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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 85
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Republic of Korea
Seoul National University Hospital Clinical Trial Center
RECRUITING
Seoul
Contact Information
Primary
In Young Chang
clinical@amyloidsolution.com
+82-31-8092-3840
Time Frame
Start Date: 2025-05-26
Estimated Completion Date: 2026-07
Participants
Target number of participants: 88
Treatments
Experimental: Test group (AS-S603)
Korean and Caucasian Participants
Placebo_comparator: Placebo group (Placebo of AS-S603)
Korean and Caucasian Participants
Related Therapeutic Areas
Sponsors
Leads: Amyloid Solution Inc

This content was sourced from clinicaltrials.gov