A Phase I/IIa, Randomized, Double Blind, Placebo Controlled, Dose Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of NWRD09 Injection in Female Participants With Persistent HPV16 Infection
Newish Biotech (Wuxi) Co., Ltd.
Summary
This is a two-part, phase I/IIa study, intended to evaluate the safety, tolerability, immunogenicity, and efficacy of NWRD09 in female participants with persistent HPV16 infection, and to determine the MTD, and/or RP2D of NWRD09.
Eligibility
- Age range
- 18–60 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Participants who have fully understood the study, able and willing to comply with all study procedures, and voluntarily sign written ICF; * Female participants aged 18-60 years (inclusive) at the time of signing the ICF; * Persistent HPV16 infection, defined as virologically confirmed HPV16 positivity persisting for ≥ 6 months before screening (e.g., participants must provide investigator-approved evidence of HPV16 infection ≥ 6 months prior to screening and be HPV16 positive at the time of screening); * Participants must have a confirmed cytological results of atypical…
Interventions
- BiologicalNWRD09
Participants will receive 4 injections of NWRD09 via IM to the lateral deltoid region of the upper arm, at D1 (W0D1), D15 (W2D1), D29 (W4D1) and D85 (W12D1)
- BiologicalPlacebo
Participants will receive 4 injections of Placebo via IM to the lateral deltoid region of the upper arm, at D1 (W0D1), D15 (W2D1), D29 (W4D1) and D85 (W12D1)
Location
- Columbia University Medical CenterNew York, New York