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Phase 1a/b Study on Safety of IMX101 in H. Pylori-negative and H. Pylori-infected Healthy Volunteers

2017-09-04 22:02:16 | BioPortfolio

Summary

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.

Study Design

Conditions

Helicobacter-Associated Disease

Intervention

CTA control, IMX101 vaccine

Location

ClinicalTrial Site
Hamburg
Germany

Status

Recruiting

Source

ImevaX

Results (where available)

View Results

Links

Published on BioPortfolio: 2017-09-04T22:02:16-0400

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Infections with organisms of the genus HELICOBACTER, particularly, in humans, HELICOBACTER PYLORI. The clinical manifestations are focused in the stomach, usually the gastric mucosa and antrum, and the upper duodenum. This infection plays a major role in the pathogenesis of type B gastritis and peptic ulcer disease.

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