Phase 1 Study of Topical YJ001 Spray to Evaluate Safety, Tolerability, and Effectiveness in Adults Aged 18 to 80 with Diabetic Peripheral Neuropathic Pain

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of a topical spray called YJ001 for patients with diabetic peripheral neuropathic pain DPNP. This Phase I, randomized, double-blind, placebo-controlled study includes adults aged 18 to 80 years and is conducted at a single study center. The study involves two dose levels and aims to assess multiple ascending doses applied topically to both feet and below the ankles. Participants are assigned to one of two cohorts receiving either 296 mg or 414 mg doses of YJ001, each cohort including 12 subjects with 10 receiving the active spray and 2 receiving placebo. The treatment is administered as multiple sprays on both feet once in the morning on Days 1 and 2, then twice daily morning and evening from Days 3 to 11. The Safety Review Committee evaluates safety and pharmacokinetics data after each cohort to decide on dose escalation or other study actions. Before starting treatment, subjects undergo screening and a baseline pain rating period from Day -7 to Day -1. They stay in the clinic from Day -1 through Day 17 for treatment and observation, with follow-up by phone 2 days after discharge. Researchers monitor safety through adverse events, laboratory tests, and skin reactions for about one year. Pharmacokinetics and efficacy are assessed through various measurements during and after dosing, ensuring detailed evaluation of the treatments effects and tolerability.

MAD Study to Assess the Safety, Tolerability, PKs and Efficacy of YJ001 for Spray Use in Patients With DPNP