Phase 1 Alzheimer's Disease Trial, Not Yet Recruiting
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
- People who have given voluntary written consent before any study-related activities begin.
- Men or women aged 18 to 55 years old at the time of giving consent.
- People who are able to become pregnant must agree to use two forms of contraception (a highly effective method plus a condom where appropriate) from the screening visit until 60 days after the last dose of the study medicine.
- Male participants with partners who are able to become pregnant must agree to use two forms of contraception (a condom plus a highly effective method used by their partner) from consent until 90 days after the last dose of the study medicine; men who have had a confirmed vasectomy at least 6 months before screening may also be eligible without this requirement.
- Male participants must also agree not to donate sperm and not to plan to father children for up to 90 days after the last dose of the study medicine.
- People who have smoked or used nicotine products only very rarely (no more than 5 cigarettes or the equivalent per month) for at least 32 months before screening, and whose nicotine or carbon monoxide test results at screening and the day before dosing fall within acceptable limits.
- Men weighing at least 50 kg, or women weighing at least 45 kg, with a body mass index (a measure of weight relative to height) between 18.0 and 30.0.
- People who are assessed as healthy by the study doctor based on a detailed medical history, physical examination, heart tracing (ECG), vital signs, and blood and urine tests, and who have suitable veins for taking blood samples.
- People whose blood pressure and heart rate, measured after resting for 5 minutes, fall within the ranges considered acceptable by the study doctor.
- People whose heart tracing (ECG) results, measured after lying down for 10 minutes, fall within the accepted ranges for heart rhythm measurements (confirm specific values with trial site).
- People who, in the study doctor's opinion, are willing and able to follow all study requirements (explained in English) and attend all required visits — including, for one part of the study, being willing and able to eat a high-fat meal within 30 minutes.
- People who are willing to delay donating blood to a blood service for at least 6 months after the end of the study.
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.
- People whose liver function blood test results at screening or the day before dosing are significantly above the normal range (confirm specific values with trial site).
- People with other significantly abnormal blood, urine, or heart tracing results during screening that the study doctor believes would affect their ability to safely participate.
- People who are pregnant, breastfeeding, planning to become pregnant or breastfeed, planning to donate eggs during the study, or who have a positive pregnancy test at screening or before the first dose.
- People with a current or past clinically relevant condition affecting the heart, lungs, digestive system, liver, gallbladder (including a history of gallstones without symptoms), kidneys, blood, nerves, muscles, joints, eyes, reproductive system, or with signs of current illness.
- People who have had surgery on their digestive system or have a digestive condition that could affect how the body processes medicine (for example, stomach removal, gallbladder removal, ongoing diarrhoea, or frequent nausea and vomiting).
- People who have had a cancer diagnosis within the past 5 years (with the exception of certain treated and cured skin or cervical cancers — confirm with trial site).
- People with a history of schizophrenia, bipolar disorder, psychosis, conditions requiring lithium treatment, attempted or planned suicide, or other severe long-term psychiatric conditions including depression, generalised anxiety, or obsessive-compulsive disorder, or who have been hospitalised for a psychiatric illness or for being a danger to themselves or others within the past 5 years.
- People with severe recurring headaches (such as cluster headaches or migraines) that require prescription medication.
- People who have donated more than 450 mL of blood or blood products within 8 weeks before the first dose.
- People with a documented history of heart disease, heart rhythm problems, significant abnormalities in the heart's electrical activity, or a family history of inherited heart conditions such as long QT syndrome, Brugada syndrome, or unexplained sudden cardiac death.
- People with a diagnosed or treated allergy to food or medicines, or any history of a severe allergic reaction such as swelling of the face, mouth, or throat, or breathing difficulties; or known allergy or sensitivity to the study medicine or similar medicines (note: untreated and symptom-free hay fever or dust or animal allergies at the time of dosing are not excluded).
- People who test positive at screening for hepatitis B, hepatitis C, or HIV.
- People with a history of seizures or convulsions, including those caused by a drug or vaccine (note: a single fever-related convulsion in childhood is not excluded).
- People with a history of alcohol or illicit drug misuse within the past 2 years, or who test positive for drugs or alcohol at screening or before the first dose (subject to the study doctor's assessment and limited retesting rules).
- People who currently smoke or use nicotine products at more than 5 cigarettes or the equivalent per month, or who have done so within the past 32 months, or whose nicotine or carbon monoxide test results at screening or on admission to the clinic exceed acceptable limits.
- People who have taken prescription medicines, over-the-counter medicines (including vitamins), or herbal remedies within 14 days before the day before first dosing, or who have had a vaccination within 28 days before that day (contraceptives and occasional use of non-prescription pain relief are permitted).
- People who, in the study doctor's opinion, are unlikely to follow the study requirements for any reason, or who have a medical condition that would make participation unsafe; for one part of the study, this includes people who are unwilling or unable to eat a high-fat meal within 30 minutes.
- People who have taken part in another clinical trial or received an experimental medicine within 90 days before the first dose (or longer, depending on the other medicine's properties), or who have previously received the study medicine in this trial.
- People who follow a vegan diet.
- People who are unwilling or unable to avoid grapefruit, Seville oranges, or their juices, and coffee or caffeine-containing drinks, for 48 hours before entering the clinic and until leaving.
- People who are employees of the study site or the study doctor's organisation with direct involvement in this or related studies, or who are immediate family members of such employees or the study doctor.
- People considered vulnerable, meaning those whose decision to take part may have been unfairly influenced by expected personal benefit or fear of negative consequences from someone in authority if they declined (for example, people in detention, minors, or those unable to give informed consent).
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.
If you need support right now
This page includes language about suicide and self-harm, because that is how the trial's eligibility criteria are written. If reading it has been hard, you do not have to keep going. The services below are free, confidential, and answered by people trained for exactly this.
If you or someone else is in immediate danger, call 000.
- Lifeline — 24/7 crisis support: 13 11 14
- Suicide Call Back Service — 24/7 counselling: 1300 659 467
- 13YARN — 24/7, for Aboriginal and Torres Strait Islander people: 13 92 76
- Beyond Blue — 24/7 mental health support: 1300 22 4636
- Kids Helpline — 24/7, free and private for anyone aged 5 to 25: 1800 55 1800
- headspace — mental health support for 12 to 25 year olds: headspace.org.au
- Emergency: 000
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention. If you are in immediate danger, call your local emergency number.
Voxsanity is not a crisis service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
Contact this trial
Phone: +82 10 4879 6001
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.
Where this trial is recruiting
1 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
To assess the safety and tolerability of single and multiple ascending oral doses of KS101 in healthy adult volunteers.; Evaluation of the safety and tolerability of a single oral dose of KS101 taken after a high-fat meal, assessed by changes observed during the physical examination.; Evaluation of the safety and tolerability of a single oral dose of KS101 taken after a high-fat meal, assessed by changes in haematology parameters.; Evaluation of the safety and tolerability of a single oral dose of KS101 taken after a high-fat meal, assessed by changes in serum biochemistry.; Evaluation of the...
Can't join this trial?
Data last synced from ClinicalTrials.gov: 14 August 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.