Phase
Condition
Aging
Treatment
N/AClinical Study ID
Ages > 45 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Subjects must meet the following inclusion criteria at the screening visit.
Age of 45 years or older.
Subjects, or their authorized representatives, must be adequately informed andunderstand the nature and risks of the study and must be able to provide a signatureand date in the Informed Consent Form (ICF).
Women must undergo a negative serum pregnancy test at the screening assessment.
Subjects, or their representatives, must be able to communicate effectively with thestudy staff.
Subjects, or their authorized representatives, must certify that they are able andwilling to follow all protocol requirements and study restrictions.
Exclusion
Exclusion Criteria: Subjects are not eligible for the study if they meet any of the following criteria at thescreening visit, unless otherwise specified.
Subjects who have a history of allergy, hypersensitivity, or intolerance to anymedications, components, or excipients of the investigational product, which cannot beresolved by the staff conducting the study.
Female subjects who are pregnant, expected to become pregnant, or lactating/nursing.
Subjects who are sexually active and who are unwilling or unable to use a method ofeffective contraception (e.g., hormonal and/or barrier) during their participation inthe study.
Subjects who are intolerant of, or do not wish to receive, IV or IT injections.
Subjects who are currently alcoholics and/or use psychoactive substances.
Subjects who cannot tolerate venipuncture and/or venous access.
Subjects who have donated or had a significant loss of whole blood (480 ml or more)within 30 days, or donated plasma or platelets within 14 days prior to screening.
Subjects who have received blood or blood products within 30 days prior to screening.
Subjects who have been treated with another research product 30 days prior to thescreening assessment, or plan to participate in another clinical trial, while in thisstudy if in the opinion of the principal investigator, may place the subject at riskdue to participation in the study, or may influence the results of the study or thesubject's ability to complete the study. If more than 30 days have passed sinceparticipation in another clinical trial, the study staff must ensure that the subjecthas recovered from any adverse event (AE) associated with the research product used.
Subjects who have a history or evidence of active infection or febrile illness within 7 days prior to the screening assessment.
Subjects who have a history of any other clinically significant disease or disorderthat, in the opinion of the principal investigator, may place the subject at risk dueto participation in the study, or may influence the results of the study or thesubject's ability to complete the study.
Study Design
Study Description
Connect with a study center
IPS Arcasalud SAS
Zipaquirá, Cundinamarca 250251
ColombiaActive - Recruiting

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