Single Ascending Dose Study of ATH-097 in Healthy Participants (NCT07640269) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Single Ascending Dose Study of ATH-097 in Healthy Participants
Australia44 participantsStarted 2026-07-06
Plain-language summary
This is a Phase I, A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ATH-097 in Healthy Participants
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participants must be able and willing to provide informed consent.
. Participants must be aged 18 to 55 years at the time of consent.
. Participants must have a BMI within the range 18.5 to 29.9 kg/m2.
. Participants must be in general good health.
. All female participants of childbearing potential and all male participants who are able to father children and are sexually active and whose partners are at risk for pregnancy, must agree to use a highly effective method of contraception in combination with a condom from the time of signing the informed consent form through 94 days after the last IP administration.
Exclusion criteria
. Have any condition that, in the investigator's opinion, might jeopardize the participant's safety or compliance with the protocol.
. Have a history of any severe allergic reaction or anaphylaxis.
. Have clinically significant abnormalities in clinical laboratory results, as judged by the Investigator, including estimated glomerular filtration rate (eGFR) \< 90 mL/min/1.73 m² (CKD-EPI 2021 formula).
. Have participated in another interventional clinical trial and received an investigational drug within 28 days (or as determined by local requirements) or 5 half-lives prior to Day 1, whichever is longer, or are currently participating in another interventional clinical trial.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The number and severity of treatment emergent adverse events (TEAEs)
. Have experienced major trauma or undergone major surgery within 3 months prior to Day 1.
. Have a history of malignancy within 5 years before the screening visit, except for curatively treated carcinoma in situ of the cervix or non-metastatic squamous or basal cell carcinoma of the skin.
. Have screening seated blood pressure ≥ 140 mm Hg (systolic) or ≥ 90 mm Hg (diastolic).
. Have a screening 12-lead ECG with clinically relevant abnormalities that may affect the participant's safety or the interpretation of study results.