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Phase 1 Study to Test the Safety and Effectiveness of HRS-2129 Compared to Placebo and Pregabalin in Chinese Adults With Diabetic Peripheral Neuropathic Pain
Led by Shandong Suncadia Medicine Co., Ltd. · Updated on 2026-04-15
168
Participants Needed
2
Research Sites
8 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of HRS-2129 in Chinese adults with diabetic peripheral neuropathic pain DPNP. This phase 1, multicenter, randomized, double-blind trial compares HRS-2129 to placebo and pregabalin capsules to better understand its effects on pain relief in patients with DPNP lasting at least three months. Participants may receive one of several study treatments high dose or low dose HRS-2129 tablets, pregabalin capsules, or placebos matching these drugs. The study includes a 4-week treatment period with assessments at baseline and Week 4. Blood samples will be collected to study the pharmacokinetics of HRS-2129. The trial uses a quadruple masking design to keep participants and researchers unaware of the assigned treatments. During the study, participants will report their average daily pain using scales such as the Average Daily Pain Score and Visual Analog Scale. Other measures include sleep interference, patient global impressions, and pain questionnaires. Safety is closely monitored by tracking adverse events over 6 weeks. The study began in March 2026 and is expected to complete by November 2026.
CONDITIONS
Brief Title
A Study of HRS-2129 in Patients With Diabetic Peripheral Neuropathic Pain
Research Team
L
Lei Tang
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