This is a Phase I, single-center trial to assess the safety, tolerability, PK and food effect of KR23343 in healthy volunteers. The study will be conducted in 3 sequential stages:
Stage 1: Single-Ascending-Dose (SAD) study A randomized, double-blind, placebo-controlled, dose-escalation study to assess the safety, tolerability, and PK of single ascending doses of KR23343.
Stage 2: Food-Effect (FE) study An open-label, randomized, two-period, two-sequence crossover study to evaluate the effect of food on the PK of a single dose of KR23343.
Stage 3: Multiple-Ascending-Dose (MAD) study A randomized, double-blind, placebo-controlled, dose-escalation study to investigate the safety, tolerability, and PK of repeated once-daily administration of KR23343 for 10 days.
Healthy male or female participants aged 18 to 45 years, inclusive.
Body mass index (BMI) between 19 and 28 kg/m² (inclusive) and body weight ≥ 50 kg for males or ≥45 kg for females.
All screening assessments (vital signs, physical examination, laboratory tests, ECG) must be within normal limits or deemed not clinically significant by the investigator. One repeat assessment is permitted during the screening period to confirm eligibility.
Participants must agree not to donate gametes (sperm or ova), must not be planning pregnancy, and must use a reliable contraceptive method from the time of informed consent signing through 3 months following the last dose.
Hypersensitivity or allergic to KR23343.
History of severe hypersensitivity reactions or multiple drug/food allergies
Significant disease affecting the central nervous, cardiovascular, gastrointestinal, respiratory, renal, hematologic, metabolic, or musculoskeletal systems, or any condition considered by the Investigator to make the participant unsuitable for the trial.
Any surgical or medical condition that may significantly affect drug absorption, distribution, metabolism, or excretion, or compromise participant safety, including but not limited to urinary tract obstruction, dysuria, gastroenteritis, peptic ulcer disease, or history of gastrointestinal bleeding.
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Treatment groupsSee each treatment group below.