This is a Phase I Study Conducted in Healthy VolunteersPhase 1NCT07640269
Single Ascending Dose Study of ATH-097 in Healthy Participants
A Phase 1 study testing ATH-097 in people with This is a Phase I Study Conducted in Healthy Volunteers, run by Atheron Therapeutics, Ltd. at 1 site in Australia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- This is a Phase I Study Conducted in Healthy Volunteers
- What is being tested?
- ATH-097
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteAustralia
- Study dates
- 6 Jul 2026to 20 Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
- 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.
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- 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.
- Have any of the following active or recent infections:
- serious infection requiring hospitalization or parenteral antibiotics within 12 weeks prior to Day 1, serious bone/joint infection within 24 weeks, or history of infection of an artificial joint;
- active herpes simplex or herpes zoster outbreak within 12 weeks prior to Day 1;
- active infection requiring systemic antimicrobial treatment within 4 weeks prior to Day 1, or superficial skin infection requiring antibiotics within 1 week prior to Day 1;
- active TB; or (e) immunocompromised status posing unacceptable risk per investigator judgment.
- Have chronic hepatitis B, defined as positive hepatitis B surface antigen (HBsAg) or detectable hepatitis B virus (HBV) DNA at screening. Note: Participants who are hepatitis B core antibody (HBcAb) positive and HBV DNA undetectable may be eligible.
- Have hepatitis C infection, defined as positive hepatitis C antibody (HCV Ab) with detectable HCV RNA. Participants with a history of hepatitis C treatment with undetectable HCV RNA at least 24 weeks after completion of treatment may be eligible.
- Have a history of human immunodeficiency virus (HIV) infection or be positive for HIV at screening.
- Have active or untreated syphilis infection, defined as a reactive Toluidine Red Unheated Serum Test (TRUST) or Treponema pallidum antibody (TP Ab) positive at screening.
- Have known or suspected intolerance or hypersensitivity to any components of the formulation of ATH-097 and its excipients.
- Have a history of drug abuse or addiction within 6 months of screening.
- Have consumed more than 14 units of alcohol per week on average within 3 months prior to Day 1, or be unwilling to abstain completely from alcohol consumption from 7 days prior to Day 1 through discharge.
- Be a current smoker defined as smoking more than 5 cigarettes (or equivalent nicotine-containing products) per week within the 6 months prior to Day 1, or have a positive urine cotinine test at Screening or Day -1.
- Consume more than 5 cups of coffee, tea, or other caffeine-containing beverages per day on average within 3 months prior to Day 1, or be unwilling to abstain from all caffeine-containing products from 48 hours prior to Day 1 through discharge.
- Have received live or attenuated vaccine(s) within 12 weeks prior to screening or plan to receive such vaccines during the study.
- Have received biologic immunomodulatory agents within 3 months or 5 half-lives (whichever is longer) prior to dosing.
- Have donated blood (excluding plasma donations) of approximately 1 pint (500 mL) or more within 30 days prior to Screening.
- Have received a transfusion of blood or blood products within 30 days prior to Day 1 dosing.
- If female, be nursing, lactating, pregnant, or planning to become pregnant within 94 days after the last dose of IP.
- Have used any prescription or over-the-counter (OTC) medications, herbal preparations, dietary supplements, or vitamins that may affect the metabolism or pharmacokinetics of ATH-097 within 14 days or 5 half-lives (whichever is longer) prior to Day 1.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site
Nucleus Network Pty Ltd.
Melbourne, Victoria, 3004
Dr Ryan, (03) 8593 9801, p.ryan@nucleusnetwork.com.au
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ATH-097 in Healthy Participants
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
- Being tested
- ATH-097, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATH-097Drug
Oral Suspension, 6 dose levels
PlaceboDrug
Oral Suspension: Dosing volume identical to the experimental arm
| Study group | Role | What they receive |
|---|---|---|
| ATH-097 | Experimental | Not described Receives: Drug: ATH-097 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number and severity of treatment emergent adverse events (TEAEs)
The incidence, severity, and relationship to IP of AEs. Change from Baseline in clinical laboratory parameters, physical examination findings, vital signs, and 12-lead ECG
Measured: 8 days after single dose
Secondary outcomes (3)
To evaluate the pharmacokinetics (PK) of a single dose of ATH-097 in healthy participants.
Peak plasma Concentration (Cmax)
Measured: Up to 96 hours post dose.
To evaluate the pharmacokinetics (PK) of a single dose of ATH-097 in healthy participants.
Area under the drug concentration-time curve (AUC)
Measured: Up to 96 hours post dose
To evaluate the pharmacokinetics (PK) of a single dose of ATH-097 in healthy participants.
Apparent terminal half-life (t½)
Measured: Up to 96 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start6 Jul 2026 (estimated)
- Primary completion20 Oct 2026 (estimated)
- Study completion20 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for This is a Phase I Study Conducted in Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atheron Therapeutics, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07640269
- Sponsor's protocol ID
- ATH-097-101
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ATH-097 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07640269
- Acronym / sponsor ID
- ATH-097-101
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Atheron Therapeutics, Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Jul 2026 (estimated)
- Primary completion
- 20 Oct 2026 (estimated)
- Study completion
- 20 Oct 2026 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATH-097 | Experimental | Drug: ATH-097 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (28 listed)
- 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.
- Have experienced major trauma or undergone major surgery within 3 months prior to Day 1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATH-097Oral Suspension, 6 dose levels | Drug | ATH-097 |
| PlaceboOral Suspension: Dosing volume identical to the experimental arm | Drug | Placebo |
Primary outcome
The number and severity of treatment emergent adverse events (TEAEs)
Time frame: 8 days after single dose
The incidence, severity, and relationship to IP of AEs. Change from Baseline in clinical laboratory parameters, physical examination findings, vital signs, and 12-lead ECG
3 secondary outcomes
To evaluate the pharmacokinetics (PK) of a single dose of ATH-097 in healthy participants.
Time frame: Up to 96 hours post dose.
To evaluate the pharmacokinetics (PK) of a single dose of ATH-097 in healthy participants.
Time frame: Up to 96 hours post dose
To evaluate the pharmacokinetics (PK) of a single dose of ATH-097 in healthy participants.
Time frame: Up to 96 hours post dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ATH-097 in people with This is a Phase I Study Conducted in Healthy Volunteers, run by Atheron Therapeutics, Ltd. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tao Wu (8613671827233, wutao@atheronmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number and severity of treatment emergent adverse events (TEAEs) (time frame: 8 days after single dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.