NCT05411016

A Study of KK4277 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus

A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose or Multiple Ascending Dose Study of KK4277 in Healthy Volunteers, Patient With Systemic Lupus Erythematosus, and Patient With Cutaneous Lupus Erythematosus

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 157 (estimated)
• Sponsor: Kyowa Kirin Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Part 1 : To evaluate the safety and tolerability of a single intravenous (IV) or subcutaneous (SC) dose of KK4277 in healthy Japanese or non-Asian adult males. Part 2 : To evaluate the safety and tolerability of repeated IV or SC administration of KK4277 in patients with Systemic lupus erythematosus (SLE) or Cutaneous lupus erythematosus (CLE).

Conditions

• Healthy Volunteers
• Systemic Lupus Erythematosus (SLE)
• Cutaneous Lupus Erythematosus (CLE)

Interventions

Type	Name	Description
DRUG	Placebo	Placebo is administered single dose or multiple dose by IV or SC injection
DRUG	KK4277	KK4277 is administered single dose or multiple dose by IV or SC injection

Timeline

• Start date: 2022-08-03
• Primary completion: 2024-12-10
• Completion: 2025-12-01
• First posted: 2022-06-08
• Last updated: 2025-09-19

Locations

23 sites across 2 countries: Japan, South Korea