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

A Randomized, Investigator-Blinded, Placebo-Controlled, Multicenter, Phase 2, Dose-Ranging Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SPR720 as Compared With Placebo for the Treatment of Patients With Mycobacterium Avium Complex (MAC) Pulmonary Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Spero Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nontuberculous Mycobacterial Pulmonary Disease (NTM-PD)

Interventions

Type	Name	Description
DRUG	Placebo	Placebo-matching capsules was administered orally.
DRUG	SPR720 500 mg	SPR720 500 mg (250 mg × 2 capsules) was administered orally.
DRUG	SPR720 1000 mg	SPR720 500 mg (250 mg × 4 capsules) was administered orally.

Timeline

• Start date: 2022-12-14
• Primary completion: 2024-10-08
• Completion: 2024-12-02
• First posted: 2022-08-11
• Last updated: 2025-10-09

Locations

28 sites across 1 country: United States

Regulatory

• FDA-regulated drug study