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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Helicobacter Pylori Infected Subjects
- Sponsor
- ImevaX
- Enrollment
- 72
- Locations
- 2
- Primary Endpoint
- Safety and tolerability of IMX101
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •H. pylori-infected subjects: Confirmed H. pylori infection by urea breath test and serology.
- •H. pylori-negative subjects: Presenting no H. pylori infection by urea breath test and serology.
- •Men and women aged ≥18 years and ≤ 50 years.
- •Female subjects must either be of non-childbearing potential or use highly effective methods of contraception for at least 1 month prior to Screening and 1 month after end of study participation (see section pregnancy and contraceptives).
- •Women with a negative serum test at Screening (V2) and women of childbearing potential additionally with a negative urine pregnancy test at each visit (except V1 and FU V10/V12).
- •Have given written informed consent prior to admission to the study in accordance with ICH-GCP and local legislation.
- •Ability to comply with the requirements of the study protocol.
Exclusion Criteria
- •History of successful treatment for H. pylori infection.
- •Regular use (once a week or more) of diclofenac, other non-steroidal anti-inflammatory drugs (NSAIDs), e.g. acetylsalicylic acid (Aspirin®), or proton pump inhibitor (PPI). Additionally, PPI is used within 2 weeks prior to V1 and V
- •Use of anticoagulants (i.e. heparin, coumarin derivatives, e.g. Marcumar®).
- •Use of antibiotics employed in H. pylori therapy within the month prior to study entry (V1) as well as 1 month prior to each endoscopy (V3 and V9/V11).
- •Recent or current (within the last 6 months) systemic corticosteroid use including inhaled corticosteroids. Topical corticosteroid medication is allowed.
- •Current or previous gastric ulcer diseases or preneoplastic changes in the stomach mucosa according to medical records or endoscopy findings confirmed by histological assessment at Baseline (V3).
- •Current or previous medically significant gastroduodenal disease.
- •Preceding cholera immunisation or disease.
- •Uncontrolled hypertension or orthostatic hypotension.
- •Body mass index (BMI) ≤ 18 or ≥
Outcomes
Primary Outcomes
Safety and tolerability of IMX101
Time Frame: 215 days
All subjects who received at least one dose of the IMP will be included in the safety analysis by following parameters: -Adverse events: AEs will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA). Separate analyses will be conducted using severity, seriousness, and relationship to the IMP. Treatment-emergent adverse events (TEAEs) will be summarised and tabulated according to the primary system organ class and preferred term. * Clinical laboratory and other safety measures Haematology and clinical chemistry will be summarised with descriptive statistics for absolute values und changes from Baseline by visit. Urine dipstick test will be summarised with frequency tables by visit. * Vital signs Vital signs will be summarised with descriptive statistics for absolute values und changes from Baseline by visit. * Local tolerability Injection site assessments will be summarised in frequency tables when the collected data allow for this.
Secondary Outcomes
- Determination of immune Responses(215 days)