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Completed

NCT Number: NCT07324642

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

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Key information

Conditions

Healthy Volunteers

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chungbuk National University Hospital

Cheongju-si, North Chungcheong, 28644, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KINE-101

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events

    Time frame: From Day 1 to Day 35 (End of Study visit)

    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.

Secondary outcomes

  1. Maximum plasma concentration (Cmax)

    Time frame: From Day 1 (pre-dose) through Day 7 post-dose

    Maximum plasma concentration (Cmax) of KINE-101 following single and multiple doses.

  2. Area under the plasma concentration-time curve (AUC)

    Time frame: From Day 1 (pre-dose) through Day 7 post-dose

    Area under the plasma concentration-time curve (AUC) of KINE-101 following single and multiple doses.

  3. Terminal half life (t½)

    Time frame: From Day 1 (pre-dose) through Day 7 post-dose

    Terminal half life (t½) of KINE-101 following single and multiple doses.

Other outcomes

  1. Change from baseline in serum biomarkers following KINE-101 administration

    Time frame: From Day 1 to Day 35 (End of Study visit)

    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.

  2. Change from baseline in immunophenotyping markers following KINE-101 administration

    Time frame: From Day 1 to Day 35 (End of Study visit)

    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.

Sponsors and collaborators

Lead sponsor

Kine Sciences Co., Ltd.

Industry

Collaborators

  • Chungbuk National University Hospital

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 7, 2026
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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