A Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of KR23248 Capsules in Healthy Adult Subjects

NCT07585383 | Not Yet Recruiting Phase 1

• 1 other identifier: KR23248-202509
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• 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

  SAD:Day 1 to Day14 MAD:Day1 to Day28

Secondary Outcomes (16)

• Cmax

  SAD:Day 1 to Day14 MAD:Day1 to Day28

• Tmax

  SAD:Day 1 to Day14 MAD:Day1 to Day28

• t1/2

  SAD:Day 1 to Day14 MAD:Day1 to Day28

• λz

  SAD:Day 1 to Day14 MAD:Day1 to Day28

• AUC0-t

  SAD:Day 1 to Day14 MAD:Day1 to Day28

Study Arms (9)

Part 1 cohort 1

EXPERIMENTAL

SAD Cohort 1: single oral dose of 0.5mg KR23248 capsule

Drug: KR23248

Part 1 cohort 2

EXPERIMENTAL

SAD Cohort 2: single oral dose of 1.0mg KR23248 capsule

Drug: KR23248

Part 1 cohort 3

EXPERIMENTAL

SAD Cohort 3: single oral dose of 2.0mg KR23248 capsule

Drug: KR23248

Part 1 cohort 4

EXPERIMENTAL

SAD Cohort 4: single oral dose of 3.0mg KR23248 capsule

Drug: KR23248

Part 1 cohort 5

EXPERIMENTAL

SAD Cohort 5: single oral dose of 4.5mg KR23248 capsule

Drug: KR23248

Part 1 cohort 6

EXPERIMENTAL

SAD Cohort 6: single oral dose of 6.0mg KR23248 capsule

Drug: KR23248

Part 1 cohort 7

PLACEBO COMPARATOR

SAD cohort 7: single oral dose of placebo capsule

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

Drug: KR23248

Part 2 Placebo

PLACEBO COMPARATOR

MAD: Multiple oral doses of placebo capsules administered once daily for 14 consecutive days

Drug: Matching Placebo

Interventions

KR23248 DRUG

Participants will recieve a single oral dose of KR23248

Also known as: KR23248 capsule

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 Placebo DRUG

Participants will recieve placebo

Also known as: Placebo capsule

Part 1 cohort 7; Part 2 Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Jiangxi Kvvit Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Huafang Li

CONTACT

+8618017311256; lhlh_5@163.com

Yan Li

CONTACT

+8613046600636; liyan7721@163.com

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

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 13, 2026
• Study Start: May 19, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share