Evaluation of the Immodin effectiveness on the immune system of healthy volunteers

Phase 1

• Conditions: Immunological efficacy, in healthy volunteers; MedDRA version: 14.1Level: LLTClassification code 10021422Term: Immune statusSystem Organ Class: 10022891 - Investigations; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2012-001709-26-CZ
• Lead Sponsor: Sevapharma,a.s.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-11
• Last Update Posted: 21 November 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified