NWRD08 DNA Plasmid for HPV-16 and/or HPV-18 Related Cervical HSIL (NCT06276101) | Clinical Trial Compass
UnknownPhase 1
NWRD08 DNA Plasmid for HPV-16 and/or HPV-18 Related Cervical HSIL
China9 participantsStarted 2024-01-25
Plain-language summary
This is a single-arm, open label, multi-center Phase 1 clinical study to evaluate the safety and tolerability of HPV-16 and HPV-18-targeted DNA plasmid vaccine (NWRD08) in patients HPV-16 and/or HPV-18 related cervical HSIL.
Who can participate
Age range18 Years – 60 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. The electrocardiograms deemed normal or with abnormalities not considered clinically significant by the site investigators.
✓. Major organ functions were normal within 1 week before the first NWRD08 administration: 1) Blood routine: Hemoglobin (Hb) ≥100 g/L; Platelet count (PLT) ≥75×109/L; 2) The liver: Total bilirubin (TB) ≤1.5× upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; Plasma albumin ≥30 g/L; 3)Kidney: Serum creatinine (Scr) ≤1.5×ULN, or creatinine clearance ≥40 mL/min (serum creatinine \> 1.5 x ULN);
✓. Within 1 week before the first NWRD08 administration, women of childbearing age must have a negative serum pregnancy test and consent to use effective contraception form the signing of the ICF to the end of the study.
✓. Have fully understood the study and voluntarily signed the ICF, have good communication with the investigator, and are able to complete all treatments, examinations, and visits stipulated in the study protocol.
Exclusion criteria
✕. Microscopic or gross evidence of adenocarcinoma-in-situ (AIS), high grade vulvar, vaginal, or anal intraepithelial neoplasia or invasive cancer in any histopathologic specimen at screening;
✕. Pregnant, breastfeeding or considering becoming pregnant during the study;
✕. Administration of any non-live vaccines within 2 weeks prior to the first NWRD08 administration;
What they're measuring
1
Safety
Timeframe: From first administration of NWRD08 to 24 weeks (Week36) after the last administration.
2
Dose-limiting toxicity (DLT)
Timeframe: From first administration of NWRD08 to 28 days after the last administration