Safety and Tolerability of Chloroquine Added to Standard 4-Drug Anti-tuberculosis Therapy in Healthy Volunteers An Open Label, Single Center, Phase 1 Dose Escalation and Extension Trial

What this Trial Is About

This trial investigates the safety and tolerability of adding Chloroquine to the standard four-drug anti-tuberculosis therapy in healthy volunteers. Tuberculosis remains a leading cause of death worldwide, and there is a need for new treatment approaches that are shorter, more tolerable, and more effective. Laboratory studies and animal models suggest that Chloroquine may improve the effectiveness of existing TB drugs by increasing their concentration inside cells. Participants receive oral doses combining Chloroquine and the standard anti-TB drug Rimstar for 14 days. The study includes several dosage groups with escalating amounts of Chloroquine alongside Rimstar tablets taken once daily before breakfast. This phase 1, open-label trial evaluates different dose levels to understand safety and drug behavior in the body. During the study, participants undergo detailed physical exams, vital signs monitoring, laboratory tests, urine analysis, ECGs, and ophthalmological exams at various time points up to 30 days after treatment. Researchers also measure drug concentrations over time to assess how the combination behaves in the body. Adverse events and serious adverse events are tracked throughout to monitor safety, with follow-up continuing up to approximately 8 months after treatment.

Safety and Tolerability of Chlorquine in Addition to Anti-tuberculosis Therapy