HealthyPhase 1NCT06786676
A Phase 1 Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetics of AS-S603 in Healthy Participants
A Phase 1 study testing AS-S603 in people with Healthy, run by Amyloid Solution Inc at 1 site in South Korea.
Trial summary
This trial is a randomized, double-blind, placebo-controlled, single- and multiple-oral administration, phase 1 clinical trial to investigate the safety, tolerability, and pharmacokinetics of AS-S603 in healthy Korean or Caucasian adults and Korean elderly people. Read more about this study
- Who is it for?
- Ages 19 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AS-S603
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 May 2025to 31 May 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 19 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Korean adult volunteers aged 19 to 50 years at the time of screening (single dose study)
- Healthy Korean or Caucasian adult volunteers aged 19 to 50 years at the time of screening (multiple dose study dose groups 1-4)
- Healthy elderly Korean volunteers aged 65 to 85 years at the time of screening (multiple dose study dose group 5)
- Individuals with a body weight of ≥ 50.0 kg and ≤ 90.0 kg and a body mass index of ≥ 18.5 kg/m2 and ≤ 29.9 kg/m2 at the time of screening
- Individuals who have given written consent on a voluntary decision to participate and agree to adhere to the precautions after being fully informed of and completely understanding this clinical trial
Who cannot join
- Individuals with a clinically significant disease or history in hepatobiliary, renal, nervous, immune, respiratory, endocrine, hemato-oncology, cardiovascular, urinary system, or psychiatric disorder.
- Individuals with a history of a gastrointestinal disorder or surgery that may affect the safety, pharmacokinetic and pharmacodynamic evaluation of the investigational product
- Individuals who answered 'yes' to any question on the Columbia Suicide Severity Rating Scale administered at the time of screening
- Individuals with hypersensitivity or a history of clinically significant hypersensitivity to AS-S603 and the same class or other drugs (aspirin, antibiotics, etc.)
- Individuals with a positive result in the serology test (hepatitis B, hepatitis C, human immunodeficiency virus test, syphilis test)
- Individuals with a history of drug abuse or a positive urine screening for any drug of concern for abuse
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- Individuals who exhibited the following results on vital signs measured at a sitting position after resting, during the screening tests: Systolic blood pressure < 80 mmHg or ≥ 140 mmHg, Diastolic blood pressure < 45 mmHg or ≥ 90 mmHg
- Individuals who exhibited QTcB interval > 450 msec (male), 470 msec (female), or clinically significant abnormal findings in rhythm on an electrocardiogram during the screening tests
- Individuals who exhibited any of the following results on the clinical laboratory test during the screening tests, including additional tests: Aspartate transaminase or alanine transaminase > 60 IU/L, Estimated glomerular filtration rate < 90 mL/min/1.73m2
- Individuals who had taken any prescription drug or herbal medicine within 2 weeks, or any Over-The-Counter (OTC) drugs, dietary supplements including liver supplements, or vitamin supplements within 1 week prior to the scheduled first administration of investigational product, or are expected to take them
- Individuals who had taken an inducer or inhibitor of any drug metabolic enzyme, such as barbiturates or clarithromycin, within 1 month prior to the scheduled first administration of investigational product
- Individuals who have participated and administered investigational product in another clinical trial within 6 months prior to the scheduled first administration of investigational product
- Individuals who donated whole blood within 2 months, donated blood components within 1 month, or received a blood transfusion within 1 month prior to the scheduled first administration of investigational product
- Current smokers
- Individuals who engage in persistent alcohol consumption or are not able to avoid alcohol consumption from 3 days prior to the scheduled first administration of investigational product until the end of the clinical trial.
- Individuals who have consumed excessive caffeine or are not able to avoid consuming caffeine-containing foods from 3 days prior to the scheduled first administration of investigational product until the end of the clinical trial.
- Individuals who have consumed grapefruit, grapefruit juice, or grapefruit-containing foods or cannot avoid consuming grapefruit-containing foods from 3 days prior to the scheduled first administration of investigational product until the end of the clinical trial.
- Individuals with unusual dietary habits or who cannot adhere to the standardized diet provided by the institution during the confinement period.
- Women of childbearing potential, individuals whose menstrual period was not confirmed at screening, with a positive urine pregnancy test, or who do not agree to a highly effective contraceptive method for at least 30 days after the last investigational product administration.
- Men who do not agree to use condoms and ensure that their female partners use a highly effective contraceptive method throughout the entire clinical trial period and for at least 90 days after the last administration of investigational product.
- Individuals who do not agree to refrain from donating sperm or egg throughout the entire clinical trial period and for at least 90 days after the last administration of investigational product.
- Individuals who cannot undergo cerebrospinal fluid (CSF) tapping (for groups requiring CSF tapping)
- Individuals determined to be ineligible for participation in the clinical trial by the investigators due to other reasons
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital Clinical Trial Center
Seoul
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single- and Multiple-oral Administration, Phase 1 Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetics of AS-S603 in Healthy Korean or Caucasian Adults and Korean Elderly People
This trial is a randomized, double-blind, placebo-controlled, single- and multiple-oral administration, phase 1 clinical trial to investigate the safety, tolerability, and pharmacokinetics of AS-S603 in healthy Korean or Caucasian adults and Korean elderly people.
AS-S603 is an orally administered agent developed by Amyloid Solution Inc to treat Alzheimer's disease (AD). It is a small molecule compound that targets and dissolves amyloid-beta (Aβ) and tau aggregates, two key pathologies present in the extracellular and intracellular spaces of brain cells in AD.
- Conditions
- Healthy
- Being tested
- AS-S603, Placebo
- Keywords
- AD, Alzheimer Disease, AS-S603, Mild Cognitive Impairment
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AS-S603Drug
Oral administration of AS-S603 tablet
PlaceboDrug
Oral administration of Placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Test group (AS-S603) | Experimental | Korean and Caucasian Participants Receives: Drug: AS-S603 |
| Placebo group (Placebo of AS-S603) | Placebo comparator | Korean and Caucasian Participants Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events (AEs)
Measured: Up to Day 27
Maximum observed concentration (Cmax)
Measured: Up to Day 18
Time of maximum observed concentration (Tmax)
Measured: Up to Day 18
Terminal half-life (t1/2)
Measured: Up to Day 18
Area under the concentration-time curve from the time of dosing to the time of the last measurable concentration (AUClast)
Measured: Up to Day 18
Area under the concentration-time curve from the time of dosing extrapolated to infinity (AUCinf)
Measured: Up to Day 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start26 May 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amyloid Solution Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06786676
- Sponsor's protocol ID
- AS-S603-P101
- Status last verified
- May 2026
- First submitted
- 8 Jan 2025
- Last updated
- 11 May 2026
- 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 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single- and Multiple-oral Administration, Phase 1 Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetics of AS-S603 in Healthy Korean or Caucasian Adults and Korean Elderly People
- ClinicalTrials.gov ID
- NCT06786676
- Acronym / sponsor ID
- AS-S603-P101
- Conditions
- Healthy
- Keywords
- AD, Alzheimer Disease, AS-S603, Mild Cognitive Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Amyloid Solution IncIndustry (pharma, biotech, devices)
- Study start
- 26 May 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 22 Jan 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 trial is a randomized, double-blind, placebo-controlled, single- and multiple-oral administration, phase 1 clinical trial to investigate the safety, tolerability, and pharmacokinetics of AS-S603 in healthy Korean or Caucasian adults and Korean elderly people.
AS-S603 is an orally administered agent developed by Amyloid Solution Inc to treat Alzheimer's disease (AD). It is a small molecule compound that targets and dissolves amyloid-beta (Aβ) and tau aggregates, two key pathologies present in the extracellular and intracellular spaces of brain cells in AD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group (AS-S603) | Experimental | Drug: AS-S603Korean and Caucasian Participants |
| Placebo group (Placebo of AS-S603) | Placebo comparator | Drug: PlaceboKorean and Caucasian Participants |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy Korean adult volunteers aged 19 to 50 years at the time of screening (single dose study)
- Healthy Korean or Caucasian adult volunteers aged 19 to 50 years at the time of screening (multiple dose study dose groups 1-4)
- Healthy elderly Korean volunteers aged 65 to 85 years at the time of screening (multiple dose study dose group 5)
- Individuals with a body weight of ≥ 50.0 kg and ≤ 90.0 kg and a body mass index of ≥ 18.5 kg/m2 and ≤ 29.9 kg/m2 at the time of screening
- Individuals who have given written consent on a voluntary decision to participate and agree to adhere to the precautions after being fully informed of and completely understanding this clinical trial
Key exclusion criteria (23 listed)
- Individuals with a clinically significant disease or history in hepatobiliary, renal, nervous, immune, respiratory, endocrine, hemato-oncology, cardiovascular, urinary system, or psychiatric disorder.
- Individuals with a history of a gastrointestinal disorder or surgery that may affect the safety, pharmacokinetic and pharmacodynamic evaluation of the investigational product
- Individuals who answered 'yes' to any question on the Columbia Suicide Severity Rating Scale administered at the time of screening
- Individuals with hypersensitivity or a history of clinically significant hypersensitivity to AS-S603 and the same class or other drugs (aspirin, antibiotics, etc.)
- Individuals with a positive result in the serology test (hepatitis B, hepatitis C, human immunodeficiency virus test, syphilis test)
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 |
|---|---|---|
| AS-S603Oral administration of AS-S603 tablet | Drug | Test group (AS-S603) |
| PlaceboOral administration of Placebo tablet | Drug | Placebo group (Placebo of AS-S603) |
Primary outcome
Number of adverse events (AEs)
Time frame: Up to Day 27
Maximum observed concentration (Cmax)
Time frame: Up to Day 18
Time of maximum observed concentration (Tmax)
Time frame: Up to Day 18
Terminal half-life (t1/2)
Time frame: Up to Day 18
Area under the concentration-time curve from the time of dosing to the time of the last measurable concentration (AUClast)
Time frame: Up to Day 18
Area under the concentration-time curve from the time of dosing extrapolated to infinity (AUCinf)
Time frame: Up to Day 18
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 11 May 2026.
- 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 AS-S603 in people with Healthy, run by Amyloid Solution Inc at 1 site in South Korea.
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 5 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 11 May 2026. 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 South Korea. 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 In Young Chang (+82-31-8092-3840, clinical@amyloidsolution.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events (AEs) (time frame: Up to Day 27). The study lists 6 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 11 May 2026.