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

Uremic Pruritus Clinical Trial

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

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04393675
Study type Interventional
Source Lumosa Therapeutics Co., Ltd.
Contact Claire Sun
Phone +886-2-2655-7918
Email claire_sun@lumosa.com.tw
Status Recruiting
Phase Phase 1/Phase 2
Start date May 14, 2020
Completion date March 31, 2022
View Details
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