Safety, Tolerability, Pharmacokinetics and Efficacy of SPR720 for the Treatment of Patients With Mycobacterium Avium Complex (MAC) Pulmonary Disease

PHASE2TerminatedINTERVENTIONAL
Enrollment

2

Participants

Timeline

Start Date

December 3, 2020

Primary Completion Date

January 28, 2021

Study Completion Date

January 28, 2021

Conditions
Mycobacterium Avium ComplexNon-tuberculous Mycobacterium Pulmonary Disease
Interventions
DRUG

SPR720

Capsules for oral administration

DRUG

Placebo

Capsules for oral administration

DRUG

Open-label Standard of Care

"Standard of Care regimen is at the Investigator's discretion; recommended 2-drug or 3-drug SOC, consisting of either:~* Clarithromycin 500-1000 mg, plus ethambutol hydrochloride (HCl) 15 mg/kg orally once daily or~* Azithromycin 250-500 mg plus ethambutol HCl 15 mg/kg orally once daily.~Optional rifampin 600 mg or rifabutin 300 mg orally once daily may be added to the SOC regimen for up to 28 days."

Trial Locations (9)

15213

Medical Facility, Pittsburgh

27103

Medical Facility, Winston-Salem

28117

Medical Facility, Mooresville

28207

Medical Facility, Charlotte

32701

Medical Facility, Altamonte Springs

33407

Medical Facility, West Palm Beach

33462

Medical Facility, Atlantis

33765

Medical Facility, Clearwater

34746

Medical Facility, Kissimmee

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Spero Therapeutics

INDUSTRY

NCT04553406 - Safety, Tolerability, Pharmacokinetics and Efficacy of SPR720 for the Treatment of Patients With Mycobacterium Avium Complex (MAC) Pulmonary Disease | Biotech Hunter | Biotech Hunter