A Randomized, Double-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

Date Added
March 28th, 2023
PRO Number
Patrick Flume

List of Studies

Nontuberculous mycobacteria (NTM)

This is a Phase 2, multicenter, randomized, double blinded, placebo-controlled study to evaluate the efficacy, safety, tolerability, and PK of two dose levels of SPR720 compared with placebo for the treatment of patients with NTM-PD due to MAC. 31 patients 18 years and older with a diagnosis of NTM-PD due to MAC will be enrolled and treated for 56 days (about 27 treatment naive, treatment inexperienced patients with NTM-PD will be randomized in a 1:1:1 ratio to receive placebo, SPR720 500 mg, or SPR720 1000 mg in a blinded manner.
Sparse PK Group (Treatment Arms 1-3): For all remaining patients, Sparse PK blood samples will be collected pre-dose (no greater than 1 h prior to dosing) on Days 7, 14 and 28; and post- dose on Day 14 (at 1 h, and 3 h), and just before discharge from the clinic (at least 6 h post- dose).

Recruitment Contact
Zerlinna Teague