Study of Single and Multiple Ascending Doses of KR23343 in Healthy Adult Participants

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KR23343, and an Open-Label Assessment of Food's Effect on Its Pharmacokinetics in Healthy Adults

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: KR23343; Drug: Matching Placebo

Detailed Description

This first-in-human study will investigate the safety, tolerability, and pharmacokinetics (PK) of KR23343 following single and multiple ascending oral doses in healthy subjects, as well as assess the effect of food on the PK of KR23343. The results of this study will be used to select doses for subsequent studies in patients.

Primary objectives:

Stage 1: To assess the safety and tolerability of single ascending oral doses of KR23343 in healthy participants. Stage 3: To assess the safety and tolerability of multiple ascending oral doses of KR23343 in healthy participants.

Secondary objectives:

Stage 1: To assess the PK profile of KR23343 following single oral doses in healthy participants and evaluate the effect of KR23343 tablets on the corrected QT interval (QTcF) and other electrocardiogram (ECG) parameters. Stage 2: To assess the PK profile, safety and tolerability of a single dose of KR23343 following high-fat food intake relative to fasting conditions in healthy participants. Stage 3: To assess the PK profile of KR23343 after repeated oral doses in healthy participants.

• Study Type: Interventional
• Enrollment (Estimated): 92
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jing Zhang; Phone Number: 021-52887926; Email: zhangj_fudan@163.com
• Study Contact Backup: Name: Peimin Yu; Phone Number: 021-52888158

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy male or female participants aged 18 to 45 years, inclusive.
2. Body mass index (BMI) between 19 and 28 kg/m² (inclusive) and body weight ≥ 50 kg for males or ≥45 kg for females.
3. 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.
4. 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.
5. Able to understand study requirements, provide written informed consent, and comply with all trial procedures per protocol.

Exclusion Criteria:

1. Hypersensitivity or allergic to KR23343.
2. History of severe hypersensitivity reactions or multiple drug/food allergies
3. 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.
4. 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.
5. History of psychiatric disorders or cerebral dysfunction; suicidal ideation identified by the Columbia-Suicide Severity Rating Scale (C-SSRS) or investigator judgment; or history of self-harm behavior.
6. Abnormal screening investigations meeting any of the following criteria: a) Hepatic dysfunction: ALT or AST>1.5x upper limit of normal (ULN), or total bilirubin >1.3x ULN; b) Creatinine clearance <80 mL/min (calculated by Cockcroft-Gault formula: CrCl = [(140 - age) × weight (kg)] / [0.814 × Scr (μmol/L)], multiplied by 0.85 for females); c) Vital signs outside specified ranges (heart rate <50 or >100 bpm, systolic blood pressure <90 or ≥140 mmHg, diastolic blood pressure <60 or ≥90 mmHg, tympanic temperature <35.7 or >38.0°C); d) QTc-F interval ≥450 ms (males) or ≥470 ms (females), or other clinically significant ECG abnormalities; e) Any other screening abnormality deemed clinically significant by the investigator.
7. Blood loss or donation ≥400 mL within 3 months prior to screening, or planned donation during the study.
8. Use of any medication within 2 weeks (or 5 half-lives, whichever is longer) prior to screening or during the study, including prescription drugs, over-the-counter medications, Chinese herbal products, dietary supplements, vaccines, or any drug known to induce or inhibit hepatic metabolizing enzymes (e.g., CYP3A4, CYP3A5).
9. Participation in a clinical trial involving investigational products, vaccines, or devices within 3 months prior to screening, or within 5 half-lives of the last dose, whichever is longer.
10. History of drug abuse or illicit drug use within 6 months prior to screening, or positive urine drug screen.
11. Hazardous alcohol consumption ( >14 units/week; 1 unit = 360 mL beer, 25 mL 40% spirits, or 100 mL wine) within 6 months prior to screening, inability to abstain from screening through end-of-study, or positive alcohol breath test.
12. Smoking >10 cigarettes per day within the 3 months prior to screening, or inability to abstain from smoking and nicotine products during the trial.
13. Regular consumption of >8 cups/day (1 cup = 250 mL) of grapefruit juice, tea, coffee, or caffeinated beverages within the 3 months prior to screening, or inability to abstain during the trial.
14. Positive serology for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, Treponema pallidum antibody, or human immunodeficiency virus (HIV) antibody.
15. Pregnancy, lactation, or clinically significant abnormal pregnancy test as judged by the investigator.
16. Specific dietary restrictions or inability to adhere to the standardized diet during their CPU stay.
17. Difficult venous access, history of vasovagal syncope (needle or blood phobia), or inability to tolerate venipuncture.
18. Any condition or circumstance that, in the opinion of the Investigator, would make the participant unsuitable for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stage 1 Dose 1; Stage 1 Dose 1 Single dose of 10 mg	Drug: KR23343; Participants will recieve oral administrations of KR23343
Experimental: Stage 1 Dose 2; Stage 1 Dose 1 Single dose of 20 mg	Drug: KR23343; Participants will recieve oral administrations of KR23343
Experimental: Stage 1 Dose 3; Stage 1 Dose 3 Single dose of 30 mg	Drug: KR23343; Participants will recieve oral administrations of KR23343
Experimental: Stage 1 Dose 4; Stage 1 Dose 4 Single dose of 45 mg	Drug: KR23343; Participants will recieve oral administrations of KR23343
Experimental: Stage 1 Dose 5; Stage 1 Dose 5 Single dose of 60 mg	Drug: KR23343; Participants will recieve oral administrations of KR23343
Placebo Comparator: Stage 1 placebo; Stage 1 placebo Single dose of placebo	Drug: Matching Placebo; Participants will recieve placebo
Experimental: Stage 2 30 mg KR23343 Fed state; KR23343 oral single dose with food	Drug: KR23343; Participants will recieve oral administrations of KR23343
Experimental: Stage 2 30 mg KR23343 Fasted state; KR23343 oral single dose without food	Drug: KR23343; Participants will recieve oral administrations of KR23343
Experimental: Stage 3 Dose 1; KR23343 oral daily dose for 10 days (Dose 20mg QD )	Drug: KR23343; Participants will recieve oral administrations of KR23343
Experimental: Stage 3 Dose 2; KR23343 oral daily dose for 10 days (Dose 30mg QD )	Drug: KR23343; Participants will recieve oral administrations of KR23343
Experimental: Stage 3 Dose 3; KR23343 oral daily dose for 10 days (Dose 45 mg QD )	Drug: KR23343; Participants will recieve oral administrations of KR23343
Placebo Comparator: Stage 3 placebo; Placebo oral daily dose for 10 days	Drug: Matching Placebo; Participants will recieve placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	7 days in stage 1；21 days in stage 2; 16 days in stage 3.
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	7 days in stage 1；21 days in stage 2; 16 days in stage 3.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Plasma Concentration (Cmax) of Stage 1	Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of KR23343.	Day 1 up to 144 hours post-dose
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.	Day 1 up to 144 hours post-dose
Time to Cmax (Tmax) of Stage 1	Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of KR23343.	Day 1 up to 144 hours post-dose
Elimination Half-life（t1/2）of Stage1	Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of KR23343.	Day 1 up to 144 hours post-dose
Peak Plasma Concentration (Cmax) of Stage 2	Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of KR23343 under fasting and fed condition.	Day 1 up to 144 hours post-dose
Area Under the Plasma Concentration Versus Time Curve (AUC) of Stage 2	Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of KR23343 under fasting and fed condition.	Day 1 up to 144 hours post-dose
Time to Cmax (Tmax) of Stage 2	Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of KR23343 under fasting and fed condition.	Day 1 up to 144 hours post-dose
Elimination Half-life（t1/2）of Stage 2	Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of KR23343 under fasting and fed condition.	Day 1 up to 144 hours post-dose
Peak Plasma Concentration (Cmax) of Stage 3	Blood samples were collected at specified time points to perform pharmacokinetic (PK) analysis of multiple-dose KR23343	Day 1 up to 144 hours post-last dose
Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of Stage 3	Blood samples were collected at specified time points to perform pharmacokinetic (PK) analysis of multiple-dose KR23343	Day 1 up to 144 hours post-last dose
Time to Cmax (Tmax) of Stage 3	Blood samples were collected at specified time points to perform pharmacokinetic (PK) analysis of multiple-dose KR23343	Day 1 up to 144 hours post-last dose
Evaluation of the effect of time-matched plasma concentrations of KR23343 on electrocardiogram (ECG) parameters and the QTc interval, including concentration-QTc analysis for Stage 1	The placebo-corrected baseline-adjusted QTc (ΔΔQTc) was derived as the time-matched difference between the Day 1 change-from-baseline QTc values observed with KR23343 and those observed with placebo, calculated separately for each post-dose assessment timepoint.	Day 1 up to 144 hours post-dose

Collaborators and Investigators

• Sponsor: Jiangxi Kvvit Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): February 3, 2026
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): November 20, 2026

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: February 8, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 8, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: KR23343-202505

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No