A phase 1, randomized, double blind, placebo-controlled, single and repeated ascending dose study to assess safety, tolerability and pharmacokinetics of ZW800-1 injected intravenously into healthy volunteers
- Conditions
- CancerMalignant tumors1002765510038365
- Registration Number
- NL-OMON45587
- Lead Sponsor
- Centre for Human Drug Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method