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Tests treatment safety and results for Healthy Subjects (HS)
Official title A Phase 1, Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISM8969
ClinicalTrials.gov ID: NCT07581431
What this study is testing
- What it's testing
- This is a single center, phase 1, randomized, double-blind, placebo-controlled sequential study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending oral doses of ISM8969 in healthy adults and elderly participants and obese adult participants at risk of cardiovascular disease.
- 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 18 to 80. Healthy volunteers may be eligible.
You may be able to join if
- Participants must meet all the following criteria to be included in the study: 1\~4 are only for the healthy participants in the SAD and MAD study:
- Male or female participants, including adult participants (≥18 and \<65 years of age) for the SAD cohorts 1-6 and MAD cohorts 1-3, and elderly...
- Body mass index (BMI) \>18.5 and \<30.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females.
- Non-smokers (no use of tobacco or nicotine products within 1 month prior to screening).
- Healthy as defined the current protocol. 5\~9 are only for the obese participants at risk of cardiovascular disease in MAD study):
You likely can't join if
- Participants for whom any of the following applies will be excluded from the study:
- Columbia suicide severity rating scale (C-SSRS) score above Type 1 ideation.
- Positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antigen...
- Positive pregnancy test or lactating female participant.
- History of any central nervous system (CNS) disorder or history of seizure of any cause.
- Clinically significant 12-lead ECG, physical examination, vital signs or laboratory abnormalities at screening, including but not limited to defined...
See the full eligibility criteria
- Participants must meet all the following criteria to be included in the study: 1\~4 are only for the healthy participants in the SAD and MAD study:
- Male or female participants, including adult participants (≥18 and \<65 years of age) for the SAD cohorts 1-6 and MAD cohorts 1-3, and elderly participants (≥65 and ≤80 years of age) for MAD cohort 4.
- Body mass index (BMI) \>18.5 and \<30.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females.
- Non-smokers (no use of tobacco or nicotine products within 1 month prior to screening).
- Healthy as defined the current protocol. 5\~9 are only for the obese participants at risk of cardiovascular disease in MAD study):
- Male or female, ≥18 and ≤65 years of age.
- 30.0 kg/m2 ≤ BMI \< 42.0 kg/m2.
- No change in body weight or self-reported change of less than 5.0% within 3 months before screening.
- Presence of 1 or more risk factors for cardiovascular disease such as hypertension, hyperlipidemia. If present, must be controlled with stable medication dose/therapy (defined as a stable medication dose/therapy for 3...
- hsCRP ≥3 mg/L.
- Participants for whom any of the following applies will be excluded from the study:
- Columbia suicide severity rating scale (C-SSRS) score above Type 1 ideation.
- Positive serology test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antigen and antibody, treponema pallidum antibody or QuantiFERON®-TB test at...
- Positive pregnancy test or lactating female participant.
- History of any central nervous system (CNS) disorder or history of seizure of any cause.
- Clinically significant 12-lead ECG, physical examination, vital signs or laboratory abnormalities at screening, including but not limited to defined in the protocol.
- History of significant cardiovascular or cerebrovascular disease within 6 months before screening, including but not limited to defined in the protocol.
- History of an active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal- or squamous-cell skin cancer, or in situ carcinomas of the cervix) for less than 5 years; or...
- Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days (or 5 half-lives, whichever is longer) prior to the first dosing, administration of...
- Presence of contraindication to lumbar puncture or lumbar catheter as judged by Investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Melbourne, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 18 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Melbourne, Victoria, Australia. 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.