Pharmacodynamics of the Nasalferon in healthy volunteers.

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General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Pharmacodynamics and safety of recombinant interferon alfa 2b, by different routes of administration, in healthy volunteers.

Secondary indentifying numbers:

IG/IAGN/VS/2001

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB)

Source(s) of monetary or material support:

Center for Genetic Engineering and Biotechnology (CIGB), Havana. Ministry of Public Health, Cuba.

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Carlos

Midle name:

Alberto

Last name:

Gonzalez Delgado

Medical Specialty :

2nd degree specialist in Clinical Pharmacology

Affiliation:

National Toxicology Center (CENATOX)

Postal address:

Calle 114 y Ave. 31, Marianao

City:

Havana

Country:

Cuba

Zip Code:

11500

Telephone:

+53-72601230

Email address:

carglez@infomed.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

04/05/2020

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Pharmacodynamics and safety in healthy volunteers

Intervention(s):

Group I: Recombinant human interferon (IFN) alpha-2b, 1 drop (0.05 mL) in each nostril (0.5 MIU IFN alpha 2b), every 12 hours (2.0 MIU daily) for 5 consecutive days. Group II: Recombinant human interferon (IFN) alpha-2b, 3 drops (0.15 mL) sublingually (1.5 MIU IFN alpha 2b), every 12 hours (3.0 MIU daily) for 5 consecutive days. Group III: Recombinant human interferon (IFN) alpha-2b, 1 drop (0.05 mL) in each nostril (0.5 MIU IFN alpha 2b), every 6 hours (4.0 MIU daily) for 5 consecutive days. Group IV: Recombinant human interferon (IFN) alpha-2b, 5 drops (0.25 mL) sublingually (2.5 MIU IFN alpha 2b), every 12 hours (5.0 MIU daily) for 5 consecutive days. Group V: Recombinant human interferon (IFN) alpha-2b, 2 drops (0.1 mL) in each nostril (1.0 MIU IFN alpha 2b), every 8 hours (6.0 MIU daily) for 5 consecutive days. Group VI: Recombinant human interferon (IFN) alpha-2b, 12 drops (0.6 mL) diluted in 2 mL of water for injection, aerosolized (6.0 MIU IFN alpha 2b), every 12 hours (12.0 MIU daily) for 5 consecutive days.

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Levels of local and systemic expression of markers of activity of the cellular signaling system stimulated by IFN alpha (2-5 oligo adenylate synthetase for antiviral activity and β2-microglobulin for activity of the immune system), evaluated by PCR on tissue obtained from nasal scraping and sublingual (for evaluations at the local level) and in peripheral blood (for evaluations at the systemic level). Measurement time: At baseline, 72 hours after the first administration of IFN alfa and, 24 hours after the last administration.

Key secondary outcomes:

1) Levels of local and systematic expression of other pharmacodynamic markers (STAT-1 and STAT-3 as markers of stimulation of IFNs signaling and expression of Toll-like receptors 3 and 7 as markers of activation of the immune system) nasal scraping and sublingual. Measurement time: At baseline, 72 hours after the first administration of IFN alfa and, 24 hours after the last administration. 2) Levels of blood expression of NK cells, lymphocytes, activation of macrophages and HLD-DR (by flow cytometry). Measurement time: At baseline and, 24 hours after the last administration. 3) Clinical Adverse Events-A (They will be measured as: -AE occurrence (Yes, No), -AE description (name of the event), -AE intensity (mild, moderate, severe), -Causal relationship (unrelated, doubtful, possible, probable, Definitive), -Measures taken (None, Administration of any pharmacological therapy, Addition of a non-pharmacological therapy, Exit of the study, Hospitalization / prolongation of hospitalization), -Result (Fully resolved, Resolved with sequelae, Conditions in improvement, Present condition and unchanged, worsening, death caused by this event)). Measurement time: daily throughout five days.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male

Minimum age:

19 years

Maximum age:

60 years

Inclusion criteria:

1) Apparently healthy male individuals. 2) Between 19 and 60 years old, both inclusive. 3) Absence of clinically relevant manifestations in the interrogation and physical examination. 4) Normal electrocardiogram. 5) Analysis of hematology, blood chemistry and urine within normal limits. 6) Normal body weight for height. 7) Voluntary nature of the subject by signing the informed consent.

Exclusion criteria:

1) Treatment with immunosuppressants in the last month prior to inclusion. 2) Ongoing systemic treatment, for any cause, with IFN alpha. 3) Malignant neoplasm (except basal skin carcinoma). 4) Acute respiratory disease of the respiratory tract in the preceding week or at the time of evaluation for inclusion. 5) Use of any other intranasal medication 6) Allergic rhinitis present or history of recurrent episodes. 7) Nasal bleeding present or history of recurrent episodes. 8) Chronic asthma. 9) Autoimmune disease. 10) History of endocrine-metabolic disorders. 11) History of significant acute diseases in the last 30 days. 12) History of chronic diseases (cardiovascular, respiratory, neurological, renal, gastrointestinal, hepatic or hematological). 13) Administration of an investigational drug in the 45 days prior to inclusion in the study. 14) Use of any medication during the 15 days before entering the study. 15) History of serious adverse reactions or hypersensitivity to any drug. 16) History of alcoholism or alcohol consumption within 24 hours prior to administration of the study drug. 17) Known hypersensitivity to any of the components of the formulation under study. 18) Obvious mental incapacity to issue consent and act accordingly with the study.

Type of population:

Adults

Type of participant:

Healthy volunteers

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Other

Other purpose:

Pharmacodynamics / Security

Allocation:

Randomized trial

Masking:

Open

Control group:

Uncontrolled

Study design:

Parallel

Phase:

1

Target sample size:

30

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Hugo

Last Name:

Nodarse Cuni

Specialty:

Doctor of Pharmaceutical Sciences

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave. 31 entre 158 y 190, Cubanacan, Playa.

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+53-72085887, 72087465

Email :

hugo.nodarse@cigb.edu.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Hugo

Last Name:

Nodarse Cuni

Specialty:

Doctor of Pharmaceutical Sciences

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave. 31 entre 158 y 190, Cubanacan, Playa.

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+53-72085887, 72087465

Email :

hugo.nodarse@cigb.edu.cu

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

National Toxicology Center (CENATOX)

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

27/04/2020

Postal address of Ethic Committee :

Calle 114 y Ave. 31, Marianao, La Habana, C.P:11500, Cuba

Telephone:

53-72601230

Email:

carglez@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

09/06/2020

Date of available results:

31/08/2020

Date of first publication:

30/09/2020

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000308

Date of Registration in Primary Registry:

03/05/2020

Record Verification Date:

2020/05/03

Next update date:

2021/05/03

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Pharmacodynamics of the Nasalferon in healthy volunteers.

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