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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 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-10-09

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Spero Therapeutics

    lead INDUSTRY

Principal Investigators

  • Xilla Ussrey, MD · Spero Therapeutics Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-14
Primary Completion
2024-10-08
Completion
2024-12-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT05496374 on ClinicalTrials.gov