Printed from Voxsanity (voxsanity.com.au) — NCT07301502 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 1 Alzheimer's Disease Trial, Not Yet Recruiting
NCT07301502
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
Part 1 – Healthy Volunteers:
- Men and women between 18 and 40 years old (inclusive) at the time of signing the consent form.
- People with a body weight of at least 50 kg (for men) or at least 45 kg (for women), and a body mass index (BMI — a measure based on height and weight) between 19.0 and 26.0.
- People who agree to use contraception as required by the study, and to avoid donating sperm or eggs from the time of consent through at least 90 days after the last dose of the study drug; women must not be pregnant or breastfeeding.
- People who are able to understand and voluntarily sign a consent form, and who are able to follow all study procedures and appointments.
Part 2 – People with Alzheimer's Disease:
- People between 50 and 85 years old (inclusive) at the time of signing the consent form.
- People with a BMI between 17.0 and 35.0.
- People who agree to use contraception as required by the study, and to avoid donating sperm or eggs from the time of consent through at least 90 days after the last dose; women must not be pregnant or breastfeeding.
- People who are able to understand and voluntarily sign a consent form, and who are able to follow all study procedures and appointments.
- People who have a designated "trial partner" (such as a carer or close contact) who is also willing to sign a consent form.
- People who meet established medical guidelines for mild cognitive impairment or mild dementia due to Alzheimer's disease (based on 2011 NIA-AA criteria — confirm with trial site).
- People whose brain scan (a type of PET/CT scan) shows the presence of amyloid protein deposits in the brain, confirmed at screening.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
Part 1 – Healthy Volunteers:
- People with a known allergy to any component of the study drug (AK152 injection) or to any monoclonal antibody (a type of laboratory-made medicine), or those considered at high risk of such an allergy.
- People with a history or current diagnosis of any significant illness or systemic disease that could affect the study results.
- People with clinically significant abnormal vital signs (such as blood pressure or heart rate) at screening or before the study begins.
- People with clinically significant abnormal blood or laboratory test results at screening or before the study begins, as judged by the investigator.
- People who have used any medication — including prescription drugs, over-the-counter medicines, herbal products, or dietary supplements — within 4 weeks before the study starts (or within 5 half-lives of that medication, whichever is longer), or who plan to use any such products during the study.
- People with a history of frequent alcohol use in the 24 weeks before the study, or who are unable to avoid alcohol during the inpatient (hospital stay) period.
- People with a history of drug misuse, or those who test positive on a urine drug screen at screening.
- People who smoke more than 5 cigarettes per day within 12 weeks before screening, or who are unable to avoid smoking during the inpatient period.
- People who consume excessive amounts of tea, coffee, or other caffeine-containing drinks (confirm acceptable limits with trial site).
Part 2 – People with Alzheimer's Disease:
- People with a history or current evidence of cancer affecting any part of the body within the past 5 years, regardless of whether it has been treated or is in remission — with some exceptions for certain fully treated, non-spreading skin or cervical cancers (confirm details with trial site).
- People with a severe or unstable medical condition at screening or before the study begins that could affect how study assessments are conducted.
- People with a significant neurological condition other than Alzheimer's disease that could affect thinking or the ability to complete study tasks.
- People who have had a mini-stroke (transient ischemic attack) or stroke within the 12 months before the study begins.
- People with clinically significant abnormal findings on a brain MRI scan at screening.
- People with a known allergy to any component of the study drug (AK152 injection) or to any monoclonal antibody, or those considered at high risk of such an allergy.
- People with a history of alcohol or drug misuse within the 2 years before screening or before the study begins.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Contact this trial
Phone: +86 (0760) 8987 3998
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
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Trial details
Status
Not Yet Recruiting
Phase
Phase 1
Sponsor
Akeso
Registry
ClinicalTrials.gov
Start date
1 December 2025
Est. completion
1 June 2027
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Adverse Events (AE)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 3 August 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.