The study is being conducted to evaluate the safety, and efficacy of HRS-2129 for acute gouty arthritis. To explore the reasonable dosage of HRS-2129 for acute gouty arthritis.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Able and willing to provide a written informed consent
2. Subjects requiring Acute gouty arthritis
3. Target joint VAS pain score ≥ 50 mm (screening)
Exclusion Criteria:
1. Subjects with a history of severe allergies
2. Subjects with nervous system disease
3. Subjects with a history of mental illness
4. Subjects with abnormal liver and renal function
5. Subjects with poorly controlled hypertensive
6. QTc：\>450ms（male），\>470ms（female）
7. History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
8. The investigators determined that other conditions were inappropriate for participation in this clinical trial
Primary outcome measure(s)
Change from baseline inVisual Analogous Scale pain score at 24 hours post first dose — from ICF signing date to 24 hours after first dose VAS，Visual Analogue Score is an often-used tool to measure subjective phenomena, which has shown good reliability and validity in terms of assessment of pain. In the clinical study of acute gout attack，it can be used as a tool to measure the degree of pain from 0 to 100 mm (with 0 being no pain and 100 being maximum pain)
Trial sites (2)
Facility
City
Region
Status
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou
Guangdong
Recruiting
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Nanjing
Jiangsu
Recruiting
More Shandong Suncadia Medicine Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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