Recruiting soon

Safety, Tolerability, and Pharmacokinetics Evaluation of KR23343 in Healthy Adults

Study Aim

This study aims to evaluate the safety and tolerability of KR23343 in healthy adults by monitoring abnormal laboratory test results, vital signs, physical examinations, and ECG parameters, as well as recording any treatment-emergent adverse events, serious adverse events, and adverse events leading to study discontinuation.

What is being tested

KR23343

+ Matching Placebo

Drug

Who is being recruted

From 18 to 45 Years

+23 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 1

Interventional

Study Start: February 2026

See protocol details

Summary

Principal SponsorJiangxi Kvvit Pharmaceutical Co., Ltd.

Study ContactJing ZhangMore contacts

Last updated: February 14, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: February 3, 2026

Actual date on which the first participant was enrolled.

This study is the first in humans and aims to understand the safety, tolerability, and how the body processes a new drug called KR23343. The study involves healthy adults and will look at how the drug works after single and multiple doses, as well as how food affects its processing. The goal is to find safe doses for future studies involving patients. This research is important as it helps lay the foundation for the development of new treatments. During the study, participants will receive either KR23343 or a placebo (a pill with no active ingredients). The effects of the drug will be monitored through various tests, including blood tests, physical examinations, and heart activity checks (ECGs). These tests will be done before and after the drug is given. The study will also record any side effects or adverse events. The main goals are to see how many participants have abnormal test results, physical examination findings, or heart activity changes, and to count the number of participants who experience side effects or serious adverse events.

Official TitleA 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

NCT07409922

Principal SponsorJiangxi Kvvit Pharmaceutical Co., Ltd.

Study ContactJing ZhangMore contacts

Last updated: February 14, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

92 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate

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.

Show More Criteria

18 exclusion criteria prevent from participating

Hypersensitivity or allergic to KR23343.

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.

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.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

12 intervention groups are designated in this study

16.667% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Stage 1 Dose 1 Single dose of 10 mg

Group II

Experimental

Stage 1 Dose 1 Single dose of 20 mg

Group III

Experimental

Stage 1 Dose 3 Single dose of 30 mg

Group IV

Experimental

Stage 1 Dose 4 Single dose of 45 mg

Group 5

Experimental

Stage 1 Dose 5 Single dose of 60 mg

Group 6

Experimental

KR23343 oral single dose without food

Group 7

Experimental

KR23343 oral single dose with food

Group 8

Experimental

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

Group 9

Experimental

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

Group 10

Experimental

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

Group 11

Placebo

Stage 1 placebo Single dose of placebo

Group 12

Placebo

Placebo oral daily dose for 10 days

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has no location dataSave this study to your profile to know when the location data is available.

Recruiting soonNo study centers