Phase I Study of Single/Multiple Ascending Doses of JKN2501 for Injection in Chinese Healthy Volunteers

Inclusion criteria

• Voluntary informed consent; able to comply with study requirements and communicate effectively.
• Healthy subjects aged 18-45 years (inclusive) at screening.
• BMI 19.0-26.0 kg/m² (inclusive); weight ≥50 kg (male) or ≥45 kg (female).
• Vital signs, physical examination, ECG, laboratory tests, chest X-ray, and abdominal ultrasound results judged as normal or clinically insignificant by the investigator.
• Agreement to use effective non-pharmaceutical contraception from signing ICF until 90 days after last dose; no sperm/egg donation plans during this period.

Exclusion criteria

• Pregnant/lactating women; positive pregnancy test; unprotected sex within 2 weeks prior to dosing.
• Investigator-determined history or presence of clinically significant disorder that may affect safety or trial participation.
• Use of drugs known to inhibit/induce hepatic metabolism within 4 weeks, or any medication (prescription, OTC, herbal, vitamins) within 2 weeks prior to dosing; planned use during the trial.
• Major surgery within 3 months prior to screening or planned during trial; history of surgery potentially affecting results.
• History of febrile illness or active infection within 2 weeks prior to screening.
• Blood loss/donation >400 mL within 3 months prior to screening, or received blood products; plans to donate blood during trial or within 30 days after last dose.
• History of significant food/drug allergy, or allergy to JKN2501/excipients.
• Excessive alcohol consumption; inability to abstain from alcohol from 48h pre-dose until end of study.
• Smoking ≥5 cigarettes/day within 3 months prior to screening; inability to abstain from smoking from 48h pre-dose until end of study.
• History of drug abuse; positive urine drug screen at baseline (Day -1).
• Positive alcohol breath test at baseline (Day -1).
• Participation in another interventional clinical trial within 3 months prior to screening or planned during this trial.
• Estimated glomerular filtration rate (eGFR) <90 mL/min.
• Serum total calcium below lower limit of normal at screening.
• Investigator-determined unsuitable venous access for PK sampling/infusion, or history of adverse symptoms/phobias related to infusion/phlebotomy.
• Excessive daily intake of tea, coffee, or caffeinated beverages within 3 months prior to screening.
• Consumption of grapefruit, Seville oranges, caffeine, or xanthine-rich foods/beverages within 48h prior to first dose; inability to abstain during the trial.
• History of QTc prolongation; or investigator-determined clinically significant ECG abnormalities at screening/baseline.
• Any other condition deemed by the investigator to make the subject unsuitable for participation.