Abstract

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. When administered by oral inhalation using a dry powder inhaler DAS181 is intended to treat naturally acquired influenza. . This is a randomized, double-blinded, dose escalating Phase 1 study of a single dose treatment with DAS181 in healthy adults. Subjects will be randomized in a 2:1 ratio to receive either a single dose treatment with DAS181 or placebo. The study is designed to explore the safety and tolerability of a single dose treatment with DAS181, based on a combination of the adverse event rates, immunogenicity profile and pharmacokinetic profile. The data from this study will be used to select the dose levels for future studies. The study will be conducted in dose escalating steps, which will start from the lowest dose level and move to the higher dose levels after dose escalating criteria are met. Within each dose group, study drug dosing will be initiated in staggered steps. The subjects will be followed for 30 days after dosing.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000847-36
Application #
7951500
Study Section
Special Emphasis Panel (ZRR1-CR-8 (01))
Project Start
2009-03-01
Project End
2010-02-28
Budget Start
2009-03-01
Budget End
2010-02-28
Support Year
36
Fiscal Year
2009
Total Cost
$69,219
Indirect Cost

  Institution

Name
University of Virginia
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
065391526
City
Charlottesville
State
VA
Country
United States
Zip Code
22904

  Publications

Campbell, Garland A; Patrie, James T; Gaylinn, Bruce D et al. (2018) Oral ghrelin receptor agonist MK-0677 increases serum insulin-like growth factor 1 in hemodialysis patients: a randomized blinded study. Nephrol Dial Transplant 33:523-530
Malin, Steven K; Rynders, Corey A; Weltman, Judy Y et al. (2016) Endothelial function following glucose ingestion in adults with prediabetes: Role of exercise intensity. Obesity (Silver Spring) 24:1515-21
Rynders, Corey A; Weltman, Judy Y; Malin, Steven K et al. (2016) Comparing Simple Insulin Sensitivity Indices to the Oral Minimal Model Postexercise. Med Sci Sports Exerc 48:66-72
Hu, Yinin; Kim, Helen; Blackwell, Christopher M et al. (2015) Long-term outcomes of helper peptide vaccination for metastatic melanoma. Ann Surg 262:456-64; discussion 462-4
Marozkina, Nadzeya V; Wang, Xin-Qun; Stsiapura, Vitali et al. (2015) Phenotype of asthmatics with increased airway S-nitrosoglutathione reductase activity. Eur Respir J 45:87-97
Nass, Ralf; Nikolayev, Alexander; Liu, Jianhua et al. (2015) The level of circulating octanoate does not predict ghrelin O-acyl transferase (GOAT)-mediated acylation of ghrelin during fasting. J Clin Endocrinol Metab 100:E110-3
Argo, Curtis K; Patrie, James T; Lackner, Carolin et al. (2015) Effects of n-3 fish oil on metabolic and histological parameters in NASH: a double-blind, randomized, placebo-controlled trial. J Hepatol 62:190-7
Chyun, Deborah A; Wackers, Frans J Th; Inzucchi, Silvio E et al. (2015) Autonomic dysfunction independently predicts poor cardiovascular outcomes in asymptomatic individuals with type 2 diabetes in the DIAD study. SAGE Open Med 3:2050312114568476
Hu, Yinin; Petroni, Gina R; Olson, Walter C et al. (2014) Immunologic hierarchy, class II MHC promiscuity, and epitope spreading of a melanoma helper peptide vaccine. Cancer Immunol Immunother 63:779-86
Paige, Mikell; Wang, Kan; Burdick, Marie et al. (2014) Role of leukotriene A4 hydrolase aminopeptidase in the pathogenesis of emphysema. J Immunol 192:5059-68

Showing the most recent 10 out of 674 publications