Pharmacokinetic analysis of HPV16 synthetic long peptide vaccination in healthy volunteers using optical imaging

Completed

• Conditions: HPV16 associated cancer; HPV / cancer; human papillomavirus; malignant tumors; 10027655

• Registration Number: NL-OMON42729
• Lead Sponsor: Centre for Human Drug Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 6

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified