Lubricin-inspired Osteoarthritis Treatment: a Unique Solution

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorPleryon Therapeutics (Hangzhou) Limited

About this trial

This goal of this open label study is to evaluate the safety and tolerability of a single intra-articular administration of ABR1 in adults with knee osteoarthritis with a KL grade from 2 to 4. The primary questions it aims to answer are:

1. Is ABR1 safe to use as an intraarticular injection for participants with knee osteoarthritis? 2. What medical problems do participants have after receiving a single injection of ABR1?

Participants will receive a single injection of ABR1 to the knee with osteoarthritis. Participants will

1. Keep a stable pain treatment regimen 2. Visit the clinic at 1 week, 4 weeks, 8 weeks, and 12 weeks post injection 3. Keep a diary of their symptoms and number of times they use a rescue medication for their knee pain.

Eligibility criteria

Qualifiers

Male or female at least 40years of age

Knee OA with Kellgren-Lawrence (KL) Grade 2 to 4 of the target knee on X-ray

Inadequate pain relief with 1st line treatment, consisting of any of the following

conservative non-pharmacological treatment AND/OR

Disqualifiers

Pregnant or lactating

Other significant knee pathologies of target knee from medical history or radiographic method(s)

Severe malalignment > 10 degree in the target knee (either varus or valgus) measured using standardized knee x-ray at screening or based on previous medical records

Severe inflammatory arthritis or other joint disease with warm, red, and swollen knee in the target knee

Trial design

Treatments tested in this trial

  • ABR1

Treatment groups

25 Participants
are divided into 1 treatment group