NCT03846466

Study of KHK 4323 in Healthy Volunteers and Subjects With Atopic Dermatitis

A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Single Dose or Multiple Dose Study of KHK4323 in Healthy Volunteers, and Subjects With Atopic Dermatitis

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Kyowa Kirin Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Part 1: To investigate the safety and tolerability of intravenous (IV) or subcutaneous (SC) administration of a single dose of KHK4323 to Japanese or Caucasian healthy adult males in a double-blind, placebo-controlled study. Part 2: To investigate the safety and tolerability of intravenous (IV) administration of repeated doses of KHK4323 to atopic dermatitis patients in a double-blind, placebo-controlled study.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	KHK4323 IV/S	IV / Single administration
DRUG	KHK4323 SC/S	SC / Single administration
DRUG	KHK4323 IV/M	IV / Multiple administration
DRUG	Placebo IV/S	IV / Single administration
DRUG	Placebo IV/M	IV / Multiple administration
DRUG	Placebo SC/S	SC / Single administration

Timeline

• Start date: 2019-02-22
• Primary completion: 2019-12-11
• Completion: 2019-12-11
• First posted: 2019-02-19
• Last updated: 2020-01-28

Locations

1 site across 1 country: Japan