A Phase 1 Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetics of AS-S603 in Healthy Participants
Eligible age
19–85 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
Yes
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About this study
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.
Sponsor: Amyloid Solution Inc
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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
- ✕ 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
Source: ClinicalTrials.gov · NCT06786676 · last updated 2026-05-11