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

Shandong Suncadia Medicine

Status and phase: Not yet enrolling; Phase 1

Conditions: Diabetic Peripheral Neuropathic Pain

Treatments: Drug: Pregabalin Capsules Placebo; Drug: HRS-2129 Tablets; Drug: HRS-2129 Placebo; Drug: Pregabalin Capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT07377721

HRS-2129-105

Details and patient eligibility

About

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

Enrollment: 168 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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168 participants in 4 patient groups, including a placebo group

HRS-2129 High Dose Group

Experimental group

Treatment:

Drug: HRS-2129 Placebo

Drug: HRS-2129 Tablets

Drug: Pregabalin Capsules Placebo

HRS-2129 Low Dose Group

Experimental group

Treatment:

Drug: HRS-2129 Placebo

Drug: HRS-2129 Tablets

Drug: Pregabalin Capsules Placebo

Pregabalin Group

Active Comparator group

Treatment:

Drug: Pregabalin Capsules

Drug: HRS-2129 Placebo

Blank Preparation Placebo Group

Placebo Comparator group

Treatment:

Drug: HRS-2129 Placebo

Drug: Pregabalin Capsules Placebo