New pill HRS-2129 aims to ease knee arthritis pain
NCT ID NCT07351968
First seen Jun 25, 2026 · Last updated Sep 21, 2026 · Updated 3 times
Summary
This early-stage trial tests a new drug called HRS-2129 in 200 people with moderate to severe knee osteoarthritis pain. Participants will receive either HRS-2129, a placebo, or an active comparator (celecoxib) to see if it reduces pain and improves joint function. The study is double-blind, meaning neither patients nor doctors know who gets what, to ensure unbiased results.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HRS-2129 tablet
- What this could lead to
- If successful, this could lead to a new pain relief option for people with knee osteoarthritis.
- What could go wrong
- This is an early Phase 1 study with only 200 people, so it's too soon to know if HRS-2129 works or is safe. Many drugs fail at this stage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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202 people
The number who actually took part.
- Started
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Mar 2026
- Finished
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Jul 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Voluntarily sign the informed consent form before starting the activities related to the trial; 2. The Numerical Evaluation Scale (NRS) pain score of the index knee joint at screening is ≥ 4; 3. Subjects must be willing to discontinue all medical and non-medical treatments for osteoarthritis pain except rescue medication (acetaminophen) and not use prohibited analgesics throughout the study ; 4. Male and female subjects of childbearing potential must agree to use highly effective contraceptive measures with their partners from the signing of the informed consent form until 1 month after the last dose of investigational product. Exclusion Criteria: 1. History of other diseases that may involve the target joint; 2. History of major trauma or surgery of knee joint and hip joint in the past year; 3. Plan to undergo surgical procedure during the study; 4. Most or complete loss of mobility; 5. There are other diseases that may confuse the assessment of osteoarthritis pain; 6. There is a neuropsychiatric disease, and the investigator's assessment may affect the evaluation of osteoarthritis (OA) or self-score; 7. There are serious or poorly controlled concomitant diseases; 8. Those who have a clear history of peptic ulcer, bleeding, perforation or obstruction within 1 year before screening, and have been clinically diagnosed; 9. Those who require drug treatment or surgical intervention; 10. History of malignant tumors within 5 years before screening; 11. Have a history of drug abuse, drug abuse and/or alcoholism within 2 years before screening.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Drum Tower Hospital affiliated to Nanjing University School of Medicine
Nanjing, Jiangsu, 210005, China