NCT04550832

PanACEA DElpazolid Dose-finding and COmbination DEvelopment (DECODE)

A Phase IIb, Open Label, Randomized Controlled Dose Ranging Multi-Center Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Exposure-Response Relationship of Different Doses of Delpazolid in Combination With Bedaquiline Delamanid Moxifloxacin in Adult Subjects With Newly Diagnosed, Uncomplicated, Smear-Positive, Drug-sensitive Pulmonary Tuberculosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: LigaChem Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Detailed description

This will be an open label Phase IIb dose-finding, randomized, controlled study with a duration of 16 weeks of experimental therapy of Delpazolid(DZD) - Bedaquiline/Delamanid/ Moxifloxacin (BDM) in adult patients with newly diagnosed, smear positive, uncomplicated, drug sensitive pulmonary tuberculosis (TB) to evaluate the safety, efficacy, tolerability, pharmacokinetics and exposure/response-relationship of different doses of delpazolid in combination with bedaquiline, delamanid and moxifloxacin. Participants will be randomized to one of five arms containing BDM standard dose with different doses of DZD.

Conditions

• Infections and Infestations
• Pulmonary Tuberculosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-10-28
• Primary completion: 2023-01-04
• Completion: 2023-09-11
• First posted: 2020-09-16
• Last updated: 2025-09-16
• Results posted: 2024-10-28

Locations

5 sites across 2 countries: South Africa, Tanzania

Regulatory

• FDA-regulated drug study