Double-blind, placebo-controlled phase 1 trial of nizaracianine administered in three divided doses to healthy volunteers

Completed

Conditions: Preventing iatrogenic ureteral damage preventing unneccessary damage to urinary tract
10046590

Registration Number: NL-OMON51504

Lead Sponsor: Curadel Surgical Innovations, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 21

Inclusion Criteria

1. Subject is 18-55 years old at screening (inclusive).
2. Subject is able and willing to comply with study procedures.
3. Subject is in good general health, according to the investigator*s judgement
based on vital signs, medical history, physical examination, and laboratory
tests performed.
4. Body mass index between 18-32 kg/m2 (inclusive) and with a minimum body
weight of 50 kg at screening.
5. An estimated GFR >= 90.
6. Female subjects need to be surgically sterile, post-menopausal or
pre-menopausal with a negative urine pregnancy test at screening and before
administration of nizaracianine. Pre-menopausal female subjects who are not
surgically sterile have to agree to use an effective method of contraception.
7. Subject*s screening ECG and clinical laboratory test results are within
normal limits, or if any are outside of normal limits they are considered to be
clinically insignificant.
8. Subject has negative test results for drug and alcohol screening.
9. Written informed consent must be given prior to any study activities,
according to ICH/GCP and national/local regulations.

Exclusion Criteria

1. (A history of) any clinically significant medical condition or
abnormalities, as judged by the investigator, in physical examination,
laboratory test results (including chemistry panel with hepatic and renal
panels, complete blood count, and urine dipstick) or electrocardiography (ECG)
at screening. In the case of uncertain or questionable results, tests performed
during screening may be repeated to confirm eligibility or judged by the
investigator to be clinically irrelevant for healthy subjects.
2. Female subjects that are lactating or pregnant.
3. The subject has a positive screening test for hepatitis B, hepatitis C, and
human immunodeficiency virus.
4. Use of any prescription medication and any other substance that in the
opinion of the investigators may influence the outcome of the study within 7
days prior to study drug administrations, or less than five half-lives
(whichever is longer, and during the course of the study).
5. Previous inclusion in this study.
6. Participation in a clinical trial within 3 months or 5 half-lives, whichever
is longer.
7. Use of alcohol during the 24 hours prior to screening and/or an
unwillingness to abstain from alcohol consumption during the stay at the
clinical unit, and for at least 24 hours prior to each study visit;
8. Positive urine drug screen or alcohol test at screening and/or at first
study day.
9. History of anaphylactic reactions to a prescription drug, over-the-counter
drug, or herbal supplement.
10. Prior organ transplant.
11. Signs of moderate or severe symptoms of prostate hypertrophy
12. Loss or donation of blood over 500 mL within four months prior to
screening.
13. Any other condition that in the opinion of the investigator would
complicate or compromise the study or the well-being of the subject.
14. History of AV blocks or any type of AV block on the ECG at the screening
15. History of syncope