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

NCT07409922 | Not Yet Recruiting Phase 1

• 1 other identifier: KR23343-202505
• Study Type: interventional
• Target: 92
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• Peak Plasma Concentration (Cmax) of Stage 1

  Day 1 up to 144 hours post-dose

• Area Under the Plasma Concentration Versus Time Curve (AUC) of Stage 1

  Day 1 up to 144 hours post-dose

• Time to Cmax (Tmax) of Stage 1

  Day 1 up to 144 hours post-dose

• Elimination Half-life（t1/2）of Stage1

  Day 1 up to 144 hours post-dose

• Peak Plasma Concentration (Cmax) of Stage 2

  Day 1 up to 144 hours post-dose

Study Arms (12)

Stage 1 Dose 1

EXPERIMENTAL

Stage 1 Dose 1 Single dose of 10 mg

Drug: KR23343

Stage 1 Dose 2

EXPERIMENTAL

Stage 1 Dose 1 Single dose of 20 mg

Drug: KR23343

Stage 1 Dose 3

EXPERIMENTAL

Stage 1 Dose 3 Single dose of 30 mg

Drug: KR23343

Stage 1 Dose 4

EXPERIMENTAL

Stage 1 Dose 4 Single dose of 45 mg

Drug: KR23343

Stage 1 Dose 5

EXPERIMENTAL

Stage 1 Dose 5 Single dose of 60 mg

Drug: KR23343

Stage 1 placebo

PLACEBO COMPARATOR

Stage 1 placebo Single dose of placebo

Drug: Matching Placebo

Stage 2 30 mg KR23343 Fed state

EXPERIMENTAL

KR23343 oral single dose with food

Drug: KR23343

Stage 2 30 mg KR23343 Fasted state

EXPERIMENTAL

KR23343 oral single dose without food

Drug: KR23343

Stage 3 Dose 1

EXPERIMENTAL

KR23343 oral daily dose for 10 days (Dose 20mg QD )

Drug: KR23343

Stage 3 Dose 2

EXPERIMENTAL

KR23343 oral daily dose for 10 days (Dose 30mg QD )

Drug: KR23343

Stage 3 Dose 3

EXPERIMENTAL

KR23343 oral daily dose for 10 days (Dose 45 mg QD )

Drug: KR23343

Stage 3 placebo

PLACEBO COMPARATOR

Placebo oral daily dose for 10 days

Drug: Matching Placebo

Interventions

KR23343 DRUG

Participants will recieve oral administrations of KR23343

Stage 1 Dose 1; Stage 1 Dose 2; Stage 1 Dose 3; Stage 1 Dose 4; Stage 1 Dose 5; Stage 2 30 mg KR23343 Fasted state; Stage 2 30 mg KR23343 Fed state; Stage 3 Dose 1; Stage 3 Dose 2; Stage 3 Dose 3

Matching Placebo DRUG

Participants will recieve placebo

Stage 1 placebo; Stage 3 placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Able to understand study requirements, provide written informed consent, and comply with all trial procedures per protocol.

You may not qualify if:

• 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.
• 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.
• 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.
• Blood loss or donation ≥400 mL within 3 months prior to screening, or planned donation during the study.
• 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).
• 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.
• History of drug abuse or illicit drug use within 6 months prior to screening, or positive urine drug screen.
• 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.
• Smoking \>10 cigarettes per day within the 3 months prior to screening, or inability to abstain from smoking and nicotine products during the trial.
• 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.
• Positive serology for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, Treponema pallidum antibody, or human immunodeficiency virus (HIV) antibody.
• Pregnancy, lactation, or clinically significant abnormal pregnancy test as judged by the investigator.

Sponsors & Collaborators

• Jiangxi Kvvit Pharmaceutical Co., Ltd.: lead

Central Study Contacts

Jing Zhang

CONTACT

021-52887926; zhangj_fudan@163.com

Peimin Yu

CONTACT

021-52888158

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study will be conducted in 3 sequential stages: Stage 1 will investigate single ascending oral doses of KR23343；Stage 2 is a 2-way crossover assessment of the effect of food on the PK of KR23343; and Stage 3 will investigate multiple ascending oral doses of KR23343.

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 13, 2026
• Study Start: February 3, 2026
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): November 20, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02