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Home » NASTECH INITIATES PHASE I TRIAL FOR INTRANASAL PARATHYROID
NASTECH INITIATES PHASE I TRIAL FOR INTRANASAL PARATHYROID
July 5, 2005
Nastech Pharmaceutical has commenced a Phase I pharmacokinetic study with its intranasal Parathyroid Hormone (PTH1-34) to treat osteoporosis.
The study will be conducted using the Nastech's advanced intranasal formulation that utilizes its Tight Junction drug delivery technology to enable needle-free delivery of therapeutic levels of drugs, such as peptides and proteins, which would otherwise require an injection.
The objective of the study will be to determine the nasal absorption and safety of the PTH1-34 nasal spray versus the approved subcutaneous product. The study is the first of several to select the commercial formulation and determine the appropriate dose to be used in the future PTH1-34 nasal spray clinical studies required for approval. The pivotal clinical trial, on which an FDA submission will be based, will be a six-month non-inferiority study comparing PTH1-34 nasal spray with the approved subcutaneous product measuring bone mineral density levels as the endpoint.
KEYWORDS Drug Pipeline Alert
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