A phase 1, randomized, double blind, placebo-controlled, single ascending dose study to assess safety, tolerability and pharmacokinetics of cRGD-ZW800-1 intravenous injection in healthy volunteers
- Conditions
- CancerMalignant tumors10027655
- Registration Number
- NL-OMON43465
- Lead Sponsor
- Centre for Human Drug Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 11
1. The subject is 18-65 years old at screening.
2. The subject is able and willing to comply with study procedures, and signed and dated informed consent is obtained before any study-related procedure is performed.
3. Female subjects need to be either surgically sterile, post-menopausal or pre-menopausal with a negative urine pregnancy test at screening and just before administration of cRGD-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*s body weight is <=90 kg and the body mass index is <=30 kg/m2.
5. 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).
6. 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.
7. The subject has negative screening test results for hepatitis B, hepatitis C, and human immunodeficiency virus.
8. The subject has negative test results for drug and alcohol screening.
9. 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.
10. 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
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety and tolerability is the primary endpoint of the study. This will be<br /><br>assessed from data on the occurrence of treatment-emergent adverse events<br /><br>(TEAEs) from the time of administration throughout the study period, and<br /><br>changes in serum biochemistry, hematology, urinalysis, vital signs, ECG,<br /><br>injection site status, and physical examination findings. In addition, analysis<br /><br>of the PK of cRGD-ZW800-1 will be conducted.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Not Applicable</p><br>