drugset / Trial / NCT05496374

A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SPR720 as Compared With Placebo for the Treatment of Participants With Mycobacterium Avium Complex (MAC) Pulmonary Disease

NCT05496374

Phase 2 Completed 25 enrolled Spero Therapeutics
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of the study is to evaluate 1. The microbiological response and clinical efficacy of SPR720 compared with placebo in participants with nontuberculous mycobacteria pulmonary disease (NTM-PD). 2. The safety and tolerability of SPR720 in participants with NTM- PD 3. The pharmacokinetic (PK) of SPR719, active moiety, following orally (po) administered prodrug SPR720 in participants with NTM-PD.

Timeline

Start
2022-12-14
Primary completion
2024-10-08
Completion
2024-12-02

Drugs

EvaluationDrugModalityDoseRoute
Subject SPR720 Small molecule 500 mg Oral
Subject SPR720 Small molecule 1000 mg Oral