Healthy Volunteers
Conditions
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.
Interventions
DRUGKINE-101
KINE-101 injection, 12.5 mg/mL, intravenous infusion once daily for 7 days under fasting conditions.
DRUGPlacebo
0.9% sodium chloride, intravenous infusion once daily for 7 days under fasting conditions.
Sponsors
Chungbuk National University Hospital
Kine Sciences Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | 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
| Measure | Time frame | Description |
|---|---|---|
| Maximum plasma concentration (Cmax) | From Day 1 (pre-dose) through Day 7 post-dose | Maximum plasma concentration (Cmax) of KINE-101 following single and multiple doses. |
| Area under the plasma concentration-time curve (AUC) | 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. |
| Terminal half life (t½) | From Day 1 (pre-dose) through Day 7 post-dose | Terminal half life (t½) of KINE-101 following single and multiple doses. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in serum biomarkers following KINE-101 administration | 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. |
| Change from baseline in immunophenotyping markers following KINE-101 administration | 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. |
Countries
South Korea
Outcome results
None listed