This is a multi-center, randomized, double-blind, placebo-controlled study design evaluating the safety, efficacy, and PK parameter of HL-1186 tablet for diabetic peripheral neuropathic pain.
Aged between 18 and 75 years old (inclusive), regardless of gender.
With Type 1 or Type 2 diabetes mellitus, with a diagnosis of DPNP for at least 6 months.
Screening period: ADPS ranging from 4 to 9 points, and Visual Analog Scale (VAS) scores of 40mm - 90mm in two different days.
The hypoglycemic regimen has been stable for at least 4 weeks before enrollment, and the glycated hemoglobin (HbA1c) during the screening period is ≤ 9%.
Participants with any pain other than DPNP, or with other diseases that the investigator deems may affect the evaluation of DPNP.
Participants who are allergic to the active ingredients or excipients of HL-1186, HL-1186 placebo, or paracetamol tablets, or who have an allergic constitution, or have a history of allergies to ≥ 3 substances.
Participants who have used drugs that may damage nerves (such as tumor chemotherapy drugs) after being diagnosed with DPNP.
Participants who used any prohibited drugs within 2 weeks before screening (or within 5 half-lives after the last use of such prohibited drugs at the time of screening, whichever is longer).
Parallel
HL-1186
DrugHL-1186 tablet for oral administration.
HL-1186
DrugHL-1186 tablet for oral administration.
HL-1186 placebo
DrugHL-1186 placebo tablet for oral administration.
Change in average daily pain score (ADPS) from baseline after 12 weeks of administration
Change from baseline in the weekly mean of the daily Numeric Pain Rating Scale (NPRS) score assessing the worst pain intensity in the last 24 hours. Pain intensity was recorded on 11-point NPRS, score range: 0 to 10, where 0= no pain and 10= worst imaginable pain.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
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