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

NCT06786676 | Recruiting Phase 1

• 1 other identifier: AS-S603-P101
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

AD; Alzheimer Disease; AS-S603; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (6)

• Number of adverse events (AEs)

  Up to Day 27

• Maximum observed concentration (Cmax)

  Up to Day 18

• Time of maximum observed concentration (Tmax)

  Up to Day 18

• Terminal half-life (t1/2)

  Up to Day 18

• Area under the concentration-time curve from the time of dosing to the time of the last measurable concentration (AUClast)

  Up to Day 18

• Area under the concentration-time curve from the time of dosing extrapolated to infinity (AUCinf)

  Up to Day 18

Other Outcomes (1)

• pTau217 concentration and Aβ42/40 ratio in plasma and cerebrospinal fluid (CSF)

  Up to day 27

Study Arms (2)

Test group (AS-S603)

EXPERIMENTAL

Korean and Caucasian Participants

Drug: AS-S603

Placebo group (Placebo of AS-S603)

PLACEBO COMPARATOR

Korean and Caucasian Participants

Drug: Placebo

Interventions

AS-S603 DRUG

Oral administration of AS-S603 tablet

Test group (AS-S603)

Placebo DRUG

Oral administration of Placebo tablet

Placebo group (Placebo of AS-S603)

Eligibility Criteria

• Age: 19 Years - 85 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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.

Sponsors & Collaborators

• Amyloid Solution Inc: lead

Study Sites (1)

Seoul National University Hospital Clinical Trial Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Central Study Contacts

In Young Chang

CONTACT

+82-31-8092-3840; clinical@amyloidsolution.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 22, 2025
• Study Start: May 26, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)