HealthyPhase 1NCT07409922
Study of Single and Multiple Ascending Doses of KR23343 in Healthy Adult Participants
A Phase 1 study testing KR23343 in people with Healthy, run by Jiangxi Kvvit Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- KR23343
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 5 Feb 2026to 20 Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Specific dietary restrictions or inability to adhere to the standardized diet during their CPU stay.
- Difficult venous access, history of vasovagal syncope (needle or blood phobia), or inability to tolerate venipuncture.
- Any condition or circumstance that, in the opinion of the Investigator, would make the participant unsuitable for the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Peimin Yu contact
China1 site, 1 recruiting
- Recruiting
Huashan Hospital, Fudan University
Shanghai
Jing Zhang, 021-52887926
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- KR23343, Matching Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KR23343Drug
Participants will receive oral administrations of KR23343
Matching PlaceboDrug
Participants will receive placebo
| Study group | Role | What they receive |
|---|---|---|
| Stage 1 Dose 1 | Experimental | Stage 1 Dose 1 Single dose of 10 mg Receives: Drug: KR23343 |
| Stage 1 Dose 2 | Experimental | Stage 1 Dose 1 Single dose of 20 mg Receives: Drug: KR23343 |
| Stage 1 Dose 3 | Experimental | Stage 1 Dose 3 Single dose of 30 mg Receives: Drug: KR23343 |
| Stage 1 Dose 4 | Experimental | Stage 1 Dose 4 Single dose of 45 mg Receives: Drug: KR23343 |
| Stage 1 Dose 5 | Experimental | Stage 1 Dose 5 Single dose of 60 mg Receives: Drug: KR23343 |
| Stage 1 placebo | Placebo comparator | Stage 1 placebo Single dose of placebo Receives: Drug: Matching Placebo |
| Stage 2 30 mg KR23343 Fed state | Experimental | KR23343 oral single dose with food Receives: Drug: KR23343 |
| Stage 2 30 mg KR23343 Fasted state | Experimental | KR23343 oral single dose without food Receives: Drug: KR23343 |
| Stage 3 Dose 1 | Experimental | KR23343 oral daily dose for 10 days (Dose 20mg QD ) Receives: Drug: KR23343 |
| Stage 3 Dose 2 | Experimental | KR23343 oral daily dose for 10 days (Dose 30mg QD ) Receives: Drug: KR23343 |
| Stage 3 Dose 3 | Experimental | KR23343 oral daily dose for 10 days (Dose 45 mg QD ) Receives: Drug: KR23343 |
| Stage 3 placebo | Placebo comparator | Placebo oral daily dose for 10 days Receives: Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of KR23343.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Day 1 up to 144 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start5 Feb 2026
- Primary completion20 Nov 2026 (estimated)
- Study completion20 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangxi Kvvit Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409922
- Sponsor's protocol ID
- KR23343-202505
- Status last verified
- Aug 2026
- First submitted
- 2 Feb 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07409922
- Acronym / sponsor ID
- KR23343-202505
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Jiangxi Kvvit Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- 20 Nov 2026 (estimated)
- Study completion
- 20 Nov 2026 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 12
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Stage 1 Dose 1 | Experimental | Drug: KR23343Stage 1 Dose 1 Single dose of 10 mg |
| Stage 1 Dose 2 | Experimental | Drug: KR23343Stage 1 Dose 1 Single dose of 20 mg |
| Stage 1 Dose 3 | Experimental | Drug: KR23343Stage 1 Dose 3 Single dose of 30 mg |
| Stage 1 Dose 4 | Experimental | Drug: KR23343Stage 1 Dose 4 Single dose of 45 mg |
| Stage 1 Dose 5 | Experimental | Drug: KR23343Stage 1 Dose 5 Single dose of 60 mg |
| Stage 1 placebo | Placebo comparator | Drug: Matching PlaceboStage 1 placebo Single dose of placebo |
| Stage 2 30 mg KR23343 Fed state | Experimental | Drug: KR23343KR23343 oral single dose with food |
| Stage 2 30 mg KR23343 Fasted state | Experimental | Drug: KR23343KR23343 oral single dose without food |
| Stage 3 Dose 1 | Experimental | Drug: KR23343KR23343 oral daily dose for 10 days (Dose 20mg QD ) |
| Stage 3 Dose 2 | Experimental | Drug: KR23343KR23343 oral daily dose for 10 days (Dose 30mg QD ) |
| Stage 3 Dose 3 | Experimental | Drug: KR23343KR23343 oral daily dose for 10 days (Dose 45 mg QD ) |
| Stage 3 placebo | Placebo comparator | Drug: Matching PlaceboPlacebo oral daily dose for 10 days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KR23343Participants will receive oral administrations of KR23343 | Drug | 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 PlaceboParticipants will receive placebo | Drug | Stage 1 placebo, Stage 3 placebo |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events, Serious Adverse Event(s) (SAEs), And Adverse Events Leading To Study Discontinuation
Time frame: 7 days in stage 1；21 days in stage 2; 16 days in stage 3.
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
Number of participants with abnormal laboratory test results, abnormal vital signs, abnormal physical examination findings, and abnormal ECG parameters
Time frame: 7 days in stage 1；21 days in stage 2; 16 days in stage 3.
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
12 secondary outcomes
Peak Plasma Concentration (Cmax) of Stage 1
Time frame: Day 1 up to 144 hours post-dose
Area Under the Plasma Concentration Versus Time Curve (AUC) of Stage 1
Time frame: Day 1 up to 144 hours post-dose
Time to Cmax (Tmax) of Stage 1
Time frame: Day 1 up to 144 hours post-dose
Elimination Half-life（t1/2）of Stage1
Time frame: Day 1 up to 144 hours post-dose
Peak Plasma Concentration (Cmax) of Stage 2
Time frame: Day 1 up to 144 hours post-dose
Area Under the Plasma Concentration Versus Time Curve (AUC) of Stage 2
Time frame: Day 1 up to 144 hours post-dose
Time to Cmax (Tmax) of Stage 2
Time frame: Day 1 up to 144 hours post-dose
Elimination Half-life（t1/2）of Stage 2
Time frame: Day 1 up to 144 hours post-dose
Peak Plasma Concentration (Cmax) of Stage 3
Time frame: 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
Time frame: Day 1 up to 144 hours post-last dose
Time to Cmax (Tmax) of Stage 3
Time frame: 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
Time frame: Day 1 up to 144 hours post-dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peimin Yu contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KR23343 in people with Healthy, run by Jiangxi Kvvit Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jing Zhang (021-52887926, zhangj_fudan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Emergent Adverse Events, Serious Adverse Event(s) (SAEs), And Adverse Events Leading To Study Discontinuation (time frame: 7 days in stage 1；21 days in stage 2; 16 days in stage 3.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.