Actively Recruiting
A Phase 1 Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetics of AS-S603 in Healthy Participants
Led by Amyloid Solution Inc · Updated on 2026-05-11
88
Participants Needed
1
Research Sites
105 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Phase 1 Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetics of AS-S603 in Healthy Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy Korean adults aged 19 to 50 years for single dose study
- Healthy Korean or Caucasian adults aged 19 to 50 years for multiple dose groups 1-4
- Healthy elderly Korean volunteers aged 65 to 85 years for multiple dose group 5
- Body weight between 50.0 kg and 90.0 kg
- Body mass index between 18.5 kg/m2 and 29.9 kg/m2
- Voluntary written consent and agreement to follow study precautions
You will not qualify if you...
- History or presence of significant disease in hepatobiliary, renal, nervous, immune, respiratory, endocrine, hemato-oncology, cardiovascular, urinary, or psychiatric systems
- History of gastrointestinal disorder or surgery affecting drug evaluation
- Positive response to Columbia Suicide Severity Rating Scale
- Hypersensitivity or allergy to AS-S603 or similar drugs
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis
- History of drug abuse or positive drug screening
- Abnormal vital signs outside specified blood pressure ranges
- Abnormal electrocardiogram findings including prolonged QTcB interval
- Elevated liver enzymes or reduced kidney function
- Recent use of prescription, herbal, OTC drugs, or supplements prior to dosing
- Recent use of drug metabolic enzyme inducers or inhibitors
- Participation in other clinical trials or blood donation within specified timeframes
- Current smoking
- Persistent alcohol consumption or inability to avoid alcohol during study
- Excessive caffeine or inability to avoid caffeine during study
- Consumption or inability to avoid grapefruit products during study
- Unusual dietary habits or inability to follow standardized diet during confinement
- Women of childbearing potential not using effective contraception
- Men not agreeing to use condoms and ensure partners use contraception
- Not agreeing to refrain from donating sperm or eggs during and 90 days after trial
- Inability to undergo cerebrospinal fluid tapping if required
- Other investigator-determined reasons for ineligibility
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Seoul National University Hospital Clinical Trial Center
Seoul, South Korea
Actively Recruiting
Research Team
I
In Young Chang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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