RecruitingPhase 1NCT06786676

A Phase 1 Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetics of AS-S603 in Healthy Participants

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


Sponsor

Amyloid Solution Inc

Enrollment

88 participants

Start Date

May 26, 2025

Study Type

INTERVENTIONAL

Conditions

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. 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.


Eligibility

Min Age: 19 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This is a Phase 1 safety study of a new experimental drug called AS-S603 in healthy volunteers. The goal is to understand how the drug behaves in the body — how it is absorbed, broken down, and cleared — before it is tested in patients. **You may be eligible if...** - You are a healthy adult between 19 and 50 years old (single and multiple dose groups) - You are a healthy elderly person between 65 and 85 years old (for one specific dose group) - You are Korean or Caucasian - Your body weight is between 50 and 90 kg and your BMI is between 18.5 and 29.9 - You have no significant medical conditions **You may NOT be eligible if...** - You have any significant health condition - You are outside the required age or weight range - You do not meet the screening health requirements - You are currently on any medications or have drug/substance use issues Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAS-S603

Oral administration of AS-S603 tablet

DRUGPlacebo

Oral administration of Placebo tablet


Locations(1)

Seoul National University Hospital Clinical Trial Center

Seoul, South Korea

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NCT06786676


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