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.