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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Healthy Volunteers, Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)

Intervention / Treatment
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* Drug: Placebo
* Drug: KK4277


Participation Criteria
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Eligibility Criteria
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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 Patients who meet the EULAR/ACR 2019 SLE classification criteria and have a diagnosis of SLE by screening 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo is administered single dose or multiple dose by IV or SC injection<br>|
| Experimental: KK4277<br> | Drug: KK4277<br>* KK4277 is administered single dose or multiple dose by IV or SC injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events (AEs) | For adverse events that occurred after administration of the investigational drug, number of subjects with AEs and occurrence frequency are evaluated. | Part 1 : from Day 1 through at most Day 113, Part 2: from Day 1 through at most Day 169 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Profile of pharmacokinetics of serum KK4277 concentration |  | Part 1 : Day 1 (pre-dose, 0, 1, 6 hours after the start of administration), 2, 3, 4, 5, 6, 8, 15, 22, 29, 43, 57, 71, 85, 99, 113, Part 2 :Enrollment, Day1, 8, 15, 29, 43, 57, 71, 85, 99, 113, 141, 169 | 
| Time to the maximum concentration |  | Part 1 : Day 1 to Day 113, Part 2 : Day 1 to Day 169 | 
| The maximum concentration |  | Part 1 : Day 1 to Day 113, Part 2 : Day 1 to Day 169 | 
| Area under the concentration-time curve |  | Part 1 : Day 1 to Day 113, Part 2 : Day 1 to Day 169 |