Trials / Not Yet Recruiting
Not Yet RecruitingNCT06273553
A Study in Subjects With Human Papillomavirus 16 or 18 Associated Cervical Intraepithelial Neoplasia Grade 2 or 3
An Open-Label, Phase 1/2 Study to Evaluate the Safety, Tolerability, Immunogenicity and Efficacy of RG002 Injection (an mRNA Therapeutic Vaccine) in Subjects With Human Papillomavirus (HPV) 16 or 18 Associated Cervical Intraepithelial Neoplasia Grade 2 or 3 (CIN2/3)
- Status
- Not Yet Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 39 (estimated)
- Sponsor
- RinuaGene Biotechnology Co., Ltd. · Industry
- Sex
- Female
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to to evaluate the safety, tolerability, immunogenicity, and efficacy of RG002 Injection in subjects with HPV16/18 associated Cervical Intraepithelial Neoplasia Grade 2 or 3(CIN2/3).
Conditions
- Human Papillomavirus Associated Intraepithelial Neoplasia
- Cervical Intraepithelial Neoplasia Grade 2/3
- Human Papillomavirus Type 16 Infection
- Human Papillomavirus Type 18 Infection
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | RG002 injection | In Part A, there are three dose cohorts that are 25µg,75µg and 150µg. In Part B, there will 1 or 2 dose levels according to the results of Part A. All subjects will receive a total of three RG002 Injections, administered intramuscularly at assigned dose level, with a dosing frequency of every 2 weeks (D1, D15, and D29). |
Timeline
- Start date
- 2024-03-01
- Primary completion
- 2026-10-01
- Completion
- 2027-12-01
- First posted
- 2024-02-22
- Last updated
- 2024-02-22
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06273553. Inclusion in this directory is not an endorsement.