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Healthy VolunteersPhase 1NCT07024589

First-in-Human Trial of Oral AN2-502998

A Phase 1 study testing AN2-502998 in people with Healthy Volunteers, run by AN2 Therapeutics, Inc at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
AN2-502998
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
72 participants
Where
1 siteAustralia
Study dates
4 Aug 2025to 14 Mar 2026
Phase
Phase 1
Are there results?
None posted in the registry

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

  • 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
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  • Have negative results for pregnancy tests performed as follows:
  • Urine specimen obtained during Screening, and ii. Serum specimen obtained on Study Day -1
  • 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:
  • Partner(s) using an IUD
  • Partner(s) using oral, injected, or implanted methods of hormonal contraceptives
  • Partner(s) with bilateral tubal occlusion
  • Total abstinence from sexual intercourse as the preferred lifestyle of the participant; periodic abstinence is not acceptable
  • If male, must agree to use a male condom during intercourse to avoid potential drug exposure to the partner up to 90 days after the last dose of study drug, starting with Study Day 1
  • If female, must agree to use a male condom during heterosexual intercourse to avoid potential drug exposure to the partner up to 90 days after the last dose of study drug, starting with Study Day 1
  • Agree to not donate sperm (males) or ova (females) from Screening until 90 days after the last dose of study drug
  • Medically healthy with no significant clinical medical history, physical examination findings, laboratory results, vital signs, or 12-lead ECG findings, as deemed by the Investigator (or delegate)

Who cannot join

  • History of significant sensitivity to any drug, including any excipients used in AN2-502998
  • Requirement for any over-the-counter and/or prescription medication, vitamins and/or herbal supplements
  • Use of any medications (prescription or over-the-counter), vitamins, and/or herbal supplements within the 2-week period prior to the first dose of study drug administration or within 5 half-lives of the respective medication, whichever is longer
  • Receipt of any drug by injection, including vaccinations, within 30 days (for vaccinations) or a period defined by 5 half-lives, whichever is longer, prior to study drug administration
  • If female, is pregnant or breastfeeding
  • Positive test result for HBsAg, HCV Ab, HIV Ab, or HIV Ag at Screening; negative HIV status will be confirmed at Screening
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  • ALT, AST, or total bilirubin with direct bilirubin >ULN for the reference laboratory at Screening
  • CrCl (Cockcroft-Gault formula), Hgb, Hct, WBC, neutrophil, or platelet count <LLN for the reference laboratory at Screening, unless deemed not CS by the Investigator
  • Fasting glucose ≥5.6 mmol/L
  • QTcF interval duration >450 msec for females or >430 msec for males at Screening
  • Recent (3-month) history of drug or alcohol abuse that could preclude adherence to the protocol
  • History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer, or 1.5 ounces [45 mL] of hard liquor) within 6 months prior to Screening
  • Positive screen for drugs of abuse, alcohol, or cotinine at Screening and Study Day -1
  • History of seizures, diabetes, or cancer (except basal cell carcinoma of the skin)
  • Current clinically significant cardiovascular, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic, neurologic or thyroid disease, or any uncontrolled medical illness or psychiatric disease or disorder
  • Past history of epilepsy; any clinically significant cardiovascular, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic, neurologic, or thyroid disease; or any uncontrolled medical illness or psychiatric disease or disorder
  • History of gastric surgery, vagotomy, bowel resection, cholecystectomy, or any surgical procedure or medical condition that might interfere with gastrointestinal motility, pH, or absorption
  • Donation or loss of 550 mL or more blood volume (including plasmapheresis) within 4 weeks prior to study drug administration or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration
  • Receipt of any investigational product within a period equal to 10 half-lives of the product, if known, or a minimum of 6 weeks prior to study drug administration
  • Consumption of alcohol within the 72 hours prior to study drug administration
  • Consumption of grapefruit, star fruit, Seville oranges, or products containing any of these ingredients within the 10-day period prior to study drug administration
  • Use of inhaled nicotine, tobacco, or marijuana products within the 6 months prior to study drug administration
  • Current enrollment in another clinical trial

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Nucleus Network

    Melbourne, Victoria, 3004

Other trials in Australia

About this study

Official title: A 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

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

Read the detailed description

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

Part A (SAD; Groups SAD1-SAD6):

Part A is the Single Ascending Dose (SAD) portion of the trial that will be conducted in approximately 48 healthy adults in approximately 6 groups. Eight participants in each group will be randomized in a 6:2 ratio to receive a single dose of AN2-502998 or matching PBO, respectively (6 AN2-502998:2 PBO).

Part B (MAD; Groups MAD1-MAD3):

Part B is the Multiple Ascending Dose (MAD) portion of the trial that will be conducted in approximately 24 healthy adults in approximately 3 groups. Eight participants in each group will be randomized in a 6:2 ratio to receive multiple doses of AN2-502998 or matching PBO (6 AN2 502998:2 PBO) QD for 10 days.

Being tested
AN2-502998, Placebo
Keywords
AN15368, AN2-502998, AN2 Therapeutics, Benzoxaborole, Boron, Chagas disease, Healthy Volunteer, Phase 1, Trypanosoma cruzi, T. cruzi
Medical subject headings
Chagas Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AN2-502998Drug

    Oral Capsule

  • PlaceboDrug

    Oral Capsule

Study groups in NCT07024589
Study groupRoleWhat they receive
Single Ascending Dose (SAD)ExperimentalParticipants will be randomized in a 3:1 ratio to receive a single dose of either AN2-502998 or placebo.
Receives: Drug: AN2-502998; Drug: Placebo
Multiple Ascending Dose (MAD)ExperimentalParticipants will be randomized in a 3:1 ratio to receive multiple doses of either AN2-502998 or placebo.
Receives: Drug: AN2-502998; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Incidence, relatedness, and severity of adverse events

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

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

    Incidence of physical exam abnormalities

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

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

    Incidence of changes in blood pressure, pulse, respiratory rate, and temperature

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

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

    Incidence of changes in 12-lead ECG parameters from baseline

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

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

    Incidence of changes in clinical laboratory measurements from baseline

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

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

    Incidence, relatedness, and severity of adverse events

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

  7. Evaluate Physical Examination Abnormalities from Baseline Through Study Completion for Multiple Doses

    Incidence of physical exam abnormalities

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

  8. Evaluate Change in Vital Signs from Baseline Through Study Completion for Multiple Doses

    Incidence of changes in blood pressure, pulse, respiratory rate, and temperature

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

  9. Evaluate Changes in 12-lead ECG Measurements from Baseline Through Study Completion for Multiple Doses

    Incidence of changes in 12-lead ECG parameters from baseline

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

  10. Evaluate Changes in Clinical Laboratory Tests from Baseline Through Study Completion for Multiple Doses

    Incidence of changes in clinical laboratory measurements from baseline

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

  11. Characterize the PK Profile of AN2-502998: Maximum Plasma Concentration

    Determination of the maximum plasma concentration (Cmax)

    Measured: Day 1 through last follow-up (3 Days after last dose)

  12. Characterize the PK Profile of AN2-502998: Time to Maximum Plasma Concentration

    Determination the time to maximum plasma concentration (Tmax)

    Measured: Day 1 through 3 days after last dose

  13. Characterize the PK Profile of AN2-502998: Terminal Half-Life

    Determine the apparent terminal half-life (t½)

    Measured: Day 1 through 3 days after last dose

  14. Characterize the PK Profile of AN2-502998: Area Under Plasma Concentration Curve

    Area under plasma concentration-time curve from zero to a designated dosing interval

    Measured: Day 1 through 3 days after last dose

  15. Characterize the PK Profile of AN2-502998: Apparent Plasma Clearance

    Apparent plasma clearance of drug after extravascular administration CL/F

    Measured: Day 1 through 3 days after last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2025
  2. Study start4 Aug 2025
  3. Primary completion14 Mar 2026
  4. Study completion14 Mar 2026

Resources

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
Basic science
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07024589
Sponsor's protocol ID
998-101
Status last verified
Apr 2026
First submitted
31 May 2025
Last updated
30 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AN2-502998 in people with Healthy Volunteers, run by AN2 Therapeutics, Inc 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 17 inclusion and 23 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: finished, as of the sponsor's last update on 30 Apr 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the Incidence of Treatment Emergent Adverse Events at Baseline and Through Study Completion for a Single Dose (time frame: Day 1 through last follow-up (9 Days after single dose)). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07024589.

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 30 Apr 2026.

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