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Phase 1 Study of Epetraborole Tablets

NCT04892641 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2024-03-21

No results posted yet for this study

Summary

This is a Phase 1b double-blind, placebo-controlled, dose-ranging study to evaluate the safety, tolerability, PK, and food effect of epetraborole tablets administered to healthy adult subjects for up to 28 days.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Epetraborole

Epetraborole hydrochloride 250 mg tablets for oral administration

DRUG

Placebo

Matching placebo for 250 mg epetraborole hydrochloride tablets for oral administration

Sponsors & Collaborators

  • AN2 Therapeutics, Inc

    lead INDUSTRY

Principal Investigators

  • Angela Molga, M.D. · CMAX Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-10
Primary Completion
2022-02-26
Completion
2022-02-26
FDA Drug
Yes

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04892641 on ClinicalTrials.gov