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

NCT07198555 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2025-11-18

No results posted yet for this study

Summary

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

Conditions

Interventions

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）

Sponsors & Collaborators

  • Belief BioMed (Beijing) Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Jie Zhao · The Ninth People's Hospital of Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-09
Primary Completion
2027-12-30
Completion
2031-12-30

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07198555 on ClinicalTrials.gov