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A Study of the Early Effects, Safety, and Acceptability of Oral Alpibectir in Combination With Ethionamide

NCT06748937 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-03-07

No results posted yet for this study

Summary

A multi-centre, randomized, open-label clinical trial. All treatments will be administered orally (PO) on days 1-14.

15 participants will be recruited into each treatment arm in two sequential cohorts. Each cohort will have participants enrolled onto the experimental regimen(s) or the standard of care (SOC; HRZE) control arm.

• Cohort 1 aims to generate safety data for a higher dose of alpibectir plus ethionamide 125 mg and 250 mg (arm 1: A45E125 and arm2: A45E250).

Once 5 participants have enrolled into arms 1 and 2 each, and completed 14 days of treatment, an interim safety review will be conducted to determine whether the study can advance to cohort 2.

• Cohort 2 will investigate safety of alpibectir and ethionamide (A45E250) in combination with rifampicin, pyrazinamide and ethambutol (A45E250RZE).

Participants on HRZE will serve as control for the EBA quantitative mycobacteriology in each cohort, and additionally as a safety benchmark for the A45E250RZE arm. The study is not statistically powered to make between arm comparisons of activity or safety. The treatment will not be blinded but the mycobacteriology laboratory staff performing the endpoint assays will remain blinded until analysis of the EBA results.

Conditions

Interventions

DRUG

Alpibectir 45 mg once daily (OD) plus Ethionamide 125 mg OD

Cohort 1 Arm 1

DRUG

Alpibectir 45 mg OD plus Ethionamide 250 mg OD

Cohort 1 Arm 2

DRUG

Isoniazid, rifampicin, pyrazinamide and ethambutol fixed dose combination, weight based

Active Comparator

DRUG

Alpibectir 45 mg OD plus Ethionamide 250 mg OD plus Rifampicin 10 mg/kg OD plus Ethambutol 20 mg/kg OD plus Pyrazinamide 25 mg/kg OD

Cohort 2 Arm 4

Sponsors & Collaborators

  • Innovative Medicines Initiative

    collaborator OTHER

  • TASK Applied Science

    lead OTHER

Principal Investigators

  • Gifty Okyere-Manu, MBChB · TASK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-03
Primary Completion
2026-03-30
Completion
2026-03-30

Countries

  • South Africa

Study Locations

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Entities

Diseases

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 NCT06748937 on ClinicalTrials.gov