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AN2-502998

Phase 1

Healthy Volunteers | Small molecule | Other |AN2 Therapeutics, Inc.|Last Updated: Apr 30, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment72

FDA Designations

No designations recorded

Clinical trial landscape

AN2-502998 · 1 trial · 1 indication

Phase 1 1
NCT07024589First-in-Human Trial of Oral AN2-502998Healthy Volunteers
COMPLETED72 Analytics
PHASE1COMPLETED
First-in-Human Trial of Oral AN2-502998
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Study Endpoints

Primary Endpoints

Evaluate the Incidence of Treatment Emergent Adverse Events at Baseline and Through Study Completion for a Single Dose
Day 1 through last follow-up (9 Days after single dose)

Incidence, relatedness, and severity of adverse events

Evaluate Physical Examination Abnormalities from Baseline Through Study Completion for a Single Dose
Day 1 through last follow-up (9 Days after single dose)

Incidence of physical exam abnormalities

Evaluate Change in Vital Signs from Baseline Through Study Completion for a Single Dose
Day 1 through last follow-up (9 Days after single dose)

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

Evaluate Changes in 12-lead ECG Measurements from Baseline Through Study Completion for a Single Dose
Day 1 through last follow-up (9 Days after single dose)

Incidence of changes in 12-lead ECG parameters from baseline

Evaluate Changes in Clinical Laboratory Tests from Baseline Through Study Completion for a Single Dose
Day 1 through last follow-up (9 Days after single dose)

Incidence of changes in clinical laboratory measurements from baseline

Evaluate the Incidence of Treatment Emergent Adverse Events at Baseline and Through Study Completion for Multiple Doses
Day 1 through last follow-up (10 Days after last dose)

Incidence, relatedness, and severity of adverse events

Evaluate Physical Examination Abnormalities from Baseline Through Study Completion for Multiple Doses
Day 1 through last follow-up (10 Days after last dose)

Incidence of physical exam abnormalities

Evaluate Change in Vital Signs from Baseline Through Study Completion for Multiple Doses
Day 1 through last follow-up (10 Days after last dose)

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

Evaluate Changes in 12-lead ECG Measurements from Baseline Through Study Completion for Multiple Doses
Day 1 through last follow-up (10 Days after last dose)

Incidence of changes in 12-lead ECG parameters from baseline

Evaluate Changes in Clinical Laboratory Tests from Baseline Through Study Completion for Multiple Doses
Day 1 through last follow-up (10 Days after last dose)

Incidence of changes in clinical laboratory measurements from baseline

Characterize the PK Profile of AN2-502998: Maximum Plasma Concentration
Day 1 through last follow-up (3 Days after last dose)

Determination of the maximum plasma concentration (Cmax)

Characterize the PK Profile of AN2-502998: Time to Maximum Plasma Concentration
Day 1 through 3 days after last dose

Determination the time to maximum plasma concentration (Tmax)

Characterize the PK Profile of AN2-502998: Terminal Half-Life
Day 1 through 3 days after last dose

Determine the apparent terminal half-life (t½)

Characterize the PK Profile of AN2-502998: Area Under Plasma Concentration Curve
Day 1 through 3 days after last dose

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

Characterize the PK Profile of AN2-502998: Apparent Plasma Clearance
Day 1 through 3 days after last dose

Apparent plasma clearance of drug after extravascular administration CL/F

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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Single Ascending Dose (SAD)EXPERIMENTALParticipants will be randomized in a 3:1 ratio to receive a single dose of either AN2-502998 or placebo.
Multiple Ascending Dose (MAD)EXPERIMENTALParticipants will be randomized in a 3:1 ratio to receive multiple doses of either AN2-502998 or placebo.

Interventions

NameTypeDescription
AN2-502998DRUGOral Capsule
PlaceboDRUGOral Capsule
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Male or female aged 18 to 55 years, inclusive, at Screening 2. Willing and able to provide written informed consent 3. Willing and able to comply with all trial assessments and adhere to the protocol schedule 4. BMI between ≥18 and \<32 kg/m2 (inclusive); BMI is calculated as...

Countries:Australia
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Frequently asked questions about AN2-502998

What is AN2-502998?

AN2-502998 is an investigational small molecule being developed by AN2 Therapeutics, Inc. (NASDAQ: ANTX). It is currently in Phase 1 clinical development, having completed a first-in-human trial in healthy volunteers. The drug is being studied for its safety, tolerability, and pharmacokinetics.

What is AN2-502998 used for?

AN2-502998 is being studied in healthy volunteers as part of a first-in-human Phase 1 trial. The trial is designed to evaluate the drug's safety, tolerability, and how it is processed by the body. Its intended therapeutic use has not been specified in the available information.

Who makes AN2-502998?

AN2-502998 is being developed by AN2 Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol ANTX. The company is conducting clinical trials to evaluate this investigational small molecule.

What phase is AN2-502998 in?

AN2-502998 is in Phase 1 clinical development. A first-in-human trial of the oral drug has been completed. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is AN2-502998 in?

AN2-502998 has one completed Phase 1 clinical trial, registered as NCT07024589, titled "First-in-Human Trial of Oral AN2-502998." The trial enrolled 72 healthy volunteers in Australia and was randomized, double-blind, and controlled.

Is AN2-502998 the same as any other drug?

No alternative names for AN2-502998 have been disclosed. It is identified solely by its code name AN2-502998 in clinical trial registrations and company communications.