A Phase I Clinical Trial to Assess the Safety and Immunogenicity of DX-104
A randomized, double-blinded, positive-controlled clinical trial will be conducted to observe the safety and immunogenicity of DX-104 in adults 18 to 50 years of age.
| Condition(s) | Neisseria Meningitidis Serogroup B |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | A randomized, double-blinded, positive-controlled clinical trial will be conducted to observe the safety and immunogenicity of DX-104 in adults 18 to 50 years of age. |
| Who can participate | Inclusion Criteria 1. Healthy male or female participants aged 18 to 50 years (inclusive) at the time of screening, who can provide valid legal identification. 2. Willing and able to give written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects. 3. Willing and able to comply with all study procedures and available for the entire duration of the study follow-up. 4. Participants must have a Body Mass Index (BMI) between ≥18.0 and ≤32.0 kg/m2 at screening. 5. For female participants at least 1 of the following conditions must apply: i) Is not of childbearing potential (WONCBP), defined as surgically sterile (hysterectomy, bilateral salpingectomy, tubal liga |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Shanghai Yuguan Biotech Co., Ltd.（Delonix Bioworks) |
| Locations | Perth, Western Australia, Australia |
| Start date | 2026-03-20 |
| NCT ID | NCT07395739 |
| Official listing | https://clinicaltrials.gov/study/NCT07395739 |