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

NCT07324642 | Completed Phase 1

• 1 other identifier: CIDP101-CR1-002P
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Maximum plasma concentration (Cmax)

  From Day 1 (pre-dose) through Day 7 post-dose

• Area under the plasma concentration-time curve (AUC)

  From Day 1 (pre-dose) through Day 7 post-dose

• Terminal half life (t½)

  From Day 1 (pre-dose) through Day 7 post-dose

Other Outcomes (2)

• Change from baseline in serum biomarkers following KINE-101 administration

  From Day 1 to Day 35 (End of Study visit)

• Change from baseline in immunophenotyping markers following KINE-101 administration

  From Day 1 to Day 35 (End of Study visit)

Study Arms (2)

KINE-101

EXPERIMENTAL

Drug: KINE-101

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

KINE-101 DRUG

KINE-101 injection, 12.5 mg/mL, intravenous infusion once daily for 7 days under fasting conditions.

KINE-101

Placebo DRUG

0.9% sodium chloride, intravenous infusion once daily for 7 days under fasting conditions.

Placebo

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kine Sciences Co., Ltd.: lead
• Chungbuk National University Hospital: collaborator

Study Sites (1)

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, 28644, South Korea

Location

Study Officials

• Hanna Park

  Kine Sciences Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: January 7, 2026
• Study Start: May 26, 2025
• Primary Completion: August 25, 2025
• Study Completion: August 25, 2025
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)