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

Kine Sciences Co., Ltd.

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Placebo

Drug: KINE-101

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT07324642

CIDP101-CR1-002P

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

19 to 55 years old

Volunteers

Accepts Healthy Volunteers

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