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

Kyowa Kirin Co., Ltd.23 sites in 2 countries116 target enrollmentAugust 3, 2022

ConditionsHealthy Volunteers Systemic Lupus Erythematosus (SLE)Cutaneous Lupus Erythematosus (CLE)

InterventionsPlacebo KK4277

DrugsPlacebo KK4277

Overview

Phase: Phase 1
Intervention: Placebo
Conditions: Healthy Volunteers
Sponsor: Kyowa Kirin Co., Ltd.
Enrollment: 116
Locations: 23
Primary Endpoint: Number of participants with adverse events (AEs)
Status: Active, not recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

August 3, 2022

End Date

December 1, 2025

Last Updated

7 months ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Kyowa Kirin Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

•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

Arms & Interventions

Placebo

Intervention: Placebo

KK4277

Intervention: KK4277

Outcomes

Primary Outcomes

Number of participants with adverse events (AEs)

Time Frame: Part 1 : from Day 1 through at most Day 113, Part 2: from Day 1 through at most Day 169

For adverse events that occurred after administration of the investigational drug, number of subjects with AEs and occurrence frequency are evaluated.

Secondary Outcomes

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)