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A Study to Evaluate the Safety, Tolerability, and Efficacy of Subcutaneous Injections of Elamipretide (MTP-131) in Subjects With Genetically Confirmed Mitochondrial Disease Previously Treated in the Stealth BioTherapeutics SPIMM-201 Study
This is a Phase 2, randomized, double-blind, placebo-controlled crossover study which will enroll up to 36 subjects (anticipated) with genetically confirmed mitochondrial disease who have completed participation in the SPIMM-201 (MMPOWER) study. Subjects will be randomized (1:1) to one of two sequence groups: 4-weeks of treatment with 40 mg elamipretide administered once da...
Haemophilus influenza type b (Hib) remains a serious global health threat associated with high mortality and morbidity in young children. In China, The overall impact of Hib-related infections and the extent of coverage of Hib conjugate vaccines are unclear.Generally, vaccination has been considered the most effective way to prevent infection against Hib.In order to evaluat...
The aim of this study is to evaluate the speed and quality with which OASIS® Ultra (Healthpoint Biotherapeutics; Fort Worth, Texas) increases wound healing in the critical sized defect. The investigators intend on confirming the histological composition of the dermal substitute in order to delineate the amount of cellular recruitment, collagen deposition and neovasculari...
The purpose of this study is to: - evaluate the safety profile of a single intravenous administration of AIGIV (containing either 3.5 mg/kg, 7.0 mg/kg or 14.0 mg/kg anti-PA IgG) as compared with either 90 mg/kg, 180 mg/kg or 360 mg/kg total IgG, GAMUNEX(R)(immune globulin intravenous (human) 10% caprylate/chromatography purified). GAMUNEX is a trademark o...
This is a molecular imaging research study designed to examine how much nicotine gets into the brain before and after vaccination with NicVAX, a nicotine vaccine developed by Nabi Biopharmaceuticals. NicVAX (Nicotine Conjugate Vaccine) is an investigational vaccine designed as an aid to smoking cessation and long-term abstinence, as well as an aid to prevent relapses of a t...