E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Safety of immunization with KLH following oral and / or parenteral administration |
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E.2.2 | Secondary objectives of the trial |
Occurrence of a cutaneous immune response of type IV (delayed type, delayed type hypersensitivity "DTH") after immunization Detectable KLH-specific T- and B-cell responses |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Written consent (according to § 40 AMG (1) 3 b) • Age 18 - 69 years • • negative pregnancy test • • highly effective contraception in women (defined as the Pearl Index <1) • No participation in another study by the AMG one month before and during participation, and after 5 half-lives of / investigational product / s from the previous AMG study • During the study, taking a normal diet For the group A5 is also the inclusion criterion • Indication for elective resection for diverticulitis |
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E.4 | Principal exclusion criteria |
• Pregnancy and lactation • contraindications to study medication (including excipients of the pharmaceutical form) • immunodeficiency • Hypersensitivity to exogenous protein • Interactions with the study medication (KLH) • Use of gastric acid-inhibiting agents (H2 blockers, proton pump inhibitors (PPIs) • Immunosuppressive or anti-inflammatory medication • vaccination three months before or during participation • lack of willingness to store and transfer data pseudonymous disease in the clinical examination • Accommodation in an institution of judicial or administrative order • chronic infections (eg chronic hepatitis, tuberculosis) • Chronic diseases (eg severe asthma, chronic obstructive pulmonary disease, autoimmune diseases) • serious illness of important organs (liver, kidney, GFR calculated <60 ml / min, lung, heart. Clinical signs of heart failure> NYHA I, left ventricular ejection fraction <45%, absolute arrhythmia with atrial fibrillation with the need for medical anticoagulation, non-drug controlled heart rhythm disorder), hemodynamically relevant pericardial effusion-) • fatal cerebrovascular events currently or in the case history (eg, TIA, PRIND) and other CNS disorders such as multiple sclerosis, myasthenia gravis • Diabetes mellitus • tumors • psychiatric illness • Drugs or drug abuse • severe allergic reaction in the past. • Pathological laboratory abnormalities for: serum ALT and GGT, creatinine and blood |
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E.5 End points |
E.5.1 | Primary end point(s) |
Frequency of adverse events after oral and/or parenteral KLH administration |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Adverse events will be assessed at the study visits |
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E.5.2 | Secondary end point(s) |
Occurence of a cutaneous DTH reaction KLH-specific T- and B-cell responses |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
DTH reactions will be assessed 24h and 48h after parenteral immunization KLH-specific T- and B-cell responses will be examined at the study visits |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The trial ends at the last visit of the last subject undergoing the trial |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |