A Clinical Trial of AK152 in Healthy Volunteers and Patients With Alzheimer' s Disease
NCT ID: NCT07301502
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE1
108 participants
INTERVENTIONAL
2025-12-31
2027-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
AK152 regimen
AK152
Subjects receiving single or multiple doses of AK152 injection.
Placebo
Placebo
Subjects receiving single or multiple doses of placebo injection.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AK152
Subjects receiving single or multiple doses of AK152 injection.
Placebo
Subjects receiving single or multiple doses of placebo injection.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. 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).
3. 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.
4. 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.
1. 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.
2. Aged 50 to 85 years (inclusive) at the time of signing the ICF.
3. BMI within 17.0-35.0 kg/m² (inclusive).
4. 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.
5. The subject must have an identified trial partner who must sign a separate ICF.
6. Meets the 2011 NIA-AA core clinical criteria for MCI due to AD or mild AD dementia.
7. Evidence of brain amyloid deposition confirmed by Aβ-PET/CT at screening.
Exclusion Criteria
2. History or presence of any systemic disease that may interfere with study results.
3. Clinically significant abnormalities in vital signs at screening or prior to randomization.
4. Clinically significant laboratory abnormalities at screening or prior to randomization per investigator judgment.
5. 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.
6. History of frequent alcohol consumption within 24 weeks or inability to abstain during inpatient stay.
7. Drug abuse or positive urine drug screen at screening.
8. Smokers consuming \>5 cigarettes/day within 12 weeks prior to screening or unable to abstain during the inpatient period.
9. Excessive intake of tea, coffee, or other caffeine-containing beverages.
1. 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).
2. Severe or unstable disease at screening or prior to randomization that may affect study assessments.
3. Major neurological disorder (other than AD) that may affect cognition or ability to complete study procedures.
4. Transient ischemic attack (TIA) or stroke within 12 months prior to randomization.
5. Clinically significant abnormalities on brain MRI at screening.
6. Known allergy to components of AK152 injection or any monoclonal antibody, or high risk of allergy.
7. History of alcohol or drug abuse within 2 years prior to screening or prior to randomization.
18 Years
85 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Akeso
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Frist Affiliated Hospital of USTC
Hefei, Anhui, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AK152-101
Identifier Type: -
Identifier Source: org_study_id