Moderate Pain in Knee OsteoarthritisPhase 1NCT07351968

A Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis

A Phase 1 study testing HRS-2129 Tablet and Celecoxib capsule in people with Moderate Pain in Knee Osteoarthritis and Severe Pain in Knee Osteoarthritis, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Primary Objective: To explore the effectiveness of different doses of HRS-2129 in the treatment of patients with moderate to severe pain in knee osteoarthritis. Secondary Objectives: To evaluate the safety of different doses of HRS-2129 for the treatment of patients with moderate to severe pain in knee osteoarthritis… Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Moderate Pain in Knee Osteoarthritis, Severe Pain in Knee Osteoarthritis
What is being tested?: HRS-2129 Tablet and Celecoxib capsule
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 202 participants
Where: 1 siteChina
Study dates: 10 Mar 2026to 17 Jul 2026
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Voluntarily sign the informed consent form before starting the activities related to the trial;
The Numerical Evaluation Scale (NRS) pain score of the index knee joint at screening is ≥ 4;
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 ;
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.

Who cannot join

History of other diseases that may involve the target joint;
History of major trauma or surgery of knee joint and hip joint in the past year;
Plan to undergo surgical procedure during the study;
Most or complete loss of mobility;
There are other diseases that may confuse the assessment of osteoarthritis pain;
There is a neuropsychiatric disease, and the investigator's assessment may affect the evaluation of osteoarthritis (OA) or self-score;

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There are serious or poorly controlled concomitant diseases;
Those who have a clear history of peptic ulcer, bleeding, perforation or obstruction within 1 year before screening, and have been clinically diagnosed;
Those who require drug treatment or surgical intervention;
History of malignant tumors within 5 years before screening;
Have a history of drug abuse, drug abuse and/or alcoholism within 2 years before screening.

Trial locations and contacts

1 site in 1 country.

China1 site

Drum Tower Hospital affiliated to Nanjing University School of Medicine
Nanjing, Jiangsu, 210005

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Agent-positive and Placebo-controlled, Parallel-group Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis

Conditions: Moderate Pain in Knee Osteoarthritis, Severe Pain in Knee Osteoarthritis
Being tested: HRS-2129 Tablet, Celecoxib capsule, Celecoxib Capsule Placebo, HRS-2129 Tablet Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HRS-2129 TabletDrug
HRS-2129 tablet.
Celecoxib capsuleDrug
Celecoxib capsule.
Celecoxib Capsule PlaceboDrug
Celecoxib capsule placebo.
HRS-2129 Tablet PlaceboDrug
HRS-2129 tablet placebo.

Study groups in NCT07351968
Study group	Role	What they receive
HRS-2129 High Dose Group	Experimental	HRS-2129 high dose group. Receives: Drug: HRS-2129 Tablet; Drug: Celecoxib Capsule Placebo; Drug: HRS-2129 Tablet Placebo
HRS-2129 Low Dose Group	Experimental	HRS-2129 low dose group. Receives: Drug: HRS-2129 Tablet; Drug: Celecoxib Capsule Placebo; Drug: HRS-2129 Tablet Placebo
Celecoxib Group	Active comparator	Celecoxib group. Receives: Drug: Celecoxib capsule; Drug: HRS-2129 Tablet Placebo
Placebo Group	Placebo comparator	Placebo group. Receives: Drug: Celecoxib Capsule Placebo; Drug: HRS-2129 Tablet Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale scores.
Measured: At week 4.

Secondary outcomes (10)

Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale scores.
Measured: From baseline to Week 1, 2 and 3.
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) joint function subscale scores.
Measured: From baseline to Week 1, 2, 3 and 4.
Change from baseline in the weekly mean (Week 1, 2, 3 and 4) of the index Knee Numerical Rating Scale (NRS) pain score (resting).
Measured: From baseline to Week 1, 2, 3 and 4.
Change from baseline in the weekly mean (Week 1, 2, 3 and 4) of the index Knee Numerical Rating Scale (NRS) pain score (flat walking).
Measured: From baseline to Week 1, 2, 3 and 4.
Change from baseline in the overall patient global assessment (PGA) of osteoarthritis condition using the 5-point Likert scale.
Measured: From baseline to Week 1, 2, 3 and 4.
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale scores.
Measured: From baseline to Week 1, 2, 3 and 4.
Change from baseline in total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score.
Measured: From baseline to Week 1, 2, 3 and 4.
Treatment response: WOMAC pain subscale scores decreased by ≥ 30%, ≥ 50%, ≥ 70% from baseline.
Measured: At Week 1, 2, 3 and 4.
Adverse events (AEs) occurred during the study.
To evaluate the safety and tolerability of HRS-2129 tablets.
Measured: During the study, approximately 8 months.
Serious adverse events (SAEs) occurred during the study.
To evaluate the safety and tolerability of HRS-2129 tablets.
Measured: During the study, approximately 8 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Mar 202617 Jul 2026

First posted20 Jan 2026
Study start10 Mar 2026
Primary completion17 Jul 2026
Study completion17 Jul 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Moderate Pain in Knee OsteoarthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Comparison between HRS-2129 high dose group, HRS-2129 low dose group, Celecoxib positive control group, and Placebo control group.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 202 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07351968
Sponsor's protocol ID: HRS-2129-106
Status last verified: Sep 2026
First submitted: 11 Jan 2026
Last updated: 21 Sep 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Cartilage Biomarker Response to Acute Mechanical Loading in Women With Knee Osteoarthritis: Comparison by Antiresorptive Treatment Status
Knee Osteoarthritis
Recruiting
Patient Pain and Function in Medial Knee Osteoarthritis After Anteromedial vs Anterolateral Intra-Articular Corticosteroid Injection
Osteoarthitis, Osteoarthritic Knee Pain
Active, not recruiting
Effect of Autologous Ear Cartilage Micrografting in Knee Osteoarthritis
Osteoarthritis, Osteoarthritis (OA) of the Knee
Not yet recruiting
The Efficacy and Safety Study of 2107 Injection in Subjects With Mild to Moderate Knee Osteoarthritis
Mild Knee Osteoarthritis, Moderate Knee Osteoarthritis
Recruiting
Percutaneous Neurostimulation in Knee Osteoarthritis
Osteoarthritis (OA) of the Knee, Neuromodulation

All Moderate Pain in Knee Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-blind, Agent-positive and Placebo-controlled, Parallel-group Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis
ClinicalTrials.gov ID: NCT07351968
Acronym / sponsor ID: HRS-2129-106
Conditions: Moderate Pain in Knee Osteoarthritis, Severe Pain in Knee Osteoarthritis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 202 participants (actual)
Lead sponsor: Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
Study start: 10 Mar 2026 (actual)
Primary completion: 17 Jul 2026 (actual)
Study completion: 17 Jul 2026 (actual)
First posted: 20 Jan 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4
Model description: Comparison between HRS-2129 high dose group, HRS-2129 low dose group, Celecoxib positive control group, and Placebo control group.

Arm	Type	Receives
HRS-2129 High Dose Group	Experimental	Drug: HRS-2129 Tablet, Drug: Celecoxib Capsule Placebo, Drug: HRS-2129 Tablet PlaceboHRS-2129 high dose group.
HRS-2129 Low Dose Group	Experimental	Drug: HRS-2129 Tablet, Drug: Celecoxib Capsule Placebo, Drug: HRS-2129 Tablet PlaceboHRS-2129 low dose group.
Celecoxib Group	Active comparator	Drug: Celecoxib capsule, Drug: HRS-2129 Tablet PlaceboCelecoxib group.
Placebo Group	Placebo comparator	Drug: Celecoxib Capsule Placebo, Drug: HRS-2129 Tablet PlaceboPlacebo group.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Voluntarily sign the informed consent form before starting the activities related to the trial;
The Numerical Evaluation Scale (NRS) pain score of the index knee joint at screening is ≥ 4;
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 ;
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.

Key exclusion criteria (11 listed)

History of other diseases that may involve the target joint;
History of major trauma or surgery of knee joint and hip joint in the past year;
Plan to undergo surgical procedure during the study;
Most or complete loss of mobility;
There are other diseases that may confuse the assessment of osteoarthritis pain;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HRS-2129 TabletHRS-2129 tablet.	Drug	HRS-2129 High Dose Group, HRS-2129 Low Dose Group
Celecoxib capsuleCelecoxib capsule.	Drug	Celecoxib Group
Celecoxib Capsule PlaceboCelecoxib capsule placebo.	Drug	HRS-2129 High Dose Group, HRS-2129 Low Dose Group, Placebo Group
HRS-2129 Tablet PlaceboHRS-2129 tablet placebo.	Drug	Celecoxib Group, HRS-2129 High Dose Group, HRS-2129 Low Dose Group, Placebo Group

Primary outcome

Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale scores.
Time frame: At week 4.

10 secondary outcomes

Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale scores.
Time frame: From baseline to Week 1, 2 and 3.
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) joint function subscale scores.
Time frame: From baseline to Week 1, 2, 3 and 4.
Change from baseline in the weekly mean (Week 1, 2, 3 and 4) of the index Knee Numerical Rating Scale (NRS) pain score (resting).
Time frame: From baseline to Week 1, 2, 3 and 4.
Change from baseline in the weekly mean (Week 1, 2, 3 and 4) of the index Knee Numerical Rating Scale (NRS) pain score (flat walking).
Time frame: From baseline to Week 1, 2, 3 and 4.
Change from baseline in the overall patient global assessment (PGA) of osteoarthritis condition using the 5-point Likert scale.
Time frame: From baseline to Week 1, 2, 3 and 4.
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale scores.
Time frame: From baseline to Week 1, 2, 3 and 4.
Change from baseline in total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score.
Time frame: From baseline to Week 1, 2, 3 and 4.
Treatment response: WOMAC pain subscale scores decreased by ≥ 30%, ≥ 50%, ≥ 70% from baseline.
Time frame: At Week 1, 2, 3 and 4.
Adverse events (AEs) occurred during the study.
Time frame: During the study, approximately 8 months.
Serious adverse events (SAEs) occurred during the study.
Time frame: During the study, approximately 8 months.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
Individual participant dataSharing planned: Undecided

Related trials for Moderate Pain in Knee Osteoarthritis

RecruitingObservational study
Cartilage Biomarker Response to Acute Mechanical Loading in Women With Knee Osteoarthritis: Comparison by Antiresorptive Treatment Status
Knee Osteoarthritis
Recruiting
Patient Pain and Function in Medial Knee Osteoarthritis After Anteromedial vs Anterolateral Intra-Articular Corticosteroid Injection
Osteoarthitis, Osteoarthritic Knee Pain
Active, not recruiting
Effect of Autologous Ear Cartilage Micrografting in Knee Osteoarthritis
Osteoarthritis, Osteoarthritis (OA) of the Knee
Not yet recruiting
The Efficacy and Safety Study of 2107 Injection in Subjects With Mild to Moderate Knee Osteoarthritis
Mild Knee Osteoarthritis, Moderate Knee Osteoarthritis
Recruiting
Percutaneous Neurostimulation in Knee Osteoarthritis
Osteoarthritis (OA) of the Knee, Neuromodulation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale scores. (time frame: At week 4.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07351968.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.