Healthy ParticipantsPhase 1NCT07143331
A Phase 1 Study to Assess the Safety and Effects of Single and Multiple Doses of KS101 in Healthy Volunteers
A Phase 1 study testing Part 1 KS101, Part 2 with Food and Part 2 without food in people with Healthy Participants and Alzheimer Disease, run by Klotho Sciences Australia Pty Ltd. at 1 site in Australia.
Trial summary
This study is the first clinical trial involving study drug KS101. The goal of this clinical trial is to investigate whether KS101 is safe, whether it causes side effects, and how KS101 is broken down in the body, in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants, Alzheimer Disease, Chronic Kidney Disease
- What is being tested?
- Part 1 KS101, Part 2 with Food and Part 2 without food
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteAustralia
- Study dates
- 30 Aug 2025to 6 Aug 2026
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provided voluntary, written informed consent before any study-specific activities are performed.
- Male or female, aged 18 to 55 years inclusive at time of informed consent.
- Participants of childbearing potential must agree to the use of a double method of contraception of a highly effective method of birth control (refer to Appendix 11.1) combined with a barrier contraceptive (condom) when appropriate from screening visit to until 60 days after the last dose of IMP (covering a full menstrual cycle of 30 days starting after 5 half-lives of last dose of IMP). Childbearing potential is defined as fertile and following menarche until becoming post-menopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Post-menopausal is defined as no menses for 12 months without an alternative medical cause and a Screening follicle stimulating hormone (FSH) level >30 U/L (or at the local laboratory levels for post-menopause).
- Male participants with sexual partners of childbearing potential must agree to use a double method of contraception including condom with a highly effective method of birth control by the partner of childbearing potential (refer to Appendix 11.1), from the time of informed consent through to 90 days after the last dose of the IMP. Male participants who have undergone sterilisation (i.e., vasectomy ≥6 months before Screening) and have had testing to confirm the success of the sterilisation, may also be included and will not be required to use above described methods of contraception. Male participants must also agree not to donate sperm or plan to father children for up to 90 days after last dose of IMP.
- Non-smoker (or other nicotine use) (defined as ≤5 cigarettes or nicotine equivalent per month) for at least 32 months before Screening according to history, and urine cotinine <500 ng/mL or carbon monoxide (CO) breath test <10 ppm at Screening and Day -1.
- Total body weight ≥50 kg (male) or ≥45 kg (female) and body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive.
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- Certified as healthy by comprehensive clinical assessment by the Investigator (detailed medical history, complete physical examination, vital signs, 12-lead electrocardiogram, and clinical laboratory evaluation) and with suitable veins for cannulation.
- Vital signs after 5 minutes resting in supine position (one repeat per timepoint permitted):
- Systolic blood pressure (SBP): 90 - 140 mmHg inclusive
- Diastolic blood pressure (DBP): 50 - 90 mmHg inclusive. DBP 40 - 49 mmHg inclusive is acceptable for eligibility if considered not clinically significant by the Investigator.
- Heart rate (HR): 50 - 90 bpm inclusive. HR 40 - 49 bpm inclusive are acceptable for eligibility if considered not clinically significant by the Investigator.
- Standard 12-lead electrocardiogram (ECG) parameters, after 10 minutes in supine position within the following ranges:
- QRS 50 - 120 msec
- QT ≤500 msec
- QTcF and QTcB ≤450 msec (male) ≤470 msec (female) Also: normal ECG tracing, or ECG tracing abnormality considered by the Investigator to be not clinically significant (not including parameters above).
- In the opinion of the Investigator, is willing and able to comply with and understand study requirements provided in English and be available for the required study visits. For Part 2 FE, this includes being willing and able to consume a high-fat meal (≥50% fat) within 30 minutes.
- Is willing to defer blood donations to a blood service for minimum 6 months after the End of study visit.
Who cannot join
- Liver function tests at Screening and Day -1: aspartate aminotransferase [AST], alanine aminotransferase [ALT],) >2 times upper limit of normal (ULN), serum alkaline phosphatase (ALP) or total bilirubin ≥2 times ULN. One re-test per parameter per timepoint is permitted, results must be available before randomization.
- Clinically significant abnormalities in laboratory tests (biochemistry, haematology, coagulation, urinalysis), physical examination, or 12-lead ECG during the Screening period or pre-first dose, that in the opinion of the Investigator, would affect the individual's ability to fully participate in the study and/or not be in the individual's best interest to participate in the study. One re-test per abnormality per scheduled timepoint is permitted
- Pregnant or breastfeeding, or planning to become pregnant or breastfeed, or planning to donate ova during study participation; or positive pregnancy test at screening/pre-first dose. Males planning to father children or unwilling to abstain from sperm donation within 90 days of the last dose of study product.
- History or presence of clinically relevant (as assessed by the Investigator) cardiovascular, broncho-pulmonary, gastrointestinal, hepatic/ gallbladder*/ bile duct, renal, metabolic, hematological, neurological, musculoskeletal/rheumatological, systemic, ocular, gynaecological, or infectious disease or signs of acute illness. *including medical history of asymptomatic gallbladder stones.
- Any gastrointestinal surgery or condition or disease that could affect drug absorption, distribution, metabolism or excretion (e.g., gastrectomy, cholecystectomy, diarrhea, recurrent nausea/vomiting).
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer considered treated and cured), treated or untreated, within 5 years before screening, regardless of if there is no evidence of local recurrence or metastases.
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- History of schizophrenia, bipolar disorder psychoses, disorders requiring lithium, attempted or planned suicide, or any other severe (disabling) chronic psychiatric diagnosis including depression, generalised anxiety and obsessive-compulsive disorders. Hospitalization within 5 years before screening due to psychiatric illness or due to danger to self or others.
- Severe recurring headache (cluster or migrainous headaches) requiring prescription medication.
- Donation of >450 mL blood or blood products within 8 weeks before first dose.
- Documented evidence of current or past cardiovascular disease including cardiac arrhythmias, clinical significant abnormal cardiac automaticity, or family history of congenital long QT syndrome, Brugada syndrome, or unexplained sudden cardiac death.
- History or presence of diagnosed (by an allergist/immunologist) or treated (by a physician) food or known drug allergy, or any history of anaphylaxis or other severe allergic reactions including face, mouth, or throat swelling or any difficulty breathing. Allergy, hypersensitivity or intolerance to KS101, including excipients, or to medicinal products with similar chemical structures. Note: Seasonal allergies ('hay fever') or allergy to animal or house dust mite that are untreated and asymptomatic at time of dosing are not exclusionary.
- Positive serology test at Screening for hepatitis B surface antigen (HBsAg), hepatitis C (HCV) antibody, or human immune deficiency virus (HIV) antibody.
- History of convulsion (including drug or vaccine-induced episodes). Note: Medical history of a single febrile convulsion during childhood is not exclusionary.
- History of alcohol or illicit drug misuse within 2 years before Screening, as determined by the Investigator and/or positive urine drug test at Screening or pre-first dose (unless there is an explanation deemed acceptable by the Investigator [e.g., false positive] and/or the participant tests negative upon re-test [one re-test permitted per scheduled timepoint]) and/or positive alcohol breath test at Screening or pre-first dose (no re-test permitted).
- Current tobacco smoker or other nicotine use >5 cigarettes or nicotine equivalent per month within 32 months of Screening, or at Screening or upon admission to the clinical unit had urine cotinine of ≥500 ng/mL or CO breath test >10 ppm.
- Use of prescription medicines, over-the-counter (OTC) medications (including vitamins), or herbal remedies within 14 days and/or vaccination within 28 days before Day -1. Contraceptives and occasional/non-chronic use (as judged by the Investigator) of non-prescription analgesia (e.g., ibuprofen, paracetamol) are permitted.
- In the judgement of the Investigator, individual is likely to be noncompliant or unable to comply with study requirements during the study for any reason (e.g., inability to return for follow-up visits, uncooperative attitude), and/or has a medical condition jeopardizing involvement in the study. For Part 2 FE, this includes individuals unwilling or unable to consume a high-fat meal within 30 minutes.
- Administered an investigational drug within 90 days before first dose, or within 5 times the half-life of the other investigational product (if known), whichever is longer, or previously received study treatment in this study
- Is vegan.
- Not willing or able to avoid consumption of grapefruit or Seville oranges or their juices and/or coffee/caffeine-containing beverages within 48 hours before admission to the clinical unit and until discharge from the unit.
- Identified as a site employee of the Investigator or study centre, with direct involvement in the proposed study or other studies under the direction of that Investigator or study centre, as well as family members (i.e., immediate, husband, wife or de facto and their children, adopted or natural) of the site employees or the Investigator.
- Considered vulnerable, defined as individuals whose willingness to participate in a clinical study may have been unduly influenced by expectation of benefits associated with participation (justified or not), or of a retaliatory response from senior hierarchy members in case of refusal to participate (e.g., persons in detention, minors, and those incapable of giving informed consent).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hyunjong Sung contact
About this study
Official title: A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetic Profile of Single and Multiple Ascending Doses of KS101 in Healthy Volunteers, Including a Pilot Food Effect Evaluation
This study is the first clinical trial involving study drug KS101. The goal of this clinical trial is to investigate whether KS101 is safe, whether it causes side effects, and how KS101 is broken down in the body, in healthy participants.
This information will be used to learn more about KS101 and to determine the most effective dose for age related diseases such as chronic kidney disease and Alzheimer's Disease, with the fewest unwanted side effects.
Read more
There are 3 parts to this study. In Part 1, participants will take KS101 or a placebo once and will stay in the study centre for a 4-night inpatient stay. Participants will return for outpatient visits on Days 8 and 29.
In Part 2, participants will take KS101 twice, once after a meal and once without a meal and will stay in the study centre for a 7-night inpatient stay. Participants will return for outpatient visits on Days 11 and 32.
In Part 3, participants will take KS101 or a placebo once daily for 5 days and will stay in the study centre for an 8-night inpatient stay. Participants will return for outpatient visits on Days 12 and 33.
Read the detailed description
This is a Phase 1, 3-part study to evaluate the safety, tolerability, and pharmacokinetic (PK) profile following the oral administration of single and multiple ascending doses of KS101 in healthy participants, including a food effect evaluation.
Part 1 will include six single ascending dose cohorts of 8 participants per cohort (randomised 6 active, 2 placebo). For each cohort, a sentinel group of 2 participants (1 active, 1 placebo) will be dosed first. These participants will be on study for up to 59 days in total.
Part 2 will be a crossover evaluation, with and without food (randomised sequence). 12 participants will receive 2 doses of KS101 72 hours apart, one dose under fasting conditions and one dose under fed conditions. These participants will be on study for up to 61days in total.
Part 3 will include three multiple ascending dose cohorts of 8 participants per cohort (randomised 6 active, 2 placebo). These participants will receive one dose for 5 consecutive days and will be on study for up to 63 days in total.
- Being tested
- Part 1 KS101, Part 1 Placebo, Part 2 with Food, Part 2 without food, Part 3 KS101
- Keywords
- alzheimer disease, chronic kidney disease
- Medical subject headings
- Alzheimer Disease, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Part 1 KS101Drug
Six doses of oral KS101 will be administered to participants.
Part 1 PlaceboDrug
Six doses of oral matching placebo will be administered to participants.
Part 2 with FoodDrug
KS101 administered with food
Part 2 without foodDrug
KS101 administered without food
Part 3 KS101Drug
3 multiple doses of KS101
| Study group | Role | What they receive |
|---|---|---|
| Part 1 KS101 | Experimental | Participants will be enrolled in 1 of 6 single ascending dose cohorts. Six participants in each cohort will receive KS101. Receives: Drug: Part 1 KS101 |
| Part 1 Placebo | Placebo comparator | 6 doses of placebo will be administered to participants Receives: Drug: Part 1 Placebo |
| Part 2 KS101 with Food | Experimental | KS101 with food Receives: Drug: Part 2 with Food |
| Part 2 KS101 without Food | Experimental | KS101 without food Receives: Drug: Part 2 without food |
| Part 3 KS101 | Experimental | Multiple ascending doses of KS101 Receives: Drug: Part 3 KS101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of single and multiple ascending oral doses of KS101 in healthy adult volunteers.
Number of participants reporting treatment emergent adverse events (TEAEs) including treatment-related TEAEs, serious adverse events (SAEs) and TEAEs of severity grade 3 or above.
Measured: Through to end of study, up to 63 days.
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.
Presence of clinically significant changes in participants physical examinations post-first dose.
Measured: Through to end of study, up to 63 days.
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.
Presence of clinically significant changes in participants haematology parameters post-first dose.
Measured: Through to end of study, up to 63 days.
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.
Presence of clinically significant changes in participants serum biochemistry parameters post-first dose.
Measured: Through to end of study, up to 63 days.
Evaluation of the safety and tolerability of a single oral dose of KS101 taken after a high-fat meal, assessed by changes in coagulation parameters.
Presence of clinically significant changes in participants coagulation parameters post-first dose.
Measured: Through to end of study, up to 63 days.
Evaluation of the safety and tolerability of a single oral dose of KS101 taken after a high-fat meal, assessed by changes in urinalysis parameters.
Presence of clinically significant changes in participants urinalysis parameters post-first dose.
Measured: Through to end of study, up to 63 days.
Evaluation of the safety and tolerability of a single oral dose of KS101 taken after a high-fat meal, assessed by changes in vital signs.
Presence of clinically significant changes in participants vital signs post-first dose.
Measured: Through to end of study, up to 63 days.
Evaluation of the safety and tolerability of a single oral dose of KS101 taken after a high-fat meal, assessed by changes in ECG parameters.
Presence of clinically significant changes in participants ECG parameters post-first dose.
Measured: Through to end of study, up to 63 days.
Secondary outcomes (22)
Pharmacokinetics parameter - High-fat, high-calorie meal effects maximum observed concentration (Cmax).
The effect of a standardised high-fat, high-calorie meal on the maximum observed concentration of the study drug in serum will be analyzed for all participants.
Measured: Through to 7 days post last dose.
Pharmacokinetics parameter - High-fat, high-calorie meal effects on Area under the curve (AUC).
The effect of a standardised high-fat, high-calorie meal on the area under the curve of the study drug in serum will be analyzed for all participants.
Measured: Through to 7 days post last dose.
Pharmacokinetics parameter - High-fat, high-calorie meal effects on time for maximum observed Concentration (Tmax).
The effect of a standardised high-fat, high-calorie meal on the Serum PK Tmax will be analyzed for all participants.
Measured: Through to 7 days post last dose.
Pharmacokinetics parameter - single dose of KS101 effects maximum observed concentration (Cmax).
The effect of a single dose of KS101 on the maximum observed concentration of the study drug in serum will be analyzed for all participants.
Measured: Through to 7 days post last dose.
Pharmacokinetics parameter - multiple doses of KS101 effects maximum observed concentration (Cmax).
The effect of multiple doses of KS101 on the maximum observed concentration of the study drug in serum will be analyzed for all participants.
Measured: Through to 7 days post last dose.
Pharmacokinetics parameter - single dose of KS101 effects on Area under the curve (AUC).
The effect of a single dose of KS101 on the area under the curve of the study drug in serum will be analyzed for all participants.
Measured: Through to 7 days post last dose.
Pharmacokinetics parameter - multiple doses of KS101 effects on Area under the curve (AUC).
The effect of multiple doses of KS101 on the area under the curve of the study drug in serum will be analyzed for all participants.
Measured: Through to 7 days post last dose.
Pharmacokinetics parameter - single dose of KS101 effects on time for maximum observed Concentration (Tmax).
The effect of a single dose of KS101 on the Serum PK Tmax will be analyzed for all participants.
Measured: Through to 7 days post last dose.
Pharmacokinetics parameter - multiple doses of KS101 effects on time for maximum observed Concentration (Tmax).
The effect of multiple doses of KS101 on the Serum PK Tmax will be analyzed for all participants.
Measured: Through to 7 days post last dose.
Pharmacokinetics parameter - single dose of KS101 effects on KS101 half-life (t1/2).
The effect of a single dose of KS101 on the KS101 half-life (t1/2) will be analyzed for all participants.
Measured: Through to 7 days post last dose.
Pharmacokinetics parameter - multiple doses of KS101 effects on KS101 half-life (t1/2)
The effect of multiple doses of KS101 on KS101 half-life (t1/2) will be analyzed for all participants.
Measured: Through to 7 days post last dose.
Pharmacokinetics parameter - multiple doses of KS101 effects on its bioavailability (CL/F).
The effect of multiple doses of KS101 on its bioavailability (CL/F) will be analyzed for all participants.
Measured: Through to 7 days post last dose.
Pharmacokinetics parameter - single dose of KS101 effects on its bioavailability (CL/F).
The effect of a single dose of KS101 on its bioavailability (CL/F) will be analyzed for all participants.
Measured: Through to 7 days post last dose.
Pharmacokinetics parameter - multiple doses of KS101 effects on the apparent volume of distribution (Vz/F).
The effect of multiple doses of KS101 on the apparent volume of distribution (Vz/F) will be analyzed for all participants.
Measured: Through to 7 days post last dose.
Pharmacokinetics parameter - single dose of KS101 effects on the apparent volume of distribution (Vz/F).
The effect of a single dose of KS101 on the apparent volume of distribution (Vz/F) will be analyzed for all participants.
Measured: Through to 7 days post last dose.
Pharmacokinetics parameter - multiple doses of KS101 effects on the apparent elimination rate constant (KEL).
The effect of multiple doses of KS101 on the elimination rate constant (KEL) will be analyzed for all participants.
Measured: Through to 7 days post last dose.
Pharmacokinetics parameter - single dose of KS101 effects on the elimination rate constant (KEL).
The effect of a single dose of KS101 on the elimination rate constant (KEL) will be analyzed for all participants.
Measured: Through to 7 days post last dose.
Pharmacokinetics parameter - multiple doses of KS101 effects on the accumulation index (RAC).
The effect of multiple doses of KS101 on the accumulation index (RAC) will be analyzed for all participants.
Measured: Through to 7 days post last dose.
Investigate the dose proportionality of multiple doses of KS101 on untransformed Cmax.
For each Part 3 dose: untransformed Cmax will be analysed for all participants.
Measured: Through to Day 5.
Investigate the dose proportionality of multiple doses of KS101 on area under the curve (AUC).
For each Part 3 dose: area under the curve (AUC) will be analysed for all participants.
Measured: Through to Day 5.
investigate the dose proportionality of single doses of KS101 on untransformed CMAX.
For each Part 1 dose: untransformed Cmax will be analysed for all participants.
Measured: Through to end of study, up to 63 days.
investigate the dose proportionality of single doses of KS101 on the area under the curve (AUC).
For each Part 1 dose: the area under the curve (AUC) will be analysed for all participants.
Measured: Through to end of study, up to 63 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start30 Aug 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion6 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- 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
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klotho Sciences Australia Pty Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07143331
- Sponsor's protocol ID
- KS101-CLIN-001
- Status last verified
- Aug 2025
- First submitted
- 3 Aug 2025
- Last updated
- 27 Aug 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 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetic Profile of Single and Multiple Ascending Doses of KS101 in Healthy Volunteers, Including a Pilot Food Effect Evaluation
- ClinicalTrials.gov ID
- NCT07143331
- Acronym / sponsor ID
- KS101-CLIN-001
- Keywords
- alzheimer disease, chronic kidney disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Klotho Sciences Australia Pty Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Aug 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 6 Aug 2026 (estimated)
- First posted
- 27 Aug 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 study is the first clinical trial involving study drug KS101. The goal of this clinical trial is to investigate whether KS101 is safe, whether it causes side effects, and how KS101 is broken down in the body, in healthy participants.
This information will be used to learn more about KS101 and to determine the most effective dose for age related diseases such as chronic kidney disease and Alzheimer's Disease, with the fewest unwanted side effects.
There are 3 parts to this study. In Part 1, participants will take KS101 or a placebo once and will stay in the study centre for a 4-night inpatient stay. Participants will return for outpatient visits on Days 8 and 29.
In Part 2, participants will take KS101 twice, once after a meal and once without a meal and will stay in the study centre for a 7-night inpatient stay. Participants will return for outpatient visits on Days 11 and 32.
In Part 3, participants will take KS101 or a placebo once daily for 5 days and will stay in the study centre for an 8-night inpatient stay. Participants will return for outpatient visits on Days 12 and 33.
Detailed description
This is a Phase 1, 3-part study to evaluate the safety, tolerability, and pharmacokinetic (PK) profile following the oral administration of single and multiple ascending doses of KS101 in healthy participants, including a food effect evaluation.
Part 1 will include six single ascending dose cohorts of 8 participants per cohort (randomised 6 active, 2 placebo). For each cohort, a sentinel group of 2 participants (1 active, 1 placebo) will be dosed first. These participants will be on study for up to 59 days in total.
Part 2 will be a crossover evaluation, with and without food (randomised sequence). 12 participants will receive 2 doses of KS101 72 hours apart, one dose under fasting conditions and one dose under fed conditions. These participants will be on study for up to 61days in total.
Part 3 will include three multiple ascending dose cohorts of 8 participants per cohort (randomised 6 active, 2 placebo). These participants will receive one dose for 5 consecutive days and will be on study for up to 63 days in total.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1 KS101 | Experimental | Drug: Part 1 KS101Participants will be enrolled in 1 of 6 single ascending dose cohorts. Six participants in each cohort will receive KS101. |
| Part 1 Placebo | Placebo comparator | Drug: Part 1 Placebo6 doses of placebo will be administered to participants |
| Part 2 KS101 with Food | Experimental | Drug: Part 2 with FoodKS101 with food |
| Part 2 KS101 without Food | Experimental | Drug: Part 2 without foodKS101 without food |
| Part 3 KS101 | Experimental | Drug: Part 3 KS101Multiple ascending doses of KS101 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Provided voluntary, written informed consent before any study-specific activities are performed.
- Male or female, aged 18 to 55 years inclusive at time of informed consent.
- Participants of childbearing potential must agree to the use of a double method of contraception of a highly effective method of birth control (refer to Appendix 11.1) combined with a barrier contraceptive (condom) when appropriate from screening visit to until 60 days after the last dose of IMP (covering a full menstrual cycle of 30 days starting after 5 half-lives of last dose of IMP). Childbearing potential is defined as fertile and following menarche until becoming post-menopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Post-menopausal is defined as no menses for 12 months without an alternative medical cause and a Screening follicle stimulating hormone (FSH) level >30 U/L (or at the local laboratory levels for post-menopause).
- Male participants with sexual partners of childbearing potential must agree to use a double method of contraception including condom with a highly effective method of birth control by the partner of childbearing potential (refer to Appendix 11.1), from the time of informed consent through to 90 days after the last dose of the IMP. Male participants who have undergone sterilisation (i.e., vasectomy ≥6 months before Screening) and have had testing to confirm the success of the sterilisation, may also be included and will not be required to use above described methods of contraception. Male participants must also agree not to donate sperm or plan to father children for up to 90 days after last dose of IMP.
- Non-smoker (or other nicotine use) (defined as ≤5 cigarettes or nicotine equivalent per month) for at least 32 months before Screening according to history, and urine cotinine <500 ng/mL or carbon monoxide (CO) breath test <10 ppm at Screening and Day -1.
Key exclusion criteria (22 listed)
- Liver function tests at Screening and Day -1: aspartate aminotransferase [AST], alanine aminotransferase [ALT],) >2 times upper limit of normal (ULN), serum alkaline phosphatase (ALP) or total bilirubin ≥2 times ULN. One re-test per parameter per timepoint is permitted, results must be available before randomization.
- Clinically significant abnormalities in laboratory tests (biochemistry, haematology, coagulation, urinalysis), physical examination, or 12-lead ECG during the Screening period or pre-first dose, that in the opinion of the Investigator, would affect the individual's ability to fully participate in the study and/or not be in the individual's best interest to participate in the study. One re-test per abnormality per scheduled timepoint is permitted
- Pregnant or breastfeeding, or planning to become pregnant or breastfeed, or planning to donate ova during study participation; or positive pregnancy test at screening/pre-first dose. Males planning to father children or unwilling to abstain from sperm donation within 90 days of the last dose of study product.
- History or presence of clinically relevant (as assessed by the Investigator) cardiovascular, broncho-pulmonary, gastrointestinal, hepatic/ gallbladder*/ bile duct, renal, metabolic, hematological, neurological, musculoskeletal/rheumatological, systemic, ocular, gynaecological, or infectious disease or signs of acute illness. *including medical history of asymptomatic gallbladder stones.
- Any gastrointestinal surgery or condition or disease that could affect drug absorption, distribution, metabolism or excretion (e.g., gastrectomy, cholecystectomy, diarrhea, recurrent nausea/vomiting).
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 |
|---|---|---|
| Part 1 KS101Six doses of oral KS101 will be administered to participants. | Drug | Part 1 KS101 |
| Part 1 PlaceboSix doses of oral matching placebo will be administered to participants. | Drug | Part 1 Placebo |
| Part 2 with FoodKS101 administered with food | Drug | Part 2 KS101 with Food |
| Part 2 without foodKS101 administered without food | Drug | Part 2 KS101 without Food |
| Part 3 KS1013 multiple doses of KS101 | Drug | Part 3 KS101 |
Primary outcome
To assess the safety and tolerability of single and multiple ascending oral doses of KS101 in healthy adult volunteers.
Time frame: Through to end of study, up to 63 days.
Number of participants reporting treatment emergent adverse events (TEAEs) including treatment-related TEAEs, serious adverse events (SAEs) and TEAEs of severity grade 3 or above.
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.
Time frame: Through to end of study, up to 63 days.
Presence of clinically significant changes in participants physical examinations post-first dose.
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.
Time frame: Through to end of study, up to 63 days.
Presence of clinically significant changes in participants haematology parameters post-first dose.
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.
Time frame: Through to end of study, up to 63 days.
Presence of clinically significant changes in participants serum biochemistry parameters post-first dose.
Evaluation of the safety and tolerability of a single oral dose of KS101 taken after a high-fat meal, assessed by changes in coagulation parameters.
Time frame: Through to end of study, up to 63 days.
Presence of clinically significant changes in participants coagulation parameters post-first dose.
Evaluation of the safety and tolerability of a single oral dose of KS101 taken after a high-fat meal, assessed by changes in urinalysis parameters.
Time frame: Through to end of study, up to 63 days.
Presence of clinically significant changes in participants urinalysis parameters post-first dose.
Evaluation of the safety and tolerability of a single oral dose of KS101 taken after a high-fat meal, assessed by changes in vital signs.
Time frame: Through to end of study, up to 63 days.
Presence of clinically significant changes in participants vital signs post-first dose.
Evaluation of the safety and tolerability of a single oral dose of KS101 taken after a high-fat meal, assessed by changes in ECG parameters.
Time frame: Through to end of study, up to 63 days.
Presence of clinically significant changes in participants ECG parameters post-first dose.
22 secondary outcomes
Pharmacokinetics parameter - High-fat, high-calorie meal effects maximum observed concentration (Cmax).
Time frame: Through to 7 days post last dose.
Pharmacokinetics parameter - High-fat, high-calorie meal effects on Area under the curve (AUC).
Time frame: Through to 7 days post last dose.
Pharmacokinetics parameter - High-fat, high-calorie meal effects on time for maximum observed Concentration (Tmax).
Time frame: Through to 7 days post last dose.
Pharmacokinetics parameter - single dose of KS101 effects maximum observed concentration (Cmax).
Time frame: Through to 7 days post last dose.
Pharmacokinetics parameter - multiple doses of KS101 effects maximum observed concentration (Cmax).
Time frame: Through to 7 days post last dose.
Pharmacokinetics parameter - single dose of KS101 effects on Area under the curve (AUC).
Time frame: Through to 7 days post last dose.
Pharmacokinetics parameter - multiple doses of KS101 effects on Area under the curve (AUC).
Time frame: Through to 7 days post last dose.
Pharmacokinetics parameter - single dose of KS101 effects on time for maximum observed Concentration (Tmax).
Time frame: Through to 7 days post last dose.
Pharmacokinetics parameter - multiple doses of KS101 effects on time for maximum observed Concentration (Tmax).
Time frame: Through to 7 days post last dose.
Pharmacokinetics parameter - single dose of KS101 effects on KS101 half-life (t1/2).
Time frame: Through to 7 days post last dose.
Pharmacokinetics parameter - multiple doses of KS101 effects on KS101 half-life (t1/2)
Time frame: Through to 7 days post last dose.
Pharmacokinetics parameter - multiple doses of KS101 effects on its bioavailability (CL/F).
Time frame: Through to 7 days post last dose.
Pharmacokinetics parameter - single dose of KS101 effects on its bioavailability (CL/F).
Time frame: Through to 7 days post last dose.
Pharmacokinetics parameter - multiple doses of KS101 effects on the apparent volume of distribution (Vz/F).
Time frame: Through to 7 days post last dose.
Pharmacokinetics parameter - single dose of KS101 effects on the apparent volume of distribution (Vz/F).
Time frame: Through to 7 days post last dose.
Pharmacokinetics parameter - multiple doses of KS101 effects on the apparent elimination rate constant (KEL).
Time frame: Through to 7 days post last dose.
Pharmacokinetics parameter - single dose of KS101 effects on the elimination rate constant (KEL).
Time frame: Through to 7 days post last dose.
Pharmacokinetics parameter - multiple doses of KS101 effects on the accumulation index (RAC).
Time frame: Through to 7 days post last dose.
Investigate the dose proportionality of multiple doses of KS101 on untransformed Cmax.
Time frame: Through to Day 5.
Investigate the dose proportionality of multiple doses of KS101 on area under the curve (AUC).
Time frame: Through to Day 5.
investigate the dose proportionality of single doses of KS101 on untransformed CMAX.
Time frame: Through to end of study, up to 63 days.
investigate the dose proportionality of single doses of KS101 on the area under the curve (AUC).
Time frame: Through to end of study, up to 63 days.
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 27 Aug 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.
Hyunjong Sung contact
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 Part 1 KS101, Part 2 with Food and Part 2 without food in people with Healthy Participants and Alzheimer Disease, run by Klotho Sciences Australia Pty Ltd. at 1 site in Australia.
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 17 inclusion and 22 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 27 Aug 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 Australia. 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 Dr Youn Hoon Joo (+82 10 4879 6001, drjoo@klothosciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety and tolerability of single and multiple ascending oral doses of KS101 in healthy adult volunteers. (time frame: Through to end of study, up to 63 days.). The study lists 8 primary outcomes in all. 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 27 Aug 2025.