CompletedPhase 1

First-in-Human Trial of Oral AN2-502998

Australia72 participantsStarted 2025-08-04

Plain-language summary

First-in-Human Phase 1, Single-Center, Randomized, Blinded, Placebo-Controlled Trial in Healthy Adults to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of Oral AN2-502998

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

. Male or female aged 18 to 55 years, inclusive, at Screening
. Willing and able to provide written informed consent
. Willing and able to comply with all trial assessments and adhere to the protocol schedule
. BMI between ≥18 and \<32 kg/m2 (inclusive); BMI is calculated as weight measured in kilograms (kg) divided by the square of height measured in meters (m)
. If female, must:
. Be of nonchildbearing potential defined as either postmenopausal for ≥2 years or surgically sterile (bilateral salpingectomy, bilateral oophorectomy, or hysterectomy); postmenopausal is defined as amenorrheic for ≥1 year in the absence of other biological causes, age appropriate, and has a FSH level during Screening indicating a postmenopausal state; AND
. Have negative results for pregnancy tests performed as follows:
. If male and sexually active with a female of childbearing potential, must be surgically sterile or agree to practice at least 1 of the following effective forms of contraception up to 90 days after the last dose of study drug, starting with Study Day 1:

Exclusion criteria

. History of significant sensitivity to any drug, including any excipients used in AN2-502998

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

Evaluate the Incidence of Treatment Emergent Adverse Events at Baseline and Through Study Completion for a Single Dose

Timeframe: Day 1 through last follow-up (9 Days after single dose)

Evaluate Physical Examination Abnormalities from Baseline Through Study Completion for a Single Dose

Timeframe: Day 1 through last follow-up (9 Days after single dose)

Evaluate Change in Vital Signs from Baseline Through Study Completion for a Single Dose

Timeframe: Day 1 through last follow-up (9 Days after single dose)

Evaluate Changes in 12-lead ECG Measurements from Baseline Through Study Completion for a Single Dose

Timeframe: Day 1 through last follow-up (9 Days after single dose)

Evaluate Changes in Clinical Laboratory Tests from Baseline Through Study Completion for a Single Dose

Timeframe: Day 1 through last follow-up (9 Days after single dose)

Evaluate the Incidence of Treatment Emergent Adverse Events at Baseline and Through Study Completion for Multiple Doses

Timeframe: Day 1 through last follow-up (10 Days after last dose)

Trial details

NCT IDNCT07024589

SponsorAN2 Therapeutics, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03-14

View on ClinicalTrials.gov More Healthy Volunteers trials

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

. Male or female aged 18 to 55 years, inclusive, at Screening
. Willing and able to provide written informed consent
. Willing and able to comply with all trial assessments and adhere to the protocol schedule
. BMI between ≥18 and \<32 kg/m2 (inclusive); BMI is calculated as weight measured in kilograms (kg) divided by the square of height measured in meters (m)
. If female, must:
. Be of nonchildbearing potential defined as either postmenopausal for ≥2 years or surgically sterile (bilateral salpingectomy, bilateral oophorectomy, or hysterectomy); postmenopausal is defined as amenorrheic for ≥1 year in the absence of other biological causes, age appropriate, and has a FSH level during Screening indicating a postmenopausal state; AND
. Have negative results for pregnancy tests performed as follows:
. If male and sexually active with a female of childbearing potential, must be surgically sterile or agree to practice at least 1 of the following effective forms of contraception up to 90 days after the last dose of study drug, starting with Study Day 1:

Exclusion criteria

. History of significant sensitivity to any drug, including any excipients used in AN2-502998