First-in-Human Trial of Oral AN2-502998

NCT07024589 | Completed Phase 1 DMC

• 1 other identifier: 998-101
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Healthy Volunteers

Keywords

AN15368; AN2-502998; AN2 Therapeutics; Benzoxaborole; Boron; Chagas disease; Healthy Volunteer; Phase 1; Trypanosoma cruzi; T. cruzi

Outcome Measures

Primary Outcomes (15)

• 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

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

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

  Incidence of physical exam abnormalities

  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

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

  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

  Incidence of changes in 12-lead ECG parameters from baseline

  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

  Incidence of changes in clinical laboratory measurements from baseline

  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

  Incidence, relatedness, and severity of adverse events

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

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

  Incidence of physical exam abnormalities

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

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

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

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

• 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

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

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

  Incidence of changes in clinical laboratory measurements from baseline

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

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

  Determination of the maximum plasma concentration (Cmax)

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

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

  Determination the time to maximum plasma concentration (Tmax)

  Day 1 through 3 days after last dose

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

  Determine the apparent terminal half-life (t½)

  Day 1 through 3 days after last dose

• 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

  Day 1 through 3 days after last dose

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

  Apparent plasma clearance of drug after extravascular administration CL/F

  Day 1 through 3 days after last dose

Study Arms (2)

Single Ascending Dose (SAD)

EXPERIMENTAL

Participants will be randomized in a 3:1 ratio to receive a single dose of either AN2-502998 or placebo.

Drug: AN2-502998; Drug: Placebo

Multiple Ascending Dose (MAD)

EXPERIMENTAL

Participants will be randomized in a 3:1 ratio to receive multiple doses of either AN2-502998 or placebo.

Drug: AN2-502998; Drug: Placebo

Interventions

AN2-502998 DRUG

Oral Capsule

Multiple Ascending Dose (MAD); Single Ascending Dose (SAD)

Placebo DRUG

Oral Capsule

Multiple Ascending Dose (MAD); Single Ascending Dose (SAD)

Eligibility Criteria

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

You may qualify if:

• 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:
• i. 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• AN2 Therapeutics, Inc: lead

Study Sites (1)

Nucleus Network

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Chagas Disease

Condition Hierarchy (Ancestors)

Trypanosomiasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2025
• First Posted: June 17, 2025
• Study Start: August 4, 2025
• Primary Completion: March 14, 2026
• Study Completion: March 14, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)