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

ConditionSchizophrenia
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorJiangxi Kvvit Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • KR23248

    Drug

    Participants will recieve a single oral dose of KR23248

  • Matching Placebo

    Drug

    Participants will recieve placebo

Treatment groups

66 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Group A: Part 1 cohort 1Experimental treatment 1 intervention
Group B: Part 1 cohort 2Experimental treatment 1 intervention
Group C: Part 1 cohort 3Experimental treatment 1 intervention
Group D: Part 1 cohort 4Experimental treatment 1 intervention
Group E: Part 1 cohort 5Experimental treatment 1 intervention
Group F: Part 1 cohort 6Experimental treatment 1 intervention
Group G: Part 1 cohort 7Placebo comparator 1 intervention
Group H: Part 2 KR23248 2.0mgExperimental treatment 1 intervention
Group I: Part 2 PlaceboPlacebo comparator 1 intervention

Trial outcomes

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

Time frame
SAD:Day 1 to Day14 MAD:Day1 to Day28

Secondary outcomes

1

Cmax

Maximum Serum Concentration

Time frame
SAD:Day 1 to Day14 MAD:Day1 to Day28
2

Tmax

Time to Reach the Maximum Serum Concentration

Time frame
SAD:Day 1 to Day14 MAD:Day1 to Day28
3

t1/2

Elimination half-life

Time frame
SAD:Day 1 to Day14 MAD:Day1 to Day28
4

λz

Terminal rate constant

Time frame
SAD:Day 1 to Day14 MAD:Day1 to Day28

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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