NCT00372320 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Baum BJ, Voutetakis A, Wang J
Salivary glands: novel target sites for gene therapeutics. Trends Mol Med. 2004 Dec;10(12):585-90. Review.
Baum BJ, Wellner RB, Zheng C
Gene transfer to salivary glands. Int Rev Cytol. 2002;213:93-146. Review.
Zufferey R, Aebischer P
Salivary glands and gene therapy: the mouth waters. Gene Ther. 2004 Oct;11(19):1425-6.

Open-Label, Dose-Escalation Study Evaluating the Safety of a Single Administration of AdhAQP1, an Adenoviral Vector Encoding Human Aquaporin-1 to One Parotid Salivary Gland in Individuals With Irradiation-Induced Parotid Salivary Hypofunction

Details for clinical trial NCT00372320

Clinical trial NCT00372320 - References