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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05411016

Enrollment

157

Registered

2022-06-08

Start date

2022-08-03

Completion date

2025-12-31

Last updated

2025-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

Interventions

DRUGPlacebo

Placebo is administered single dose or multiple dose by IV or SC injection

DRUGKK4277

KK4277 is administered single dose or multiple dose by IV or SC injection

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Outcomes Assessor: pharmacokinetic person, pharmacodynamic analysis person and investigational drug administration person are unblinded.

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Number of participants with adverse events (AEs)	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

Measure	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

Countries

Japan, South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026