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

ConditionKnee 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • BBM-A101

    Drug

    Single-dose intra-articular （IA）injection （2ml）(phase Ia) Low dose group， Middle dose group； High dose group； Control group ：Placebo

  • Placebo

    Drug

    Placebo(phase Ia)

  • BBM-A101

    Drug

    Single-dose intra-articular （IA）injection （2ml）(phase Ib) Low dose group， High dose group Control group ：Placebo

  • Placebo

    Drug

    Placebo（phase Ib）

Treatment groups

81 Participants
are divided into 2 treatment groups
Group A: Arm of PlaceboPlacebo comparator 1 intervention
Group B: Arm of BBM-A101Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of dose limiting toxicity (DLT) events

Time frame
within 4 weeks
2

Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

To evaluate the safety of BBM-A101 by AEs and SAEs.

Time frame
within 52 weeks

Secondary outcomes

1

The protein levels of gene expression products in blood and joint fluid

Time frame
within5 years
2

The shedding of recombinant adeno-associated virus (rAAV) vectors in peripheral blood, joint fluid, urine, feces, saliva, and semen

Time frame
within 5 years
3

The change in the joint space width as detected by X-ray of the knee joint compared to the baseline

Time frame
within 5 years
4

The changes in the titers of AAV capsid-binding antibodies in the blood and joint fluid compared to the baseline level

Time frame
within 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Belief BioMed (Beijing) Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
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