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

NCT ID: NCT06786676

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-26
• Study Completion Date: 2026-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Test group (AS-S603)

Korean and Caucasian Participants

Group Type: EXPERIMENTAL

AS-S603

Intervention Type: DRUG

Oral administration of AS-S603 tablet

Placebo group (Placebo of AS-S603)

Korean and Caucasian Participants

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral administration of Placebo tablet

Interventions

AS-S603

Oral administration of AS-S603 tablet

Intervention Type: DRUG

Placebo

Oral administration of Placebo tablet

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.
• 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Amyloid Solution Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Seoul National University Hospital Clinical Trial Center

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

In Young Chang

Role: CONTACT

clinical@amyloidsolution.com

+82-31-8092-3840

Other Identifiers

AS-S603-P101

Identifier Type: -

Identifier Source: org_study_id