NCT07536282

Evaluation of NWRD09 for Female Participants With Persistent HPV16 Infection

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

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Newish Biotech (Wuxi) Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Persistent HPV16 Infection

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2026-10-01
• Primary completion: 2027-09-01
• Completion: 2027-11-01
• First posted: 2026-04-17
• Last updated: 2026-04-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study