drugset
drugset / Trial / NCT01115920

Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of Intravenous (IV) Infusion of MTP-131 (Bendavia™) in Healthy Adults

NCT01115920 ↗

Phase 1 Completed 40 enrolled Stealth BioTherapeutics Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is the first study of MTP-131 (Bendavia™) in humans. The objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of escalating single intravenous infusion doses of MTP-131.

Timeline

Start
2010-05
Primary completion
2010-09
Completion
2010-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Elamipretide Peptide 0.01 mg/kg Intravenous
Subject Elamipretide Peptide 0.025 mg/kg Intravenous
Subject Elamipretide Peptide 0.05 mg/kg Intravenous
Subject Elamipretide Peptide 0.1 mg/kg Intravenous
Subject Elamipretide Peptide 0.25 mg/kg Intravenous

Indications

No indication recorded.