BridgeMD
Tests treatment safety and results for Healthy
Official title A Phase 1 Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetics of AS-S603 in Healthy Participants
ClinicalTrials.gov ID: NCT06786676
What this study is testing
What is AS-S603?
AS-S603 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for healthy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 85. Healthy volunteers may be eligible.
You may be able to join 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...
You likely can't join if
- Individuals with a clinically significant disease or history in hepatobiliary, renal, nervous, immune, respiratory, endocrine, hemato-oncology...
- Individuals with a history of a gastrointestinal disorder or surgery that may affect the safety, pharmacokinetic and pharmacodynamic evaluation of...
- 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...
- 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
See the full eligibility 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
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 85 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.