CIGB500 in healthy volunteers

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000017
• Date of registration: 20/12/2010
• Primary sponsor: Center for Genetic Engineering and Biotechnology (CIGB), Havana City
• Public title: CIGB500 in healthy volunteers
• Scientific title: Administration of CIGB500 in healthy volunteers. Phase I study on scaling up dosages.
• Date of first enrolment: 11/12/2007
• Target sample size: 18
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000017-En
• Study type: Interventional
• Study design: Randomization: Nonrandomized Trial Blinding: Open. Placebo: Uncontrolled Assignment: Other Purpose: Other Other design features: Dose escalations

Countries of recruitment

Cuba

Contacts

• Name: Francisco Hernández-Bernal
• Affiliation: Center for Genetic Engineering and Biotechnology.

• Name: Francisco Hernández-Bernal
• Affiliation: Center for Genetic Engineering and Biotechnology.

Key inclusion & exclusion criteria

Inclusion criteria: Male individuals of 18 to 35 years of age. Absence of important clinical signs during the interrogation and in the physical examination. Normal Electrocardiogram. Analysis of hematology, plasmatic biochemistry and urine within the normal limits. Normal body weight according to height. Willingness of the individual shown by signing the written consent.
Exclusion criteria: History of endocrine-metabolic alterations. History of significant acute diseases in the last 30 days. History of chronic diseases (cardiovascular, respiratory, neurological, renal, respiratory, gastrointestinal, liver or hematological diseases). Administration of a pharmaceutical under study within 45 of having entered the study. Use of some medicine within 15 days before having entered the study. Donation or loss of blood greater than 400 mL within 12 weeks before entering the study. Severe adverse reactions or hypersensitivity to a drug. History of alcoholism or alcohol consumption within 24 before the administration of the drug. Consuming more than 10 cigarettes a day.

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

Health Condition(s) or Problem(s) studied

Healthy volunteers

Intervention(s)

Administration at a single dose through the endovenous route at 6 scale levels of the doses: 1, 10, 50, 100, 200 and 400 µg/kg.

Primary Outcome(s)

Clinical Adverse events. The type, duration, intensity, severity, causal relation and therapeutic conduct. For this, the subject has been evaluate through their interrogation and physical examination, at least at the start, at 24 hours, 48 hours, 72 hours and at 10 days after applying the product, but also at any moment in which any event was observed. Vital signs. Blood pressure, heart rate, respiratory rate and axillar temperature. Although these variables also form part of the evaluations of the clinical adverse events, a separate section has been includ since they were strictly followed during and after the application of the product. The records of the vital signs were carried out at the start after the administration of the product at 30 minutes and at 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 and 72 hours. Electrocardiogram (ECG). An electrogradiograph monitoring has been perform during the first 24 hours after the administration of the product using the standard calibration of 10mm=1mV and the speed of the paper at 25 mm/second. The first evaluation was at the start in an interval of 30 minutes before the administration of the product and after applying it the records were taken at the following times: 30 minutes and at 1, 2, 4, 6, 8, 10, 12 and 24 hours. Laboratory tests. The samples for the determinations have been collect while fasting as part of the pre-entrance examination, at 72 hours and at 10 days.

Secondary Outcome(s)

Pharmacokinetics of the CIGB500 (only the doses of 100 _g/kg, 200 _g/kg and 400 _g/kg): The blood samples have been extract before the administration and after concluding the administration), 10, 20 and 30 minutes; and at 1, 2, 4, 6, 8, 10, 12, 24, 48 and 72 hours. Pharmacodynamic effects: Blood samples have been take immediately before administering the product and at 10, 20 and 30 minutes, as well as after one hour, 2 and 24 hours. Echocardiograms Studies: On the pre-entrance examinations, at 72 hours and 10 days before administering the product.

Secondary ID(s)

IG/CIGB500I/SG/0601

Source(s) of Monetary Support

Heber Biotec S.A.

Secondary Sponsor(s)

Not applicable