A Study of HRS-2129 in Patients With Diabetic Peripheral Neuropathic Pain

A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Pregabalin Capsule Controlled, Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Chinese Patients With Diabetic Peripheral Neuropathic Pain

This study aims to investigate the efficacy and safety of HRS-2129 in Chinese diabetic peripheral neuropathic pain (DPNP) in comparison to placebo.

Inclusion Criteria:

1. Able and willing to provide a written informed consent.
2. Males or females aged ≥18years of age inclusive.
3. Diagnosis of diabetic peripheral neuropathic pain (DPNP) and diabetic peripheral neuropathy (DPN) pain ≥ 3 months.
4. HbA1c ≤ 9.0% at screening and on a stable antidiabetic medication regimen for at least 30 days prior to screening as far as possible.
5. At Screening, pain scale (Visual Analog Scale, VAS) of ≥ 40 mm and < 90 mm.

Exclusion Criteria:

1. Subjects with a history of severe allergies.
2. Peripheral neuropathy or pain unrelated to diabetic peripheral neuropathy (DPN) that may confuse the assessment of diabetic peripheral neuropathic pain (DPNP).
3. Subjects with abnormal liver and renal function.
4. Corrected QT Interval (QTc): > 450 ms (male), > 470 ms (female).
5. Failure to response to previous treatment with pregabalin at doses ≥ 300 mg/d or gabapentin at doses ≥ 1200 mg/d for treatment of diabetic peripheral neuropathic pain (DPNP).
6. History of suicidal behavior or attempted suicide.
7. Participated in another clinical study within 3 months prior to screening.