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CIDP - Chronic Inflammatory Demyelinating PolyneuropathyPhase 1NCT07343310

A First-in-Patient Clinical Trial of KINE-101 in Patients With Corticosteroid-Refractory CIDP

A Phase 1 study testing KINE-101 in people with CIDP - Chronic Inflammatory Demyelinating Polyneuropathy, run by Kine Sciences Co., Ltd. at 2 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a multicenter, open-label, single-dose, dose-escalation study evaluating the safety and tolerability of intravenous (IV) KINE-101 in patients with corticosteroid-refractory chronic inflammatory demyelinating polyneuropathy (CIDP). Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
KINE-101
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
2 sitesSouth Korea
Study dates
27 Aug 2024to 14 Apr 2025
Phase
Phase 1
Are there results?
None posted in the registry

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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults aged ≥19 years at informed consent.
  • Diagnosed with CIDP and refractory to corticosteroid treatment for ≥3 months prior to enrollment, or corticosteroid treatment deemed inappropriate or cannot be continued for safety reasons.
  • Meets EAN/PNS 2021 criteria for typical CIDP:
  • Progressive or relapsing symmetrical motor weakness in arms and legs with sensory involvement in ≥2 limbs
  • Symptom duration ≥8 weeks
  • Reduced or absent tendon reflexes in all extremities
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  • INCAT disability score ≥2 at screening (score of 2 must result solely from leg disability).
  • CIDP Disease Activity Status (CDAS) score ≥3 at screening.
  • Received IVIg ≥2 months prior to IP administration.
  • If the subject is of childbearing potential, agrees to use highly effective contraception for ≥28 days after IP administration.
  • Adequate venous access for IV administration and blood sampling.
  • Willing and able to comply with all study procedures.

Who cannot join

  • Polyneuropathy due to other causes (e.g., MMN, MGUS with anti-MAG antibodies, hereditary neuropathies, POEMS syndrome, diabetic or systemic disease-related neuropathy, drug/toxin-induced neuropathy).
  • History of myelopathy or confirmed central demyelination.
  • Known allergy or hypersensitivity to the investigational product or its excipients.
  • Uncontrolled severe hepatic disease, CNS disorders, alcoholism, substance abuse, or psychiatric disorders.
  • Other medical conditions that better explain symptoms (e.g., stroke, CNS trauma, connective tissue disease).
  • Malignancy within 5 years, except adequately treated low-risk cancers.
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  • Moderate to severe heart failure or severe cardiovascular disease (e.g., MI, ischemic stroke).
  • Moderate to severe substance or alcohol use disorder within 1 year.
  • Positive pregnancy test or planning pregnancy, breastfeeding, or gamete donation within 28 days post-IP.
  • Use of systemic immunosuppressants or immunostimulants within 5 half-lives prior to IP administration.
  • Plasma exchange within 8 weeks prior to IP administration.
  • Chronic infections or expected need for anti-infective treatment during the study.
  • Active hepatitis B or C infection or HIV positive.
  • Abnormal labs at screening: AST/ALT >3×ULN, Hb <9 g/dL, ANC <1,500/μL, Platelets <100×10³/μL.
  • Major surgery within 3 months or planned during study participation.
  • Investigator deems subject unsuitable for any reason.

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

  • Kangbuk Samsung Hospital

    Seoul, Seoul, 03181

  • Samsung Medical Center

    Seoul, Seoul, 06351

Other trials in South Korea

About this study

Official title: Multi-Center, Open-label, Single Dosing, Dose-Ascending, Phase 1 Study to Evaluate the Safety and Tolerability of KINE-101 in Patients With CIDP (Chronic Inflammatory Demyelinating Polyneuropathy) Refractory to Corticosteroid Treatment

This is a multicenter, open-label, single-dose, dose-escalation study evaluating the safety and tolerability of intravenous (IV) KINE-101 in patients with corticosteroid-refractory chronic inflammatory demyelinating polyneuropathy (CIDP). On Day 1, subjects receive a single IV dose of KINE-101 at the assigned cohort level and are discharged on Day 3, approximately 48 hours after investigational product (IP) administration, once all required in-clinic assessments have been completed. Safety assessments (including dose-limiting toxicities [DLTs], adverse events, clinical laboratory tests, vital signs, physical examinations, and 12-lead ECGs), exploratory efficacy evaluations, and PK/PD assessments are conducted through Day 28 in accordance with the schedule of assessments.

Exploratory efficacy assessments through Day 28 include changes from baseline in the following clinical measures: Inflammatory Neuropathy Cause and Treatment (INCAT) disability score, Medical Research Council (MRC) total sum score, Inflammatory Rasch-Built Overall Disability Scale (I-RODS), Timed Up-and-Go (TUG) test, mean grip strength, and the Overall Neuropathy Limitations Scale (ONLS).

Read more

Pharmacodynamic (PD) assessments include immunophenotyping of CD4+ T-cell subsets (CD4, CD25, FOXP3, CD39, CD69, CTLA-4, LAG-3, TNFR2, TIGIT, CCR5, and CXCR3); measurement of serum cytokines and immunoglobulins (IgM, IgG, IL-2, IL-6, IL-10, IL-17, IFN-γ, MCP-1, and TGF-β); evaluation of autoantibody and complement markers (antinuclear antibodies, anti-SM, anti-RNP, anti-SSA, anti-double-stranded DNA antibodies, and complement C4); and additional laboratory parameters related to systemic inflammation.

Dose escalation follows a standard 3+3 design based on review of safety, including DLTs, in the preceding cohort. Three KINE-101 dose cohorts are planned: Cohort 1 (120 mg), Cohort 2 (240 mg), and Cohort 3 (360 mg). If safety and tolerability are deemed acceptable in a given cohort, enrollment proceeds sequentially to the next higher dose level.

Being tested
KINE-101
Medical subject headings
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KINE-101Drug

    KINE-101 injection, 12.5 mg/mL, administered once intravenously on Day 1.

Study groups in NCT07343310
Study groupRoleWhat they receive
KINE-101 120mgExperimentalSubjects received a single intravenous dose of KINE-101 120 mg.
Receives: Drug: KINE-101
KINE-101 240 mgExperimentalSubjects received a single intravenous dose of KINE-101 240 mg.
Receives: Drug: KINE-101
KINE-101 360 mgExperimentalSubjects received a single intravenous dose of KINE-101 360 mg.
Receives: Drug: KINE-101

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Adverse Events (AEs)

    Incidence, severity, and relationship of treatment-emergent adverse events following a single intravenous dose of KINE-101.

    Measured: Day 1 to Day 28

  2. Number of Participants with Clinically Significant Abnormal Hematology

    Count of participants with clinically significant abnormal hematology findings (e.g., white blood cell count, hemoglobin, platelets, absolute neutrophil count), as defined per protocol.

    Measured: Day 1 to Day 28

  3. Number of Participants with Clinically Significant Abnormal Clinical Chemistry

    Count of participants with clinically significant abnormal clinical chemistry findings (e.g., ALT, AST, creatinine), as defined per protocol.

    Measured: Day 1 to Day 28

  4. Number of Participants with Clinically Significant Abnormal Urinalysis

    Count of participants with clinically significant abnormal urinalysis findings (e.g., protein/albumin, glucose, pH), as defined per protocol.

    Measured: Day 1 to Day 28

  5. Number of Participants with Clinically Significant Abnormal Vital Signs

    Count of participants with clinically significant abnormal vital sign findings (e.g., systolic or diastolic blood pressure, pulse rate, body temperature, respiratory rate), as defined per protocol.

    Measured: Day 1 to Day 28

  6. Number of Participants with Clinically Significant Abnormal Physical Examination

    Count of participants with clinically significant abnormal physical examination findings, as defined per protocol.

    Measured: Day 1 to Day 28

  7. Number of Participants with Clinically Significant Abnormal Electrocardiogram

    Count of participants with clinically significant abnormal electrocardiogram findings (e.g., PR interval, QRS duration, QT interval), as defined per protocol.

    Measured: Day 1 to Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2026
  2. Study start27 Aug 2024
  3. Primary completion14 Apr 2025
  4. Study completion14 Apr 2025

Resources

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
Non-randomised
Intervention model
Sequential
Model description
Sequential dose escalation in single experimental arm with cohorts receiving 120 mg, 240 mg, or 360 mg.
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07343310
Sponsor's protocol ID
CIDP101-CR1-001P
Status last verified
Jan 2026
First submitted
10 Dec 2025
Last updated
20 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing KINE-101 in people with CIDP - Chronic Inflammatory Demyelinating Polyneuropathy, run by Kine Sciences Co., Ltd. at 2 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events (AEs) (time frame: Day 1 to Day 28). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07343310.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.

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