Immunological efficacy, in healthy volunteers MedDRA version: 14.1 Level: LLT Classification code 10021422 Term: Immune status System Organ Class: 10022891 - Investigations
Conditions
Interventions
Trade Name: Immodin
Product Name: Immodin
Pharmaceutical Form: Lyophilisate and solvent for solution for injection
Product Name: water for injection
Pharmaceutical Form: Solution for injection
Pharma
Sponsors
Sevapharma,a.s.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must have signed an approved informed consent after full information Subjects meet the conditions of healthy individuals or eventual blood donors. Subjects in good health with no acute illness last 4 weeks. Men and women aged 18 to 30 years. Subjects meet the conditions of cellular immunity within the normal range. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subject with acute infectious diseases. Subject with immunodeficiency, including allergic diseases (anamnestically). Pregnant woman and breastfeeding (anamnestically). Woman at fertile age without adequate contraception (barrier and hormonal) or without practicing sexual abstinence. Subject allergic to any of the substances of the investigational medicinal product administered in clinical trial. Inability of cooperation or irresponsibility. Current participation in another clinical trial or in drug evaluation, within 4 weeks prior to study entry. Known or suspected history of alcoholism or drug abuse. Unwillingness to sign informed consent. Dependents (eg conscripts, persons dependent on the researcher - such as subordinates, family members).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the immunological efficacy during and after Immodin application related to control group, in healthy volunteers;Secondary Objective: Dynamics of immunological primary endpoint Evaluation of Immodin tolerance in healthy volunteers;Primary end point(s): Immunological effectiveness, parameters of cellular immunity;Timepoint(s) of evaluation of this end point: Follow-up of IMP administration (1-7 days after the first administration) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Evolution of cellular immunity, Safety parameters (biochemistry, urinalysis, haematology, vital functions, adverse events);Timepoint(s) of evaluation of this end point: Follow-up of IMP administration (1-7 days after the first administration) | — |
Countries
Czech Republic
Contacts
Public ContactJudita Vadass
Sevapharma, a.s.
Outcome results
None listed