Study of Single and Multiple Ascending Doses of KR23343 in Healthy Adult Participants
ConditionHealthy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorJiangxi Kvvit Pharmaceutical Co., Ltd.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
KR23343
DrugParticipants will receive oral administrations of KR23343
Matching Placebo
DrugParticipants will receive placebo
Treatment groups
92 Participants
are divided into 12 treatment groups12
Treatment groupsSee each treatment group below.
Group A: Stage 1 Dose 1Experimental treatment 1 intervention
Group B: Stage 1 Dose 2Experimental treatment 1 intervention
Group C: Stage 1 Dose 3Experimental treatment 1 intervention
Group D: Stage 1 Dose 4Experimental treatment 1 intervention
Group E: Stage 1 Dose 5Experimental treatment 1 intervention
Group F: Stage 1 placeboPlacebo comparator 1 intervention
Group G: Stage 2 30 mg KR23343 Fed stateExperimental treatment 1 intervention
Group H: Stage 2 30 mg KR23343 Fasted stateExperimental treatment 1 intervention
Group I: Stage 3 Dose 1Experimental treatment 1 intervention
Group J: Stage 3 Dose 2Experimental treatment 1 intervention
Group K: Stage 3 Dose 3Experimental treatment 1 intervention
Group L: Stage 3 placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants With Treatment-Emergent Adverse Events, Serious Adverse Event(s) (SAEs), And Adverse Events Leading To Study Discontinuation
The number of participants with recorded treatment emergent adverse events, SAEs, and adverse events leading to study discontinuation following single and multiple doses of KR23343
Time frame
7 days in stage 1；21 days in stage 2; 16 days in stage 3.2
Number of participants with abnormal laboratory test results, abnormal vital signs, abnormal physical examination findings, and abnormal ECG parameters
Hematology, urinalysis, clinical chemistry, coagulation studies, vital signs (tympanic temperature, pulse, sitting blood pressure), and 12-lead ECGs (including heart rate, PR, RR, QRS, QT intervals, and QTcF) will be assessed at screening, pre-dose，and at post-dose timepoints as specified in the study
Time frame
7 days in stage 1；21 days in stage 2; 16 days in stage 3.Secondary outcomes
1
Peak Plasma Concentration (Cmax) of Stage 1
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of KR23343.
Time frame
Day 1 up to 144 hours post-dose2
Area Under the Plasma Concentration Versus Time Curve (AUC) of Stage 1
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of KR23343.
Time frame
Day 1 up to 144 hours post-dose3
Time to Cmax (Tmax) of Stage 1
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of KR23343.
Time frame
Day 1 up to 144 hours post-dose4
Elimination Half-life（t1/2）of Stage1
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of KR23343.
Time frame
Day 1 up to 144 hours post-doseSponsors and contacts
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Source ClinicalTrials.gov