A Phase 1 MAD Study of KINE-101 in Healthy Volunteers

A Randomized, Single-center, Single-blind, Placebo-controlled, Dose Escalation Phase 1 Clinical Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Characteristics of Multiple Intravenous Infusions of KINE-101 in Healthy Adult Volunteers

This is a randomized, single-center, single-blind, placebo-controlled, dose-escalation Phase 1 clinical trial designed to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic characteristics of multiple intravenous (IV) infusions of KINE-101 in healthy adult volunteers.

The study includes three sequential cohorts with a total of 24 subjects (8 subjects per cohort; 6 assigned to KINE-101 and 2 to placebo). Subjects in the treatment groups receive KINE-101 once daily for 7 consecutive days at doses corresponding to their assigned cohort (Cohort 1: 120 mg, Cohort 2: 240 mg, Cohort 3: 360 mg). Subjects in the placebo group receive 0.9% saline under identical conditions. All subjects are admitted on Day -1, receive daily dosing from Day 1 through Day 7, and are discharged on Day 9 after completion of safety monitoring. Follow-up visits are conducted on Days 14, 21, 28, and 35. Dose escalation proceeds sequentially from the lowest-dose cohort (Cohort 1) to the highest-dose cohort (Cohort 3). Safety and tolerability data collected through Day 35 in each preceding cohort are reviewed before initiating dosing in the next higher-dose cohort.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: KINE-101; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• South Korea
  • North Chungcheong
    • Cheongju-si, North Chungcheong, South Korea, 28644
      • Chungbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy male or female adults aged 19 to 55 years
• Body weight ≥ 50.0 kg and Body Mass Index (BMI) between 18.5 and 30.0 kg/m²
• Clinically healthy with no congenital or chronic diseases requiring treatment
• Normal findings in physical examination, vital signs, 12-lead ECG, and clinical laboratory tests at screening
• Provided written informed consent and willing to comply with all study restrictions and procedures

Exclusion Criteria:

• History or presence of clinically significant hepatic, renal, cardiovascular, respiratory, neurological, hematologic, endocrine, psychiatric, or malignant diseases
• Abnormal ECG findings (QTc > 450 ms for males or > 470 ms for females; PR > 200 ms; QRS > 120 ms)
• Abnormal liver or renal function (AST, ALT, ALP, γ-GT, or total bilirubin > 2× ULN; eGFR < 60 mL/min/1.73 m²)
• Positive drug abuse test or history of substance abuse
• Abnormal vital signs at screening (SBP ≤ 90 or ≥ 150 mmHg; DBP ≤ 60 or ≥ 100 mmHg; pulse ≤ 40 or ≥ 100 bpm)
• Vaccination with live or attenuated vaccines or systemic corticosteroid use within 3 months before dosing
• Use of enzyme-inducing/inhibiting drugs, herbal medicines, or other investigational products within 1-3 months before dosing
• Donation or transfusion of blood within 3 months before dosing
• Regular alcohol consumption > 21 units/week, or inability to abstain during the study
• Current smokers (> 10 cigarettes/day) or inability to refrain from smoking during study participation
• Intake of alcohol, grapefruit, quinine, Seville orange, or caffeine-containing products within 24-72 hours before dosing and during sampling periods
• Engagement in strenuous exercise within 48 hours before dosing
• Pregnant or breastfeeding women, or men and women not using reliable contraception
• Recent COVID-19 or influenza infection or vaccination within 2 weeks before dosing
• Difficult venous access or positive alcohol breath test
• Any other condition that, in the investigator's judgment, would make the subject unsuitable for participation in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; 0.9% sodium chloride, intravenous infusion once daily for 7 days under fasting conditions.
Experimental: KINE-101	Drug: KINE-101; KINE-101 injection, 12.5 mg/mL, intravenous infusion once daily for 7 days under fasting conditions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events	Number and percentage of subjects experiencing any treatment-emergent adverse event (TEAE) following multiple intravenous administrations of KINE-101 or placebo. Safety assessments will also include concomitant medications, physical examinations, local injection site reactions, and vital signs.	From Day 1 to Day 35 (End of Study visit)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum plasma concentration (Cmax)	Maximum plasma concentration (Cmax) of KINE-101 following single and multiple doses.	From Day 1 (pre-dose) through Day 7 post-dose
Area under the plasma concentration-time curve (AUC)	Area under the plasma concentration-time curve (AUC) of KINE-101 following single and multiple doses.	From Day 1 (pre-dose) through Day 7 post-dose
Terminal half life (t½)	Terminal half life (t½) of KINE-101 following single and multiple doses.	From Day 1 (pre-dose) through Day 7 post-dose

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in serum biomarkers following KINE-101 administration	The change from baseline in serum biomarkers following intravenous administration of KINE-101 including IgG, IgM, IL-2, IL-6, IL-10, IL-17, IFN-gamma, MCP-1, and TGF-beta.	From Day 1 to Day 35 (End of Study visit)
Change from baseline in immunophenotyping markers following KINE-101 administration	The change from baseline in immunophenotyping markers following intravenous administration of KINE-101 including CD4, CD25, FoxP3, CD39, CD69, LAG-3, CTLA-4, TNFR2, TIGIT, CCR5, and CXCR3.	From Day 1 to Day 35 (End of Study visit)

Collaborators and Investigators

• Sponsor: Kine Sciences Co., Ltd.
• Collaborators: Chungbuk National University Hospital
• Investigators: Study Director: Hanna Park, Kine Sciences Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2025
• Primary Completion (Actual): August 25, 2025
• Study Completion (Actual): August 25, 2025

Study Registration Dates

• First Submitted: December 9, 2025
• First Submitted That Met QC Criteria: December 24, 2025
• First Posted (Actual): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: December 24, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: CIDP101-CR1-002P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No