Healthy VolunteersPhase 1NCT05411016
A Study of KK4277 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus
A Phase 1 study testing KK4277 in people with Healthy Volunteers and Systemic Lupus Erythematosus (SLE), run by Kyowa Kirin Co., Ltd. at 23 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
- What is being tested?
- KK4277
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 23 sitesin 2 countries
- Study dates
- 3 Aug 2022to 27 Oct 2025
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
- 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
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
Japan21 sites
National University Corporation Tohoku University Tohoku University Hospital
Aoba, Miyagi, 980-8574
Institute of Science Tokyo Hospital
Bunkyō-Ku, Tokyo, 113-8519
Niigata University Medical & Dental Hospital
Chuo Ku, Niigata, 951-8520
St. Luke's International Hospital
Chuo Ku, Tokyo, 104-8560
Fukushima Medical University Hospital
Fukushima, 960-1295
University of the Ryukyus Hospital
Ginowan, Okinawa, 901-2725
Kyusyu University Hospital
Higashi, Fukuoka, 812-8582
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641
Fujita Health University Hospital
Kutsukake, Aichi-ken, 470-1192
Japan Community Health care Organization Chukyo Hospital
Minami, Aichi-ken, 457-8510
Yokohama City University Medical Center
Minami, Kanagawa, 232-0024
Kitasato University Hospital
Minami, Kanagawa, 252-0375
Saitama Medical University Hospital
Moriyama, Saitama, 350-0495
Nagasaki University Hospital
Nagasaki, 852-8501
Showa Medical University East Hospital
Shinagawa-Ku, Tokyo, 142-0054
Keio University Hospital
Shinjuku-Ku, Tokyo, 160-8582
Japan Institute for Health Security National Center for Global Health and Medicine
Shinjuku-Ku, Tokyo, 162-8655
Medical Co. LTA Sumida Hospital
Sumida-ku, Tokyo, 130-0004
Juntendo University Nerima Hospital
Tokyo, 177-8521
Juntendo University Urayasu Hospital
Urayasu, Chiba, 279-0021
Wakayama Medical University Hospital
Wakayama, 641-8510
South Korea2 sites
Seoul National University Hospital
Seoul, 03080
Ajou University Hospital
Suwon, Gyeonggi-do, 16499
About this study
Official title: 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
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).
- Conditions
- Healthy Volunteers, Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
- Being tested
- Placebo, KK4277
- Medical subject headings
- Lupus Erythematosus, Systemic, Lupus Erythematosus, Cutaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo is administered single dose or multiple dose by IV or SC injection
KK4277Drug
KK4277 is administered single dose or multiple dose by IV or SC injection
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| KK4277 | Experimental | Not described Receives: Drug: KK4277 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Part 1 : from Day 1 through at most Day 113, Part 2: from Day 1 through at most Day 169
Secondary outcomes (4)
Profile of pharmacokinetics of serum KK4277 concentration
Measured: 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
Measured: Part 1 : Day 1 to Day 113, Part 2 : Day 1 to Day 169
The maximum concentration
Measured: Part 1 : Day 1 to Day 113, Part 2 : Day 1 to Day 169
Area under the concentration-time curve
Measured: Part 1 : Day 1 to Day 113, Part 2 : Day 1 to Day 169
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start3 Aug 2022
- Primary completion10 Dec 2024
- Study completion27 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jun Kinoshita, Study chair, Kyowa Kirin Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05411016
- Sponsor's protocol ID
- 4277-001
- Status last verified
- Sep 2026
- First submitted
- 6 Jun 2022
- Last updated
- 29 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets generated and/or analyzed during the study sponsored by Kyowa Kirin will be available in the Vivli repository, https://vivli.org/ourmember/kyowa-kirin/ as long as conditions of data disclosure specified in the policy section of the Vivli website are satisfied.