Research into the effects of Tacrolimus on the immune system in healthy volunteers

Completed

• Conditions: Kidney transplantation, niertransplantatie

• Registration Number: NL-OMON20026
• Lead Sponsor: Centre for Human Drug Research (CHDR)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

1. Willing to give written informed consent and willing and able to comply with the study protocol;

2. Healthy male or female subjects, 18 to 55 years of age (inclusive) at screening. The health status is verified by absence of evidence of any clinical significant active or uncontrolled chronic disease following a detailed medical history and a complete physical examination including vital signs, laboratory measurements and 12-lead ECG;

Exclusion Criteria

1. Any disease associated with immune system impairment, including auto-immune diseases, HIV, any confirmed history of severe allergic reaction and transplantation patients;

2. Evidence of any other active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator. Minor deviations from the normal range may be accepted, if judged by the Investigator to have no clinical relevance;

Study & Design

• Study Type: Interventional
• Study Design: Not specified