Cancer Malignant tumors
Conditions
Interventions
Intravenous administration of ZW800-1 and fluorescence imaging.
Pharmacokinetics
Safety
Tolerability
ZW800-1
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. The subject is 18-65 years old at screening. 2. The subject is able and willing to comply with study procedures. 3. Female subjects need to be surgically sterile, post-menopausal or pre-menopausal with a negative urine pregnancy test at screening and just before administration of ZW800-1. Pre-menopausal female subjects who are not surgically sterile should also employ an effective method of birth control for at least 90 days post dosing when it consists of a hormonal contraceptive method or IUD. For other contraceptive methods premenopausal females who are not surgically sterile have to agree to use an effective method of contraception. 4. The subject has a normal or clinically acceptable medical history, physical examination, and vital signs findings at screening (within 21 days before administration of study drug). 5. The 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. 6. The subject has negative screening test results for hepatitis B, hepatitis C, and human immunodeficiency virus. 7. The subject has negative test results for drug and alcohol screening. 8. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial. 9. Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
Exclusion criteria
Exclusion criteria: 1. Female subjects that are lactating or pregnant. 2. Unacceptable known diagnoses or diseases at baseline, e.g., known cardiovascular or pulmonary disease, renal or liver dysfunction, ECG or laboratory abnormalities, etc. 3. Use of prescription drugs, with the exception of contraceptive drugs. 4. Previous inclusion in this study. 5. Participation in a clinical trial within 90 days of screening or more than 4 times in the previous year. 6. History of anaphylactic reactions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability endpoints - Treatment-emergent (serious) adverse events ((S)AEs). - Clinical laboratory tests (urinalysis, serum biochemistry, hematology) Vital signs o Pulse Rate (bpm) o Systolic blood pressure (mmHg) o Diastolic blood pressure (mmHg) - ECG (heart rate (bpm), PR, QRS, QT, QTcB, QTcF) - Injection site status - Physical examination findings PK endpoints - The following endpoints will be determined for ZW800-1 following each treatment. They will be derived by non-compartmental analysis of the serum concentration-time data: o The area under the plasma concentration-time curve from zero to infinity (AUC0-inf); o The maximum plasma concentration (Cmax); o The area under the plasma concentration-time curve from zero to t of the last measured concentration above the limit of quantification (AUC0-last); o The time to reach maximum plasma concentration (tmax); o The terminal disposition rate constant (*z) with the respective half-life (t*). o Other parameters, including Vz, CL, and other parameters as appropriate, as well as dose adjusted parameters, may be determined. o Urinary excretion of ZW800-1 at specific time points (see table 1). - Fluorescence intensity of the skin over time | — |
Secondary
| Measure | Time frame |
|---|---|
| N.A. | — |
Countries
The Netherlands
Outcome results
None listed