An Open-label, Single-Dose Study to Investigate the Pharmacokinetics of KSP-1007 in Healthy Adult Chinese Subjects

JRCT ID: jRCT2071230099

Registered date:06/12/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Hospital-acquired pneumonia including ventilator-associated pneumonia
• Date of first enrollment: 18/12/2023
• Target sample size: 32
• Study type: Interventional
• Intervention(s): Administer KSP-1007 (250, 500, 750, or 1000 mg) by intravenous infusion over 3 hours.

Outcome(s)

• Primary Outcome: Pharmacokinetics parameters
• Secondary Outcome: Adverse events, clinical laboratory tests, vital signs, and 12-lead electrocardiogram

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 45age old
• Gender: Both

Include criteria

1) Chinese healthy adult subject between 20-45 years of age (inclusive) at the time of consent.
2) Subject who is fully informed and understands the objectives, procedures, anticipated drug effects/pharmacological action and risks of the study and who voluntarily provides written consent to participate in the study.
3) Male subject's body weight must be between 50.0 kg and 80.0 kg and body mass index (BMI) must be at least 18.5 kg/m2 but no more than 30.0 kg/m2 at screening. Female subject's body weight must be between 45.0 kg and 80.0 kg and body mass index (BMI) must be at least 17.6 kg/m2 but no more than 30.0 kg/m2 at screening.
4) Subject who is able to comply with the study requirements, including physical examination, assessments, and reporting symptoms.
5) Female subject of childbearing potential or subject with a partner of childbearing potential must agree to practice abstinence, consistent with lifestyle or to use acceptable birth control from signing informed consent to 30 days after the last study drug administration.
6) Subject must possess an educational level and degree of understanding of Japanese or Chinese that enables them to communicate suitably with investigators and study staff.
7) Female subject of childbearing potential must have a negative serum pregnancy test at screening and Day -1.

Exclude criteria

1) Subject with a clinically significant history of cardiovascular, hepatic, renal, endocrine, gastrointestinal, hematological, respiratory, neurologic disease other than Parkinson's disease, or dermatological determined by the investigator.
2) Subject with an abnormal 12-lead ECG that may jeopardize the subject's safety if he/she participates in the study, or a screening 12-lead ECG that demonstrated any one of the following:
- Heart rate > 100 bpm or < 50 bpm
- QRS interval > 120 msec
- QTcF > 450 msec for males and QTcF > 470 msec for females (QTcF = QT/RR1/3)
- PR interval > 200 msec
3) Subject who has a history of drug allergy.
4) Subject who has a positive immunology at screening.
5) Subject who has a history of excessive alcohol consumption (roughly defined as drinking at least 1.3 L of beer or 360 mL of sake daily) within 6 months before screening.
6) Subject who ordinarily drinks large quantities (approximately 1.8 L daily or more) of caffeinated beverages (coffee, tea, green tea, cola, tonic drink, etc.).
7) Subject with a history of tobacco dependency or subject who smokes, on average, more than 20 cigarettes daily.
8) Subject who has previously received KSP-1007.
9) Subject who has participated in an investigational drug study and received any investigational drug within 90 days prior to screening visit, or who is currently participating in another clinical trial.
10) Subject with a history of hospitalization within 45 days prior to screening visit (unless due to tests).
11) Subject with a disorder or history of a condition that may interfere with drug metabolism or excretion (including a subject with a clinically significant abnormality of the hepatic or renal system).
12) Subjects who cannot abstain from alcohol and smoking during hospitalization.
13) Subject who has a clinically significant abnormality in hematology test, blood chemistry (serum) test, or urinalysis at screening or Day -1.
14) Subject with a history of alcohol or drug abuse, or a positive urine drug test at screening or on Day -1.
15) Subject who has experienced significant blood loss during the 90 days prior to the initial study drug administration or donated blood (>= 400 mL) within 90 days before Day 1 for male and 120 days before Day 1 for female or donated 200 mL of blood or more during the 30 days prior to the initial study drug administration; has donated blood components during the 14 days prior to the initial study drug administration or intends to donate blood components or blood during the 30 days after the last study visit.
16) Subject who has used prescription or over-the-counter medications (except for oral contraceptives) within 14 days prior to the initial study drug administration.
17) Subject who has consumed alcohol between the day before and the time of screening test or on Day -2 and thereafter.
18) Female subject who is pregnant or lactating.
19) Subjects who have any medical problem and are considered ineligible for the study in the opinion of the investigator on the basis of the results of physical examination or other examinations performed at each time point to evaluate the current health condition.
20) Subject who does not tolerate venipuncture or has poor venous access that would cause difficulty for collecting blood samples.
21) Subject who is in the opinion of the investigator unsuitable in any other way to participate in this study.
22) Subject with a positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acid amplification test, or clinical symptoms suggestive of infection with SARS-CoV-2.

Related Information

• Primary Sponsor: Tsukada Hironobu
• Source(s) of Monetary Support: Japan Agency of Medical Research and Development