from baseline through 12 weeks
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 28 Feb 2025.
- 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.
Rui Chen, MD principal investigator
Peking Union Medical College Hospital
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 AK102 in people with Hypercholesterolaemia, 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 4 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 28 Feb 2025. 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. Some participants in this study may receive a placebo. 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?
Incidence of treatment emergent AE (time frame: From single dose of AK102 through 12 weeks). 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 28 Feb 2025.