CIGB500 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:

Administration of CIGB500 in healthy volunteers. Phase I study on scaling up dosages.

Secondary indentifying numbers:

IG/CIGB500I/SG/0601

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB), Havana City

Source(s) of monetary or material support:

Heber Biotec S.A.

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 the Quality of Drugs(CECMED)

Authorization date :

28/08/2007

Reference number:

1657/06.033.07B

Principal investigator

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

First name:

Angel Abreu Cruz, MD Marbelia Iglesias González, MD Anselmo Abdo Cuza, MD

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

País:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered

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

Research ethics committees:

Medical – Surgical Research Center, Havana, July 18, 2007.

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

11/12/2007

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:

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.

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):

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.

Key secondary outcomes:

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.

Selection criterias

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

Gender:

Male

Minimum age:

18 years

Maximum age:

35 years

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.

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

Allocation:

Non-randomized controlled trial

Masking:

Open

Control group:

Uncontrolled

Study design:

Other

Other design:

Dose escalations

Phase:

1

Target sample size:

18

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:

Francisco

Last Name:

Hernández-Bernal

Affiliation:

Center for Genetic Engineering and Biotechnology.

Postal Address:

Ave. 31 e/ 158 y 190 Cubanacán, Playa

City:

Havana City

País:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2085887

Email :

hernandez.bernal@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:

Francisco

Last Name:

Hernández-Bernal

Affiliation:

Center for Genetic Engineering and Biotechnology.

Postal Address:

Ave. 31 e/ 158 y 190 Cubanacán, Playa

City:

Havana City

País:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2085887

Email :

hernandez.bernal@cigb.edu.cu

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:

RPCEC00000017

Date of Registration in Primary Registry:

2010-12-20

Record Verification Date:

2008-01-09 19:00

Link to the spanish version:

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CIGB500 in healthy volunteers

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