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

NCT03270800 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2019-02-15

No results posted yet for this study

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.

Conditions

  • Helicobacter Pylori Infected Subjects
  • Helicobacter Pylori Naive Subjects

Interventions

BIOLOGICAL

CTA control

Sublingual and intradernal application of a mucosal adjuvance, drug product is not yet on the market.

BIOLOGICAL

IMX101 vaccine

Sublingual and intradermal application of a vaccine, drug product is not yet on the market.

Sponsors & Collaborators

  • ImevaX

    lead INDUSTRY

Principal Investigators

  • Sandra Zivotic · CTC-NORTH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-30
Primary Completion
2018-12-23
Completion
2018-12-23

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03270800 on ClinicalTrials.gov