CIGB500 in healthy volunteers

Phase 1

• Conditions: Healthy Volunteers; Healthy volunteers

• Registration Number: RPCEC00000017
• Lead Sponsor: Center for Genetic Engineering and Biotechnology (CIGB), Havana City

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 18

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified