Clinical Study of HRS-2129 for Acute Gouty Arthritis

NCT07706777 | Not Yet Recruiting Phase 2

• 1 other identifier: HRS-2129-207
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Acute Gouty Arthritis

Outcome Measures

Primary Outcomes (1)

• Change from baseline inVisual Analogous Scale pain score at 24 hours post 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)

  from ICF signing date to 24 hours after first dose

Secondary Outcomes (4)

• Change from baseline in VAS pain score at 1 hour, 2 hours, 6 hours, 12 hours, 18 hours, 24 hours, 48 hours, 72 hours post first dose

  from ICF signing date to 1 hour, 2 hours, 6 hours, 12 hours, 18 hours, 24 hours, 48 hours, 72 hours after first dose

• Time until complete disappearance of pain in the target joint

  from ICF signing date to 15 days after first dose

• Mean daily VAS pain score change from baseline (on-treatment)

  from ICF signing date to 15 days after first dose

• Safety：Incidence and severity of AE/SAE

  from ICF signing date to day 14 after last dose(14 days)

Study Arms (3)

Treatment group A: HRS-2129 Tablet

EXPERIMENTAL

Drug: HRS-2129 Tablet

Treatment group B: HRS-2129 Tablet

EXPERIMENTAL

Drug: HRS-2129 Tablet

Treatment group C: HRS-2129 Tablet Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

HRS-2129 Tablet DRUG

HRS-2129 Tablet; high dose

Treatment group A: HRS-2129 Tablet

Placebo DRUG

HRS-2129 Tablet Placebo

Treatment group C: HRS-2129 Tablet Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide a written informed consent
• Subjects requiring Acute gouty arthritis
• Target joint VAS pain score ≥ 50 mm (screening)

You may not qualify if:

• Subjects with a history of severe allergies
• Subjects with nervous system disease
• Subjects with a history of mental illness
• Subjects with abnormal liver and renal function
• Subjects with poorly controlled hypertensive
• QTc：\>450ms（male），\>470ms（female）
• History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
• The investigators determined that other conditions were inappropriate for participation in this clinical trial

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Study Sites (2)

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

Location

Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

Location

Central Study Contacts

Lei Tang

CONTACT

+0518-82342973; lei.tang.lt31@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 16, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 16, 2026

Record last verified: 2026-07

Locations

CN (2)