A First-in-Human Study of KINE-101 in Healthy Volunteers

Inclusion Criteria: * Signed IRB-approved informed consent before any screening procedures. * Healthy subjects with no clinically significant illness or disease based on medical history, physical exam, ECG, and lab tests. * Males and females aged 18-55 years at screening. * Nonsmokers or no nicotine use for ≥1 year; urine cotinine \<200 ng/mL at screening and admission. * BMI 18.5-30.0 kg/m² and body weight ≥50 kg at screening. * Suitable veins for venipuncture/cannulation. * Able to fast overnight (≥10 hours). * Male subjects agree to use condoms during intercourse and for 1 month after last IMP dose. * Male subjects must not donate sperm from dosing day until 1 month after last IMP dose. * Female subjects must be of non-childbearing potential (postmenopausal ≥12 months with FSH \>40 IU/L or surgical sterilization such as hysterectomy, tubal ligation, bilateral oophorectomy/salpingectomy). Exclusion Criteria: * Received an investigational medicinal product (IMP) within 30 days or 5× half-life before first IMP administration. * History of alcohol abuse within 2 years, weekly intake \>21 units, or positive alcohol test at screening/admission. * Current smokers or nicotine use within 12 months; positive urine cotinine at screening/admission. * Clinically significant abnormal labs: ALT, AST, or total bilirubin \>ULN (or \>1.5×ULN if Gilbert's), serum creatinine \>ULN, eGFR \<80 mL/min/1.73 m², abnormal TSH, or other clinically relevant abnormal values. * Positive drug abuse test at screening or admission. * Positive HBsAg, anti-HCV, or HIV antibody at screening. * Clinically significant psychiatric, cardiovascular, renal, hepatic, or chronic respiratory disease, including arrhythmia. * Supine BP \<90 or \>140 mmHg systolic, or \<50 or \>90 mmHg diastolic after 5 minutes supine. * Supine pulse \<50 bpm or \>100 bpm after 5 minutes supine. * Personal or family history of long QTc syndrome, sudden cardiac death, or hERG mutation. * Severe adverse reaction or hypersensitivity to any drug or excipients. * Blood donation or loss \>400 mL within 3 months or hemoglobin below normal limits. * Use of prohibited medications, OTC drugs, herbal remedies, or supplements within 28 days before IMP administration. * Received live or attenuated vaccines or systemic corticosteroids within 3 months prior to first IMP dose. * Conditions interfering with drug absorption, distribution, metabolism, or excretion. * Employees of sponsor/CRO or close relatives involved in the study. * Unable to communicate meaningfully with study staff. * QTcF \>450 ms at screening or admission. * Significant liver impairment or abnormal conjugated/direct bilirubin \>ULN. * Consumption of methylxanthines (tea, coffee, chocolate), quinine-containing drinks, grapefruit, Seville oranges, poppy seeds, or alcohol within protocol-defined windows before IMP administration. * Investigator judges subject unfit for any reason. * Positive SARS-CoV-2 RT-PCR within 4 weeks prior to screening. * COVID-19 symptoms within 14 days prior to screening. * Severe COVID-19 history (e.g., ECMO, mechanical ventilation). * Unable to attend in-person visits per site COVID guidelines. * Scheduled to receive COVID-19 vaccination within 2 weeks before or after IMP administration.