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

• Status: Not yet recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

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 administration of KK4277 in patients with Systemic lupus erythematosus (SLE) or Cutaneous lupus erythematosus (CLE).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Kyowa Kirin Co., Ltd.

Criteria

Inclusion Criteria: Part 1

• Voluntary written informed consent to participate in the study

• Japanese or non-Asian healthy men 18 to < 50 years at the time of informed consent

• BMI 18.5 to < 30.0 at screening

Inclusion Criteria: Part 2

• Voluntary written informed consent to participate in the study

• Age 18 years to < 75 years at the time of informed consent

• Weight over 40 kg and BMI 18.5 to < 35.0 at screening

• Patients who meet any of the following criteria

1. Patients who meet the EULAR/ACR 2019 SLE classification criteria and have a diagnosis of SLE by screening

2. Patients with CLE diagnosed by skin biopsy

Exclusion Criteria: Part 1

• Current illness requiring treatment

• History of or current respiratory disease, heart disease, gastrointestinal disease, kidney disease, liver disease, psychiatric disease, autoimmune disease, or Cancer.

• History or of current drug allergy

Exclusion Criteria:Part2

• Complications of active lupus nephritis(urinary column (granular column or red blood cell column), hematuria (>5 red blood cells/high power field, excluding other causes such as stones or infection), proteinuria >0.5 g/24 h, pyuria (>5 white blood cells/high power field excluding infection)) or active central nervous lupus (delirium, psychiatric symptoms, seizures, etc.)

• Patients with serious complications that are judged by the investigator or sub-investigator to affect the conduct and evaluation of the study.

• Patients with bacterial, viral, fungal, or parasitic infections recognized within 28 days prior to obtaining consent

• Patients with an infectious disease requiring hospitalization or IV administration of antimicrobial, antiviral, antifungal, or antiparasitic drugs within 24 weeks prior to obtaining consent