A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MA-0211 in Healthy Adult Subjects Including a Food Effect Cohort
Completed
Astellas Pharma Global Development, Inc.
Phase 1
This first-in-human (FiH) study consists of 2 parts: single ascending dose (SAD) with
evaluation of food effect (Part 1) and multiple ascending dose (MAD) (Part 2).
The primary purpose of this study is to evaluate the safety and tolerability of single
ascending oral doses in Part 1 (SAD Including Evaluation of Food Effect) and multiple
ascending oral doses in Part 2 (MAD) of MA-0211 in healthy adult participants.
This study will also evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of single
ascending and multiple ascending oral doses of MA-0211 in healthy adult participants. In
addition, this study will evaluate the effect of a single oral dose of MA-0211 on the QT
interval using Fridericia's Correction (QTcF); determine the effect of food on the PK of a
single oral dose of MA-0211 as well as evaluate the effect of multiple oral doses of MA-0211
on the QTcF.
A Study to Assess the Safety, Tolerability and Preliminary Efficacy of ASP0367 (MA-0211) in Pediatric Male Participants With Duchenne Muscular Dystrophy (DMD)
Recruiting
Astellas Pharma Inc
Phase 1
The primary purpose of this study is to evaluate the safety and tolerability of ASP0367.
This study will also evaluate the pharmacokinetics, pharmacodynamics and efficacy on muscle
function of ASP0367.
A Study to Evaluate ASP0367 in Participants With Primary Mitochondrial Myopathy
Recruiting
Astellas Pharma Inc
Phase 2/Phase 3
The purpose of the phase 2 portion of this study is to select a biologically-active ASP0367
dose level by pharmacokinetic (PK) and pharmacodynamic (PD) evaluation. The phase 2 portion
of this study will also assess the safety and tolerability of ASP0367.
The purpose of the phase 3 portion of this study is to assess the effect of ASP0367 on
functional improvement relative to placebo and will also assess the safety and tolerability
of ASP0367 relative to placebo. The phase 3 portion of this study will also assess the effect
of ASP0367 on functional improvement and fatigue relative to placebo and will assess the
effect of ASP0367 in overall participant functioning relative to placebo.
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