Helicobacter Pylori Infected Subjects Clinical Trial
Official title:
A Randomized, Double-blind, Adjuvant-controlled Phase 1a/b Study on Safety and Tolerability With Ascending Multiple Doses of IMX101 in H. Pylori-negative and H. Pylori-infected Healthy Volunteers
A Phase 1, multi-center, randomised, double-blind and adjuvant-controlled study to evaluate
the safety, tolerability, and efficacy of IMX101 in H. pylori-negative and H. pylori-infected
healthy volunteers.
The study will be conducted in 2 phases. Phase A: Study design contains 6 cohorts, each
containing 8 subjects. Three cohorts (24 subjects) will be H. pylori-negative and 3 cohorts
will be H. pylori-infected. Subjects fulfilling the inclusion criteria will be assigned to
one of 3 sequential dose cohorts with a 3:1 randomisation to IMX101 or to CTA within each
cohort.
Phase B: Two cohorts with H. pylori-infected subjects can be expanded up to 20 subjects in
each cohort. The decision whether to expand the cohorts will be taken by the Sponsor and the
DSMB, as soon as the results of the safety and efficacy analyses are available.
Up to 72 subjects collectively in Phases A & B will be recruited. depending on immunogenicity
status.
n/a