About this trial
This study aims to investigate the efficacy and safety of HRS-2129 in Chinese diabetic peripheral neuropathic pain (DPNP) in comparison to placebo.
Eligibility criteria
Qualifiers
Able and willing to provide a written informed consent.
Males or females aged ≥18years of age inclusive.
Diagnosis of diabetic peripheral neuropathic pain (DPNP) and diabetic peripheral neuropathy (DPN) pain ≥ 3 months.
HbA1c ≤ 9.0% at screening and on a stable antidiabetic medication regimen for at least 30 days prior to screening as far as possible.
Disqualifiers
Subjects with a history of severe allergies.
Peripheral neuropathy or pain unrelated to diabetic peripheral neuropathy (DPN) that may confuse the assessment of diabetic peripheral neuropathic pain (DPNP).
Subjects with abnormal liver and renal function.
Corrected QT Interval (QTc): > 450 ms (male), > 470 ms (female).
Trial design
Treatments tested in this trial
- HRS-2129 Tablets
- HRS-2129 Placebo
- Pregabalin Capsules
- Pregabalin Capsules Placebo