Design of Study Sample Clauses

Design of Study. Phase I studies are exploratory and are usually performed in small groups of twenty (20) to forty (40) adults to assess the safety of the product and to detect the expected immune response [**]. Phase I studies might also be extended to the final target population [**]. The following general design is proposed at present. Each Phase I study will investigate a number of different dose levels (normally up to 4 dose levels) of Clinical Candidates [**] Schedule 1 Appendix 2 8 and involve [**] subjects per dose group. The studies will enrol male and female adult volunteer subjects [**]. Each subject will receive up to [**] doses of a single dose level. The doses will be administered at Time [**] month and [**] months after the first injection [**]. For reasons of safety, dose escalation will be [**]. Subjects will be dosed [**], such that the first [**] to be dosed will receive the lowest dose, the second [**] will receive the next highest dose with the third and fourth [**] receiving the third and fourth highest doses. Consideration of administering only [**] doses on Days [**] and [**] may also be appropriate. Alternatively, planning the study to administer [**] doses, but with a review of the [**] data after the second dose, with a view to stopping the administration of the third dose should [**] be seen after the second dose, might be worthy of consideration as this will shorten the Phase I development timelines. It is proposed that [**] dose levels will be included to establish a no effect/minimal effect dose group and to investigate if there is a dose response. Safety will be of primary importance. For this reason dose escalation will be done [**] with the lowest dose group dosed first and safety reviewed prior to the second dose group receiving their first dose. Following an appropriate safety review the third [**] will receive their first dose and if appropriately safe the final [**] will receive their first dose. Hence, the dosing of each subsequent [**] will occur approximately [**] days after dosing the preceding [**]. Subjects will receive their second dose [**] days after the first dose and their third dose [**] months after the first dose. Eligibility for administration of the second and third doses to individual volunteers will depend on the safety profile in the individual subjects following the first and second doses and will only be administered if a subject tolerates the first/second injection. Safety reviews will be conducted after each [**]...