Table 3.

Dosage schedule for the AdhAQP1 clinical trial

Dosage group	Vector (genomes/gland)	Vector (genomes/μl)
1	4.8 × 107	1 × 105
2	2.9 × 108	5.8 × 105
3	1.3 × 109	2.6 × 106
4	5.8 × 109	1.2 × 107
5	3.5 × 1010	0.7 × 108

This table shows the number of AdhAQP1 vector genomes to be administered to a single parotid gland in subjects (n = 3) in each of the five dosage groups approved for clinical study. The administered doses are presented as both the total dose to be administered (middle column) and the number of vector genomes to be administered per μl infusate, i.e., assuming an infusate volume of 500μl (right column). Note that an additional three subjects can be enrolled if 1 of 3 subjects in a given dosage group experiences a dose-limiting toxicity. Also, if there are no adverse events in the three assigned subjects in the highest dosage group, an additional three subjects can be studied at that dose. Thus, a maximum of 21 patients can be studied under the approved clinical protocol. See website given in footnote 2 for additional information about this protocol