A Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShandong Suncadia Medicine Co., Ltd.
About this trial
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; To evaluate the population pharmacokinetic profile of HRS-2129 in patients with knee osteoarthritis.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- HRS-2129 Tablet
- Celecoxib capsule
- Celecoxib Capsule Placebo
- HRS-2129 Tablet Placebo
Treatment groups
200 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov