A study of KK4277 in Healthy Volunteers, Patient with Systemic Lupus Erythematosus, and Patient with Cutaneous Lupus Erythematosus

JRCT ID: jRCT2071220015

Registered date:12/06/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus
• Date of first enrollment: 19/07/2022
• Target sample size: 158
• Study type: Interventional

Intervention(s)

<Part 1> A single IV or SC administration of KK4277
<Part 2> Repeated IV administration of KK4277

Outcome(s)

• Primary Outcome: Number of participants with adverse events

Secondary Outcome

-Profile of pharmacokinetics of serum KK4277 concentration
-Time to the maximum concentration
-The maximum concentration
-Area under the concentration-time curve

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 75age old
• Gender: Both

Include criteria

Part 1:
- Voluntary written informed consent to participate in the study
- Japanese or non-Asian healty men 18 to < 50 years at the time of informed consent
- BMI 18.5 to < 30.0 at screening

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

Exclude 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 Cacer.
- History or of current drug allergy

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 skin rashes (psoriasis, drug-induced lupus, sarcoidosis, etc.) that may affect safety and efficacy evaluation
-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

Related Information

• Primary Sponsor: Kinoshita Jun