Clinical Trials Register

Summary
EudraCT Number:	2012-001709-26
Sponsor's Protocol Code Number:	IMS012012
National Competent Authority:	Czechia - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-05-11
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Czechia - SUKL

A.2

EudraCT number

2012-001709-26

A.3

Full title of the trial

Randomized, double-blind, placebo-controlled clinical trial of Immodin immunological efficacy in healthy adult volunteers.

Randomizované, dvojitě zaslepené, placebem kontrolované klinické hodnocení imunologické účinnosti přípravku Immodin u zdravých dospělých dobrovolníků.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

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

Hodnocení účinnosti Immodinu na imunitním systému zdravých dobrovolníků

A.3.2

Name or abbreviated title of the trial where available

not available

není k dispozici

A.4.1

Sponsor's protocol code number

IMS012012

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Sevapharma,a.s.
B.1.3.4	Country	Czech Republic
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Sevapharma, a.s.
B.4.2	Country	Czech Republic
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Sevapharma, a.s.
B.5.2	Functional name of contact point	Judita Vadass
B.5.3	Address:
B.5.3.1	Street Address	Vltavská 53
B.5.3.2	Town/ city	Roztoky
B.5.3.3	Post code	252 63
B.5.4	Telephone number	+420271 733 504
B.5.5	Fax number	+420233 012 805
B.5.6	E-mail	sekretariat@sevapharma.cz

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Immodin
D.2.1.1.2	Name of the Marketing Authorisation holder	Sevapharma, a.s.
D.2.1.2	Country which granted the Marketing Authorisation	Slovakia
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Immodin
D.3.4	Pharmaceutical form	Lyophilisate and solvent for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.1.2	Country which granted the Marketing Authorisation	Czech Republic
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	water for injection
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	solvent for Immodin

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection
D.8.4	Route of administration of the placebo	Subcutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Immunological efficacy, in healthy volunteers

Imunologická účinnost, u zdravých dobrovolníků

E.1.1.1

Medical condition in easily understood language

Immodin effectiveness on the immune system of healthy volunteers

Účinnost Immunodinu na imunitním systému zdravých jedinců

E.1.1.2

Therapeutic area

Body processes [G] - Immune system processes [G12]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10021422
E.1.2	Term	Immune status
E.1.2	System Organ Class	10022891 - Investigations

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Evaluation of the immunological efficacy during and after Immodin application related to control group, in healthy volunteers

Zhodnocení imunologické účinnosti během a po aplikaci Immodinu vzhledem ke kontrolní skupině, u zdravých dobrovolníků

E.2.2

Secondary objectives of the trial

Dynamics of immunological primary endpoint
Evaluation of Immodin tolerance in healthy volunteers

Dynamika vývoje primární veličiny imunologické účinnosti
Zhodnocení bezpečnosti Immodinu u zdravých dobrovolníků

E.2.3

Trial contains a sub-study

E.3

Principal 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.

Informovaný souhlas dobrovolně podepsaný po úplné informaci subjektu.
Subjekt splňující podmínky zdravého jedince, případně dárce krve.
Subjekt v dobrém zdravotním stavu bez akutního onemocnění poslední 4 týdny.
Muži i ženy ve věku 18 - 30 let.
Subjekt splňující podmínky buněčné imunity v mezích normálních hodnot.

E.4

Principal 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).

Subjekt s akutním infekčním onemocněním.
Subjekt s imunodeficiencí, včetně alergického onemocnění (anamnesticky).
Gravidní žena a žena v laktaci (anamnesticky).
Žena ve fertilním věku bez adekvátní antikoncepce (bariérové, hormonální) nebo bez praktikování pohlavní abstinence.
Subjekt alergický na některou z látek v hodnoceném přípravku, podávaného v rámci klinického hodnocení.
Neschopnost spolupráce, nesvéprávnost.
Současná účast v jiném klinickém hodnocení léčiva či v hodnocení, které se konalo v uplynulých 4 týdnech.
Závislost na alkoholu, drogách.
Neochota podepsat informovaný souhlas.
Závislé osoby (např. vojáci v základní službě, osoby závislé na výzkumníkovi – např. podřízení, rodinní příslušníci).

E.5 End points

E.5.1

Primary end point(s)

Immunological effectiveness, parameters of cellular immunity

Imunologická účinnost, parametry buněčné imunity

E.5.1.1

Timepoint(s) of evaluation of this end point

Follow-up of IMP administration (1-7 days after the first administration)

Sledování po aplikaci klinicky hodnoceného léčiva (1-7 dní po první aplikaci)

E.5.2

Secondary end point(s)

Evolution of cellular immunity, Safety parameters (biochemistry, urinalysis, haematology, vital functions, adverse events)

Vývoj buněčné imunity, bezpečnostní parametry (biochemie, rozbor moči, krevní obraz, vitální funkce a nežádoucí příhody)

E.5.2.1

Timepoint(s) of evaluation of this end point

Follow-up of IMP administration (1-7 days after the first administration)

Sledování po aplikaci klinicky hodnoceného léčiva (1-7 dní po první aplikaci)

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

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

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

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

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
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.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	Yes
F.3.2	Patients	No
F.3.3	Specific vulnerable populations	No
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	No
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	60

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2012-06-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-06-28

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2012-09-13

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