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

Detailed criteria

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

Biological
NWRD09
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)
Biological
Placebo
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 Center
New York, New York
irboffice@columbia.edu 212-305-3410

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

Summary

Eligibility

Interventions

Location

Compensation

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Details

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