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PanACEA DElpazolid Dose-finding and COmbination DEvelopment (DECODE)

NCT04550832 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2025-09-16

Study results available
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Summary

This trial is to describe the safety, tolerability and exposure-toxicity relationship of Depazolid given over 16 weeks, in combination with standard-dose Bedaquiline, Delamanid and Moxifloxacin, compared to standard-dose Bedaquiline, Delamanid and Moxifloxacin alone

Conditions

  • Infections and Infestations
  • Pulmonary Tuberculosis

Interventions

DRUG

Delpazolid

Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.

DRUG

Bedaquiline, Delamanid, Moxifloxacin

These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.

Sponsors & Collaborators

  • Ludwig-Maximilians - University of Munich

    collaborator OTHER

  • Radboud University Medical Center

    collaborator OTHER

  • University of California, San Francisco

    collaborator OTHER

  • LigaChem Biosciences, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-10-28
Primary Completion
2023-01-04
Completion
2023-09-11
FDA Drug
Yes

Countries

  • South Africa
  • Tanzania

Study Locations

More Related Trials

Entities

Companies

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 NCT04550832 on ClinicalTrials.gov