NCT07198555 A Clinical Study to Evaluate the Safety, Tolerability and Efficacy of BBM-A101 in the Treatment of Knee Osteoarthritis.
| NCT ID | NCT07198555 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Belief BioMed (Beijing) Co., Ltd |
| Condition | Knee Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 81 participants |
| Start Date | 2025-10-09 |
| Primary Completion | 2027-12-30 |
Trial Parameters
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Brief Summary
The purpose of the study is to evaluate the safety, tolerability, and efficacy of BBM-A101 to treat participants with knee osteoarthritis.
Eligibility Criteria
Inclusion Criteria: 1. Participants with moderate knee osteoarthritis . 2. The knee joint was evaluated as having Kellgren-Lawrence grade 2 or 3. 3. The Body Mass Index (BMI) ranges from 18.0 to 35.0 kg/m2 (including the boundary values). 4. Lower titers of antibodies binding to the BBM-A101 capsid in the blood. 5. Participants who had received adequate treatment with conventional medications previously, experienced recurrence or aggravation of target knee arthritis after discontinuation of medication, and still had moderate pain; during the screening period, the WOMAC pain score of the target knee was ≥ 8 . 6. From the time of screening to 52 weeks after dosing , the participants had no intention of having children and voluntarily took effective contraceptive measures, and there were no plans for sperm donation or ova donation. 7. Voluntarily sign the informed consent form and be able to complete the research as required by the clinical trial protocol. \- Exclusion Criteria: 1. There