SOFIA Study

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000118
• Date of registration: 24/05/2011
• Primary sponsor: Center for Genetic Engineering and Biotechnology (CIGB), in Havana.
• Public title: SOFIA Study
• Scientific title: Pharmacodynamics and pharmacokinetics of two formulations containing a synergic mixture of interferons in healthy volunteers.
• Date of first enrolment: 15/07/2011
• Target sample size: 16
• Recruitment status: Pending
• URL: http://registroclinico.sld.cu/trials/RPCEC00000118-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Double Blind Placebo: Active Assignment: Cross-over Purpose: Other

Countries of recruitment

Cuba

Contacts

• Name: MSc. Idrian García García
• Affiliation: Center for Genetic Engineering and Biotechnology (CIGB).

• Name: Dr. Iraldo Bello Rivero
• Affiliation: Center for Genetic Engineering and Biotechnology (CIGB).

Key inclusion & exclusion criteria

Inclusion criteria: 1) Body mass index between 19 and 29 Kg/m2. 2) Hematological parameters (hemogram, globular sedimentation rate, coagulogram) within normal limits. 3) Biochemical parameters (glucose, cholesterol, creatinine, urea, uric acid, alkaline phospatase, transaminases, bilirubin, others) within normal limits. 4) Urine analysis (density, pH, glucose, bilis, leukocytes, erythrocytes) within normal limits. 5) No reactive serology and negative to HIV, hepatitis B and C virus infections markers in serum. 6) No consumption of drugs in the previous 15 days. 7) No symptoms or signs of any disease at the physical examination. 8) Written, informed consent to participate.
Exclusion criteria: 1) No fulfillment of any inclusion criteria. 2) History of chronic diseases. 3) Suffer any acute illness in the previous 30 days. 4) Smoking habit. 5) History of allergic reactions or hypersensibility to drugs (including antipyretics and interferons) and any ingredient of both studied formulations (considering investigator criteria) 6) Alcoholism (more than a quarter of rum bottle, one wine bottle or three beers, more than two times per week), or addiction to drugs in the previous year. 7) Surgical interventions in the previous 6 months. 8) Blood donation in the previous 2 months. 9) Treatment with any type of interferon at any moment previous inclusion. 10) To have been included in another clinical trial with therapeutic intervention in the previous year before inclusion.

Age minimum: 18 years
Age maximum: 35 years
Gender: Male

Health Condition(s) or Problem(s) studied

Pharmacodynamics and pharmacokinetics of interferon formulations in healthy volunteers.

Intervention(s)

A phase I, randomized, crossover (two period), double-blind study with a three-weeks washout period as minimum will be carried out in healthy volunteers. Formulation A (Control): Interferon alpha 2b and interferon gamma (HeberPAG) Formulation B: interferon alpha 2b and interferon gamma (New Formulation) - A single 24.5 x 106 IU will be administered intramuscularly in both groups. - The study will last 192 hours (9 days) in each treatment period. - During each period, individuals were hospitalized during the first 48 hours after the injection under strict medical supervision. - Blood sampling and adverse reactions monitoring will be continued ambulatorily until 192 hours. - Antipyretic medication will be given orally at the same time as the IFN injection and up to 12 hours or more if needed, in order to mitigate the expected IFN-dependent flu-like syndrome.

Primary Outcome(s)

Pharmacodynamics measured by the following variables: - Serum neopterin levels (values expressed in ng/mL). Time measurement: Before and 6, 12, 24, 48, 72, 96, 120, 168 and 192 hours after injection at each treatment period. - Serum?ß2-microglobulin (ß2M) (values expressed in µg/mL). Time measurement: Before and 6, 12, 24, 48, 72, 96, 120, 168 and 192 hours after injection at each treatment period. - 2',5' oligoadenylate synthetase (2',5' OAS) mRNA expression in peripheral blood (RNA concentration). Time measurement: Before and 6, 12, 24, 48, 72, 96, 120, 168 and 192 hours after injection at each treatment period.

Secondary Outcome(s)

Pharmacokinetics and clinical evaluation measures through the following variables: - Serum levels of interferon alpha and interferon gamma (values ??expressed pg/mL). Measuring time: at baseline and at 2, 3, 4, 6, 7, 8, 10, 12, 14, 16, 24, 36 and 48 hours after administration. - Vital signs (body temperature in degrees Celsius, heart rate in beats per minute, blood pressure in mm Hg and respiratory rate in breaths per minute). Measuring time: at baseline and at 2, 3, 4, 6, 7, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96, 120, 168 and 192 hours in each period. - Determination of hematology and clinical chemistry (numerical values ??as measurement units for each determination). Measuring time: at baseline and at 24, 48, 72, 96, 120, 168 and 192 hours after administration of interferons, in each period.

Secondary ID(s)

IG/IAG/FD/1101

Source(s) of Monetary Support

HeberBiotec S.A.

Secondary Sponsor(s)

Ministry of Public Health, Cuba.