Testing a new medication for moderate to severe knee osteoarthritis pain

Plain-English translation of NCT07351968 on ClinicalTrials.gov ↗ · Source last updated March 2026 · Translation generated June 2026 · How we translate trials

Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.

What is this trial?

This is a Phase 1b clinical trial testing a new medication called HRS-2129 to treat moderate to severe knee osteoarthritis pain. The trial will compare how well HRS-2129 works at two different doses against both a placebo (inactive pill) and celecoxib, a pain medication you may already know. Researchers want to understand whether this new treatment is effective and safe for people dealing with significant knee pain.

Knee osteoarthritis causes millions of people chronic pain, and current treatment options don't always work well for everyone. This trial is testing whether this medication could be a better option for people with moderate to severe knee pain who need relief.

Do you qualify?

You likely qualify if…

you have moderate to severe knee osteoarthritis pain (a score of 4 or higher on a pain scale)
you are willing to stop other arthritis treatments (except acetaminophen for rescue pain relief) during the trial
you agree not to use other pain medications besides what the trial allows
you are willing to use effective contraception if you could become pregnant, from enrollment through one month after your last dose

You likely don't qualify if…

you have had major knee or hip surgery or injury in the past year
you have a serious stomach or bleeding condition, or a history of peptic ulcers or stomach bleeding in the past year
you have cancer or a history of cancer in the past 5 years
you have a history of substance abuse or alcoholism in the past 2 years
you have serious medical conditions that are not well controlled, or psychiatric conditions that might affect your ability to report pain accurately

What participation looks like

If you qualify, you will be randomly assigned to receive either the new medication HRS-2129 (at one of two doses), celecoxib, or a placebo. You'll take your assigned treatment for a set period while attending study visits where researchers will check your pain levels, take blood samples to understand how the medication works in your body, and monitor you for any side effects. The trial will track whether your knee pain improves and whether the treatment is safe.

AI-generated summary from trial data · Jun 9, 2026 · Not medical advice

Trial locations(1 site)

China

Drum Tower Hospital affiliated to Nanjing University School of Medicine, Nanjing, Jiangsu