Single Ascending Dose Study of ATH-097 in Healthy Participants

NCT07640269 | Not Yet Recruiting Phase 1

• 1 other identifier: ATH-097-101
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

This is a Phase I Study Conducted in Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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

  8 days after single dose

Secondary Outcomes (3)

• To evaluate the pharmacokinetics (PK) of a single dose of ATH-097 in healthy participants.

  Up to 96 hours post dose.

• To evaluate the pharmacokinetics (PK) of a single dose of ATH-097 in healthy participants.

  Up to 96 hours post dose

• To evaluate the pharmacokinetics (PK) of a single dose of ATH-097 in healthy participants.

  Up to 96 hours post dose

Study Arms (2)

ATH-097

EXPERIMENTAL

Drug: ATH-097

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ATH-097 DRUG

Oral Suspension, 6 dose levels

ATH-097

Placebo DRUG

Oral Suspension: Dosing volume identical to the experimental arm

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Atheron Therapeutics, Ltd.: lead

Study Sites (1)

Nucleus Network Pty Ltd.

Melbourne, Victoria, 3004, Australia

Location

Central Study Contacts

Tao Wu

CONTACT

8613671827233; wutao@atheronmed.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 10, 2026
• Study Start: July 6, 2026
• Primary Completion (Estimated): October 20, 2026
• Study Completion (Estimated): October 20, 2026
• Last Updated: June 10, 2026

Record last verified: 2026-06

Locations

AU (1)