Human Papilloma Virus 16 Peptide vaccin Fluorescence Pharmacokinetics
Conditions
Interventions
HPV-NIRD1 contains HPV-16 E6 peptide 71-95 conjugated to Near-Infrared Dye 1 and has been manufactured at the Interdivisional GMP Facility LUMC (IGFL) of the department of Clinical Pharmacy and Toxico
Sponsors
Centre for Human Drug Research (CHDR)
Leiden University Medical Center (LUMC)
Eligibility
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, 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 HPV-NIRD1.Pre-menopausal female subjects who are not surgically sterile should also employ an effective method of birth control for at least three months post dosing. 4. The subject¡¦s body mass index is 18-22 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.
Exclusion criteria
Exclusion criteria: 1. The subjects uses prescription drugs or OTC-drugs that may have an impact on the study objectives. 2. Previous exposure to the investigational drug. 3. Participation in a clinical trial within 90 days of screening or more than 4 times in the previous year. 4. Known hypersensitivity to the investigational drug or comparative drug or drugs of the same class, or any of their excipients. 5. Any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment-emergent (serious) adverse events ((S)AEs); concomitant medication; clinical laboratory tests (haematology, chemistry, urinalysis); vital signs (pulse rate, systolic blood pressure, diastolic blood pressure); injection site status; physical examination findings. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following endpoints will be determined for HPV-NIRD1 following administration, they will be derived by imaging of injection site and draining inguinal lymph nodes: „X Absolute fluorescent signal of injection site or draining inguinal lymph node at different time points and doses „X SBR (signal to background ratio), defined as fluorescent signal of injection site or draining inguinal lymph node compared to fluorescence signal of tissue surrounding the injection side or lymph node, at different time points and doses. | — |
Contacts
Public ContactJ. Burggraaf
Center for Human Drug Research, Zernikedreef 10
Outcome results
None listed