Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07351968
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07351968
Study Brief:
Protocol Section:
NCT07351968