Pharmacodynamics and safety in healthy volunteers pharmacodynamics
Conditions
Interventions
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 interf
Interferon-alpha
Administration, Intranasal
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB), in Havana
Eligibility
Sex/Gender
Male
Age
19 Years to 60 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 ß2-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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Cuba
Contacts
Public ContactHugo Nodarse Cuni
Center for Genetic Engineering and Biotechnology (CIGB).
Outcome results
None listed