This Phase I study is a randomized, double-blind, placebo-controlled, dose-escalation trial conducted at a single center. It consists of two parts:
Part 1 (SAD): Evaluates the safety, tolerability, and pharmacokinetics (PK) of single ascending intravenous doses of JKN2501 in healthy adults. Biological samples (blood, urine, feces) will be collected for PK analysis.
Part 2 (MAD): Evaluates the safety, tolerability, and PK of multiple ascending intravenous doses of JKN2501 in healthy adults.
Dose levels may be adjusted based on emerging safety, tolerability, and PK data from preceding cohorts.
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.
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.
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Treatment groupsSee each treatment group below.