Alzheimer' s DiseasePhase 1NCT07301502
A Clinical Trial of AK152 in Healthy Volunteers and Patients With Alzheimer' s Disease
A Phase 1 study testing AK152 in people with Alzheimer' s Disease, run by Akeso at 1 site in China.
Trial summary
This is a randomized, double-blind phase I clinical trial to evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of AK152 in Healthy Volunteers and Patients with Alzheimer' s Disease. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer' s Disease
- What is being tested?
- AK152
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- Dec 2025to Jun 2027
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female subjects aged 18 to 40 years (inclusive) at the time of signing the informed consent form (ICF).
- Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females; body mass index (BMI) = weight (kg) / height² (m²) within the range of 19.0-26.0 kg/m² (inclusive).
- Subjects agree to take protocol-specified contraception measures and refrain from donating sperm or oocytes from signing the ICF through the treatment period and for at least 90 days after the last administration of study drug; women of childbearing potential must be non-pregnant and non-lactating.
- Subjects are able to understand and voluntarily sign a written ICF before any study-specific procedures are performed, and are able to comply with the study procedures and follow-up requirements.
Who cannot join
- Known allergy to components of AK152 injection or any monoclonal antibody, or high risk of allergy.
- History or presence of any systemic disease that may interfere with study results.
- Clinically significant abnormalities in vital signs at screening or prior to randomization.
- Clinically significant laboratory abnormalities at screening or prior to randomization per investigator judgment.
- Use of any medication (including prescription, OTC, herbal medicines, dietary supplements) within 4 weeks before randomization or within 5 half-lives of the medication (whichever is longer), or planned use during the study.
- History of frequent alcohol consumption within 24 weeks or inability to abstain during inpatient stay.
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- Drug abuse or positive urine drug screen at screening.
- Smokers consuming >5 cigarettes/day within 12 weeks prior to screening or unable to abstain during the inpatient period.
- Excessive intake of tea, coffee, or other caffeine-containing beverages.
- Key Inclusion Criteria - Part 2 (Alzheimer' s Disease Patients):
- Able to understand and voluntarily sign a written ICF before any study-specific procedures are performed, and able to comply with study procedures and follow-up requirements.
- Aged 50 to 85 years (inclusive) at the time of signing the ICF.
- BMI within 17.0-35.0 kg/m² (inclusive).
- Subjects agree to take protocol-specified contraception measures and refrain from donating sperm or oocytes from signing the ICF through the treatment period and for at least 90 days after the last dose; women must be non-pregnant and non-lactating.
- The subject must have an identified trial partner who must sign a separate ICF.
- Meets the 2011 NIA-AA core clinical criteria for MCI due to AD or mild AD dementia.
- Evidence of brain amyloid deposition confirmed by Aβ-PET/CT at screening.
- Key Exclusion Criteria - Part 2 (Alzheimer' s Disease Patients):
- History or evidence of malignancy involving any organ system within 5 years prior to screening, regardless of treatment or remission status (except completely cured carcinoma in situ of the cervix, non-metastatic squamous cell carcinoma of the skin, or basal cell carcinoma).
- Severe or unstable disease at screening or prior to randomization that may affect study assessments.
- Major neurological disorder (other than AD) that may affect cognition or ability to complete study procedures.
- Transient ischemic attack (TIA) or stroke within 12 months prior to randomization.
- Clinically significant abnormalities on brain MRI at screening.
- Known allergy to components of AK152 injection or any monoclonal antibody, or high risk of allergy.
- History of alcohol or drug abuse within 2 years prior to screening or prior to randomization.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of AK152 in Healthy Volunteers and Patients With Alzheimer' s Disease
This is a randomized, double-blind phase I clinical trial to evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of AK152 in Healthy Volunteers and Patients with Alzheimer' s Disease.
Read the detailed description
This is a randomized, double-blind phase I clinical trial to evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of AK152 in Healthy Volunteers and Patients with Alzheimer' s Disease. Subjects will be randomized to receive AK152 regimen or placebo treatment.
- Conditions
- Alzheimer' s Disease
- Being tested
- AK152, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK152Drug
Subjects receiving single or multiple doses of AK152 injection.
PlaceboDrug
Subjects receiving single or multiple doses of placebo injection.
| Study group | Role | What they receive |
|---|---|---|
| AK152 regimen | Active comparator | Not described Receives: Drug: AK152 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AE)
The incidence of AEs.
Measured: Up to approximately 8 weeks after the last dose
Secondary outcomes (5)
Peak concentration (Cmax)
Measure and assess the Cmax of AK152.
Measured: Up to approximately 8 weeks after the last dose
Time to peak (Tmax)
Measure and assess the Tmax of AK152.
Measured: Up to approximately 8 weeks after the last dose
Area under the curve (AUC)
Measure and assess the AUC of AK152.
Measured: Up to approximately 8 weeks after the last dose
Half-life (t1/2)
Measure and assess the t1/2 of AK152.
Measured: Up to approximately 8 weeks after the last dose
Immunogenicity characteristics of AK152
Number and percentage of subjects with detectable anti-drug antibodies (ADA) and neutralizing antibodies (Nab) after treatment.
Measured: Up to approximately 8 weeks after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer' s DiseaseStudies 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
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07301502
- Sponsor's protocol ID
- AK152-101
- Status last verified
- Dec 2025
- First submitted
- 1 Dec 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- 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 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of AK152 in Healthy Volunteers and Patients With Alzheimer' s Disease
- ClinicalTrials.gov ID
- NCT07301502
- Acronym / sponsor ID
- AK152-101
- Conditions
- Alzheimer' s Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- Dec 2025 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 24 Dec 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 randomized, double-blind phase I clinical trial to evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of AK152 in Healthy Volunteers and Patients with Alzheimer' s Disease.
Detailed description
This is a randomized, double-blind phase I clinical trial to evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of AK152 in Healthy Volunteers and Patients with Alzheimer' s Disease. Subjects will be randomized to receive AK152 regimen or placebo treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AK152 regimen | Active comparator | Drug: AK152 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy male or female subjects aged 18 to 40 years (inclusive) at the time of signing the informed consent form (ICF).
- Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females; body mass index (BMI) = weight (kg) / height² (m²) within the range of 19.0-26.0 kg/m² (inclusive).
- Subjects agree to take protocol-specified contraception measures and refrain from donating sperm or oocytes from signing the ICF through the treatment period and for at least 90 days after the last administration of study drug; women of childbearing potential must be non-pregnant and non-lactating.
- Subjects are able to understand and voluntarily sign a written ICF before any study-specific procedures are performed, and are able to comply with the study procedures and follow-up requirements.
Key exclusion criteria (25 listed)
- Known allergy to components of AK152 injection or any monoclonal antibody, or high risk of allergy.
- History or presence of any systemic disease that may interfere with study results.
- Clinically significant abnormalities in vital signs at screening or prior to randomization.
- Clinically significant laboratory abnormalities at screening or prior to randomization per investigator judgment.
- Use of any medication (including prescription, OTC, herbal medicines, dietary supplements) within 4 weeks before randomization or within 5 half-lives of the medication (whichever is longer), or planned use during the study.
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 |
|---|---|---|
| AK152Subjects receiving single or multiple doses of AK152 injection. | Drug | AK152 regimen |
| PlaceboSubjects receiving single or multiple doses of placebo injection. | Drug | Placebo |
Primary outcome
Adverse Events (AE)
Time frame: Up to approximately 8 weeks after the last dose
The incidence of AEs.
5 secondary outcomes
Peak concentration (Cmax)
Time frame: Up to approximately 8 weeks after the last dose
Time to peak (Tmax)
Time frame: Up to approximately 8 weeks after the last dose
Area under the curve (AUC)
Time frame: Up to approximately 8 weeks after the last dose
Half-life (t1/2)
Time frame: Up to approximately 8 weeks after the last dose
Immunogenicity characteristics of AK152
Time frame: Up to approximately 8 weeks after the last dose
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 24 Dec 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.
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 AK152 in people with Alzheimer' s Disease, 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 25 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 24 Dec 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?
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 3998, global.trials@akesobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (AE) (time frame: Up to approximately 8 weeks after the last dose). 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 24 Dec 2025.