SchizophreniaPhase 1NCT07585383
A Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of KR23248 Capsules in Healthy Adult Subjects
A Phase 1 study testing KR23248 in people with Schizophrenia, run by Jiangxi Kvvit Pharmaceutical Co., Ltd..
Trial summary
This study aims to investigate the safety, tolerability and pharmacokinetic characteristics of KR23248 capsules in healthy subjects. This study will be conducted in China. It will enroll male and female participants aged 18 years to 45 years. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- KR23248
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 19 May 2026to 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/female subjects aged ≥ 18 years and ≤ 45 years (inclusive) at the time of signing the informed consent form.
- Body Mass Index (BMI) ranging from 18.5 to 28.0 kg/m² (inclusive) at screening; male subjects with body weight ≥50 kg and female subjects with body weight ≥45 kg.
- Subjects who voluntarily participate in the trial and sign the informed consent form after understanding the purpose, content, procedures, and potential risks of the trial.
- Subjects who can communicate well with the investigators, are willing and able to comply with lifestyle restrictions specified in the protocol, and cooperate with study procedures.
Who cannot join
- Subjects with any diseases or dysfunctions in present illness and medical history that may interfere with the clinical trial, including but not limited to neurological and psychiatric diseases, cardiovascular diseases (e.g., congenital long QT syndrome), urinary system disorders, digestive system disorders, respiratory system disorders, musculoskeletal system disorders, metabolic and endocrine system disorders, skin diseases, hematological diseases, immune system diseases, and tumors.
- Subjects with any surgical condition or medical history that may significantly affect drug absorption, distribution, metabolism and excretion, or may pose a risk to the subject participating in the trial; such as a history of gastrointestinal surgery (gastrectomy, gastroenterostomy, enterectomy, etc.), urinary tract obstruction or dysuria, gastroenteritis, peptic ulcer, and history of gastrointestinal bleeding.
- Subjects with a history of severe allergic reactions or known hypersensitivity to any ingredients of the investigational product.
- Subjects with current or previous psychiatric disorders or cerebral dysfunction; those assessed to be at suicide risk based on the Columbia-Suicide Severity Rating Scale (C-SSRS), or by the investigator's clinical assessment, or those with a history of self-harm behavior.
- Subjects with a history of substance abuse within 1 year prior to administration or with a positive urine drug screening result.
- Subjects with a history of alcohol abuse within 6 months prior to screening (i.e., more than 14 standard units per week; 1 standard unit = 360 mL beer, or 45 mL spirits with 40% alcohol content, or 150 mL wine); or with a positive breath alcohol test; or unwilling to abstain from alcohol and any alcohol-containing products from screening until the last PK blood collection.
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- Subjects with a history of surgery within 3 months prior to screening, or who have not recovered from surgery, or have a planned surgery scheduled during the trial.
- Subjects who have donated blood or experienced blood loss ≥ 400 mL within 3 months prior to screening, or ≥ 200 mL within one month, or have a history of blood product transfusion.
- Subjects who have participated in any clinical trial and received investigational drugs or medical devices within 3 months prior to screening.
- Subjects who have received vaccination within 30 days prior to screening, or have a vaccination plan during the entire study period.
- Subjects who have taken any medications within 28 days or 5 half-lives (whichever is longer) prior to screening and during the entire study period, including prescription drugs, over-the-counter drugs, herbal medicines, and any drugs that inhibit or induce hepatic drug-metabolizing enzymes (e.g., inducers and/or inhibitors of CYP3A4, CYP2D6, and CYP3A5).
- Female subjects who are pregnant, breastfeeding, or have a positive pregnancy test; or those who refuse to adopt effective non-pharmacological contraceptive measures (e.g., abstinence, intrauterine device, condoms with vaginal spermicide) throughout the study period and within 28 days after the end of administration; or those with a plan to donate sperm or ova.
- Subjects with clinically significant abnormal findings judged by the investigator in comprehensive physical examination, vital signs, laboratory tests and 12-lead electrocardiogram; including but not limited to: QTc > 450 ms in males and > 470 ms in females (Fridericia correction); resting pulse rate < 55 beats/min or > 100 beats/min; systolic blood pressure < 90 mmHg or ≥ 140 mmHg; diastolic blood pressure < 60 mmHg or ≥ 90 mmHg.
- Subjects with non-negative results for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV-Ab), Human Immunodeficiency Virus antibody (HIV-Ab), and Toluidine Red Untreated Serum Test (TRUST).
- Subjects with alanine transaminase (ALT), creatinine (Cr) or serum prolactin level exceeding 2 times the upper limit of normal during the screening period.
- Subjects who smoke an average of ≥ 5 cigarettes per day within 3 months prior to screening, or are unable to abstain from any tobacco products during the trial.
- Subjects with an average daily intake of ≥ 5 cups of coffee or tea (200 mL per cup) within 3 months prior to screening, or are unable to discontinue intake during the trial.
- Subjects with special dietary requirements who cannot follow a unified study diet, or have difficulty in swallowing.
- Subjects who have consumed food or beverages containing grapefruit and/or pomelo within 7 days prior to administration.
- Subjects who have consumed xanthine-rich food or beverages (e.g., tea, coffee, cola, chocolate) within 3 days prior to administration.
- Subjects with poor compliance or other conditions deemed unsuitable for participation in the trial by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Dose-escalating Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of Single and Multiple Doses of KR23248 Capsules in Healthy Adult Subjects
This study aims to investigate the safety, tolerability and pharmacokinetic characteristics of KR23248 capsules in healthy subjects. This study will be conducted in China. It will enroll male and female participants aged 18 years to 45 years.
Read the detailed description
This study is a randomized, double-blind, placebo-controlled, dose-escalating Phase I trial, aiming to evaluate the safety, tolerability, and pharmacokinetic (PK) profiles of single and multiple oral doses of KR23248 capsules in healthy adult subjects. The study consists of two parts: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) studies.
The single ascending dose study plans to enroll 54 healthy subjects, with predefined dose escalation levels of 0.5 mg, 1.0 mg, 2.0 mg, 3.0 mg, 4.5 mg, and 6.0 mg in sequence. The multiple ascending dose study sets the initial dose at 2.0 mg, with 12 healthy subjects planned for enrollment.
- Conditions
- Schizophrenia
- Being tested
- KR23248, Matching Placebo
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KR23248Drug
Also called KR23248 capsule
Participants will recieve a single oral dose of KR23248
Matching PlaceboDrug
Also called Placebo capsule
Participants will recieve placebo
| Study group | Role | What they receive |
|---|---|---|
| Part 1 cohort 1 | Experimental | SAD Cohort 1: single oral dose of 0.5mg KR23248 capsule Receives: Drug: KR23248 |
| Part 1 cohort 2 | Experimental | SAD Cohort 2: single oral dose of 1.0mg KR23248 capsule Receives: Drug: KR23248 |
| Part 1 cohort 3 | Experimental | SAD Cohort 3: single oral dose of 2.0mg KR23248 capsule Receives: Drug: KR23248 |
| Part 1 cohort 4 | Experimental | SAD Cohort 4: single oral dose of 3.0mg KR23248 capsule Receives: Drug: KR23248 |
| Part 1 cohort 5 | Experimental | SAD Cohort 5: single oral dose of 4.5mg KR23248 capsule Receives: Drug: KR23248 |
| Part 1 cohort 6 | Experimental | SAD Cohort 6: single oral dose of 6.0mg KR23248 capsule Receives: Drug: KR23248 |
| Part 1 cohort 7 | Placebo comparator | SAD cohort 7: single oral dose of placebo capsule Receives: Drug: Matching Placebo |
| Part 2 KR23248 2.0mg | Experimental | MAD: Multiple oral doses of 2.0mg KR23248 capsules administered once daily for 14 consecutive days Receives: Drug: KR23248 |
| Part 2 Placebo | Placebo comparator | MAD: Multiple oral doses of placebo capsules administered once daily for 14 consecutive days Receives: Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs), serious adverse events（SAEs）, drug-related AEs, and AEs leading to study withdrawal
The number and percentage of participants with AEs,SAEs, drug-related AEs, and AEs leading to study withdrawal will be determined
Measured: SAD:Day 1 to Day14 MAD:Day1 to Day28
Secondary outcomes (16)
Cmax
Maximum Serum Concentration
Measured: SAD:Day 1 to Day14 MAD:Day1 to Day28
Tmax
Time to Reach the Maximum Serum Concentration
Measured: SAD:Day 1 to Day14 MAD:Day1 to Day28
t1/2
Elimination half-life
Measured: SAD:Day 1 to Day14 MAD:Day1 to Day28
λz
Terminal rate constant
Measured: SAD:Day 1 to Day14 MAD:Day1 to Day28
AUC0-t
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration
Measured: SAD:Day 1 to Day14 MAD:Day1 to Day28
AUC0-∞
Area under the plasma concentration-time curve from time zero extrapolated to infinity
Measured: SAD:Day 1 to Day14 MAD:Day1 to Day28
CL/F
Apparent Clearance
Measured: SAD:Day 1 to Day14 MAD:Day1 to Day28
Vd/F
Apparent Volume of Distribution
Measured: SAD:Day 1 to Day14 MAD:Day1 to Day28
MRT
Mean residence time
Measured: SAD: Day1 to D14 MAD:Day1 to Day28
Css_min
Steady-state trough concentration
Measured: MAD:Day1 to Day28
Css_max
Steady-state peak concentration
Measured: MAD:Day1 to Day28
Tss,max
Time to Reach Maximum Concentration at Steady State
Measured: MAD:Day1 to Day28
Cavg,ss
Average Steady-State Concentration
Measured: MAD:Day1 to Day28
DF
Fluctuation Percentage
Measured: MAD:Day1 to Day28
Rac
Accumulation Factor
Measured: MAD:Day1 to Day28
AUCss
Area under the plasma concentration-time curve over a dosing interval at steady state
Measured: MAD:Day1 to Day28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start19 May 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 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
- NCT07585383
- Sponsor's protocol ID
- KR23248-202509
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Dose-escalating Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of Single and Multiple Doses of KR23248 Capsules in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT07585383
- Acronym / sponsor ID
- KR23248-202509
- Conditions
- Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Jiangxi Kvvit Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 May 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 13 May 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 study aims to investigate the safety, tolerability and pharmacokinetic characteristics of KR23248 capsules in healthy subjects. This study will be conducted in China. It will enroll male and female participants aged 18 years to 45 years.
Detailed description
This study is a randomized, double-blind, placebo-controlled, dose-escalating Phase I trial, aiming to evaluate the safety, tolerability, and pharmacokinetic (PK) profiles of single and multiple oral doses of KR23248 capsules in healthy adult subjects. The study consists of two parts: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) studies.
The single ascending dose study plans to enroll 54 healthy subjects, with predefined dose escalation levels of 0.5 mg, 1.0 mg, 2.0 mg, 3.0 mg, 4.5 mg, and 6.0 mg in sequence. The multiple ascending dose study sets the initial dose at 2.0 mg, with 12 healthy subjects planned for enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Part 1 cohort 1 | Experimental | Drug: KR23248SAD Cohort 1: single oral dose of 0.5mg KR23248 capsule |
| Part 1 cohort 2 | Experimental | Drug: KR23248SAD Cohort 2: single oral dose of 1.0mg KR23248 capsule |
| Part 1 cohort 3 | Experimental | Drug: KR23248SAD Cohort 3: single oral dose of 2.0mg KR23248 capsule |
| Part 1 cohort 4 | Experimental | Drug: KR23248SAD Cohort 4: single oral dose of 3.0mg KR23248 capsule |
| Part 1 cohort 5 | Experimental | Drug: KR23248SAD Cohort 5: single oral dose of 4.5mg KR23248 capsule |
| Part 1 cohort 6 | Experimental | Drug: KR23248SAD Cohort 6: single oral dose of 6.0mg KR23248 capsule |
| Part 1 cohort 7 | Placebo comparator | Drug: Matching PlaceboSAD cohort 7: single oral dose of placebo capsule |
| Part 2 KR23248 2.0mg | Experimental | Drug: KR23248MAD: Multiple oral doses of 2.0mg KR23248 capsules administered once daily for 14 consecutive days |
| Part 2 Placebo | Placebo comparator | Drug: Matching PlaceboMAD: Multiple oral doses of placebo capsules administered once daily for 14 consecutive days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male/female subjects aged ≥ 18 years and ≤ 45 years (inclusive) at the time of signing the informed consent form.
- Body Mass Index (BMI) ranging from 18.5 to 28.0 kg/m² (inclusive) at screening; male subjects with body weight ≥50 kg and female subjects with body weight ≥45 kg.
- Subjects who voluntarily participate in the trial and sign the informed consent form after understanding the purpose, content, procedures, and potential risks of the trial.
- Subjects who can communicate well with the investigators, are willing and able to comply with lifestyle restrictions specified in the protocol, and cooperate with study procedures.
Key exclusion criteria (21 listed)
- Subjects with any diseases or dysfunctions in present illness and medical history that may interfere with the clinical trial, including but not limited to neurological and psychiatric diseases, cardiovascular diseases (e.g., congenital long QT syndrome), urinary system disorders, digestive system disorders, respiratory system disorders, musculoskeletal system disorders, metabolic and endocrine system disorders, skin diseases, hematological diseases, immune system diseases, and tumors.
- Subjects with any surgical condition or medical history that may significantly affect drug absorption, distribution, metabolism and excretion, or may pose a risk to the subject participating in the trial; such as a history of gastrointestinal surgery (gastrectomy, gastroenterostomy, enterectomy, etc.), urinary tract obstruction or dysuria, gastroenteritis, peptic ulcer, and history of gastrointestinal bleeding.
- Subjects with a history of severe allergic reactions or known hypersensitivity to any ingredients of the investigational product.
- Subjects with current or previous psychiatric disorders or cerebral dysfunction; those assessed to be at suicide risk based on the Columbia-Suicide Severity Rating Scale (C-SSRS), or by the investigator's clinical assessment, or those with a history of self-harm behavior.
- Subjects with a history of substance abuse within 1 year prior to administration or with a positive urine drug screening result.
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 |
|---|---|---|
| KR23248Also: KR23248 capsuleParticipants will recieve a single oral dose of KR23248 | Drug | Part 1 cohort 1, Part 1 cohort 2, Part 1 cohort 3, Part 1 cohort 4, Part 1 cohort 5, Part 1 cohort 6, Part 2 KR23248 2.0mg |
| Matching PlaceboAlso: Placebo capsuleParticipants will recieve placebo | Drug | Part 1 cohort 7, Part 2 Placebo |
Primary outcome
Incidence of adverse events (AEs), serious adverse events（SAEs）, drug-related AEs, and AEs leading to study withdrawal
Time frame: SAD:Day 1 to Day14 MAD:Day1 to Day28
The number and percentage of participants with AEs,SAEs, drug-related AEs, and AEs leading to study withdrawal will be determined
16 secondary outcomes
Cmax
Time frame: SAD:Day 1 to Day14 MAD:Day1 to Day28
Tmax
Time frame: SAD:Day 1 to Day14 MAD:Day1 to Day28
t1/2
Time frame: SAD:Day 1 to Day14 MAD:Day1 to Day28
λz
Time frame: SAD:Day 1 to Day14 MAD:Day1 to Day28
AUC0-t
Time frame: SAD:Day 1 to Day14 MAD:Day1 to Day28
AUC0-∞
Time frame: SAD:Day 1 to Day14 MAD:Day1 to Day28
CL/F
Time frame: SAD:Day 1 to Day14 MAD:Day1 to Day28
Vd/F
Time frame: SAD:Day 1 to Day14 MAD:Day1 to Day28
MRT
Time frame: SAD: Day1 to D14 MAD:Day1 to Day28
Css_min
Time frame: MAD:Day1 to Day28
Css_max
Time frame: MAD:Day1 to Day28
Tss,max
Time frame: MAD:Day1 to Day28
Cavg,ss
Time frame: MAD:Day1 to Day28
DF
Time frame: MAD:Day1 to Day28
Rac
Time frame: MAD:Day1 to Day28
AUCss
Time frame: MAD:Day1 to Day28
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 15 May 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KR23248 in people with Schizophrenia, run by Jiangxi Kvvit Pharmaceutical Co., Ltd..
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 4 inclusion and 21 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: opening soon, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Huafang Li (+8618017311256, lhlh_5@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs), serious adverse events（SAEs）, drug-related AEs, and AEs leading to study withdrawal (time frame: SAD:Day 1 to Day14 MAD:Day1 to Day28). 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 15 May 2026.