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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age40-75
SponsorBelief BioMed (Beijing) Co., Ltd

About this trial

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

Eligibility criteria

Qualifiers

Participants with moderate knee osteoarthritis .

The knee joint was evaluated as having Kellgren-Lawrence grade 2 or 3.

The Body Mass Index (BMI) ranges from 18.0 to 35.0 kg/m2 (including the boundary values).

Lower titers of antibodies binding to the BBM-A101 capsid in the blood.

Disqualifiers

There is a possibility of secondary knee osteoarthritis, or the knee joint symptoms may not be caused by knee osteoarthritis, or there may be other medical histories of diseases that other researchers believe could potentially lead to knee osteoarthritic inflammation.

History of lumbar dischernaiation, accompanied by lower limb nerve symptoms that may affect the assessment of the study.

Participants who are unable or unwilling to undergo MRI examination, or who have contraindications to MRI.

Participants who are unable or unwilling to undergo joint fluid extraction.

Trial design

Treatments tested in this trial

  • BBM-A101
  • Placebo
  • BBM-A101
  • Placebo

Treatment groups

81 Participants
are divided into 2 treatment groups