NCT07198555

A Clinical Study to Evaluate the Safety, Tolerability and Efficacy of BBM-A101 in the Treatment of Knee Osteoarthritis.

A Clinical Study to Evaluate the Safety, Tolerability and Efficacy of BBM-A101 in the Treatment of Knee Osteoarthritis .

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 81 (estimated)
• Sponsor: Belief BioMed (Beijing) Co., Ltd · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the safety, tolerability, and efficacy of BBM-A101 to treat participants with knee osteoarthritis.

Detailed description

This study is divided into two phases: Phase Ia and Phase Ib . Phase Ia is a randomized, single-blind study . Phase Ib is a randomized, double blind, parallel assignment study. BBM-A101 is an AAVbased gene therapy that delivers a therapeutic gene cassette into knee for the treatment of knee osteoarthritis.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DRUG	BBM-A101	Single-dose intra-articular （IA）injection （2ml）(phase Ia) Low dose group， Middle dose group； High dose group； Control group ：Placebo
DRUG	Placebo	Placebo(phase Ia)
DRUG	BBM-A101	Single-dose intra-articular （IA）injection （2ml）(phase Ib) Low dose group， High dose group Control group ：Placebo
DRUG	Placebo	Placebo（phase Ib）

Timeline

• Start date: 2025-10-09
• Primary completion: 2027-12-30
• Completion: 2031-12-30
• First posted: 2025-09-30
• Last updated: 2025-11-18

Locations

2 sites across 1 country: China