NCT04393675

Study to Investigate the Safety of LT5001 Drug Product for Uremic Pruritus in Hemodialysis Patients

Clinical Pharmacology of LT5001 Drug Product in Hemodialysis Patients With Uremic Pruritus to Assess the Safety, Local Tolerance and Pharmacokinetics

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Lumosa Therapeutics Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Randomized, Double Blind, Placebo-Controlled study to assess the Safety, Local Tolerance, and Pharmacokinetics of LT5001 drug product in Hemodialysis Patients with Uremic Pruritus

Detailed description

In Part A, patient participation is expected to last up to 63 days, including a 28-day screening period(consisting of a 7-day diary run-in to build baseline itch NRS) and a 36-day on study period (consisting of 56 total doses from Day 1 to Day 29, and a 7 day follow-up/EOS visit at Day 36). In Part B, patient participation is expected to last up to 85 days, including a 28-day screening period (consisting of a 7-day diary run-in to build baseline itch NRS) and a 57-day on study treatment period.

Conditions

• Uremic Pruritus

Interventions

Type	Name	Description
DRUG	LT5001	LT5001 is administered twice daily.
DRUG	Placebo	LT5001 is administered twice daily.

Timeline

• Start date: 2020-05-14
• Primary completion: 2022-09-15
• Completion: 2022-09-15
• First posted: 2020-05-19
• Last updated: 2026-02-10
• Results posted: 2026-02-10

Locations

1 site across 1 country: Taiwan