Evaluation of NWRD09 for Female Participants With Persistent HPV16 Infection

Part of paid clinical trials in New York, New York.

Sponsor: Newish Biotech (Wuxi) Co., Ltd.
Study ID: NCT07536282
Phase: PHASE1/PHASE2
Status: Not Yet Recruiting

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Conditions

Persistent HPV16 Infection

Eligibility Criteria

Sex: FEMALE
Age: 18 Years - 60 Years
Healthy Volunteers: Not accepted

Interventions

NWRD09 — BIOLOGICAL
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)
Placebo — BIOLOGICAL
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)

Study Details

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.

Key Dates

Start date: Oct 31, 2026
Status verified: Apr 2026
Primary completion: Sep 30, 2027
Completion: Nov 30, 2027

Study Design

Enrollment: 78 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Experimental: NWRD09
Predefined dose groups of NWRD09
Placebo Comparator: Placebo

Primary Outcome Measure

Incidence and severity of local and systemic adverse events (AEs). [ Time Frame: Up to Week 28 ]

Central Contacts

June Y. Hou, MD
212-305-3410
[email protected]

Locations (1)

Facility	City	State	ZIP	Site coordinators
Columbia University Medical Center	New York	New York	10032	June Y. Hou, MD [email protected] 212-305-3410 June Y. Hou, MD (PRINCIPAL_INVESTIGATOR)

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By research site

Columbia University Medical Center· New York, NY