Study in Healthy Volunteers to Document Safety and Tolerability of Increasing Doses Pemirolast

Study Overview
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Brief Summary
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This study is a single-centre, open-label, dose escalation , safety, tolerability and pharmacokinetics (PK) study in healthy male and female subjects. The study include a screening day and a 5-day dosing period. Subjects will be enrolled in sequential cohorts and each cohort will include 8 subjects. there will be 24 subjects total included in the study. The duration of the clinical part of the study will be approximately 2 months.

Detailed Description
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Subjects meeting the eligibility criteria at screening will remain in the clinic from the evening preceding the first day of dosing (Day - 1) of the investigational medical product (IMP) and check out from the clinic 24 hours after the first dose administration of the IMP (in the morning of Day 2). Dose administration of the IMP in the evening of Day 2 and morning and evening dose for Days 3 and 4 will be performed at home. The subjects will check-in again in the morning of Day 5 and receive the last dose administration of the IMP and stay in the clinic 12 hours post dose. All subjects within the same cohort will receive the same dose of the IMP. There will be 3 cohorts (dose-levels) with 8 subjects in each cohort corresponding to 24 subjects in total. Within a cohort the subjects will be dosed in groups of 4. There will be 24 hours between the dosing of the groups and 15 minutes between the dosing of the subjects in a group. There will be an interval of approximately at least 1-week interval between the cohorts to allow time for compilation and evaluation of data for the Internal Safety Review Committee meeting. Subsequent cohorts will be administered increasing doses until either the maximum tolerated dose (MTD) or the study maximum dose (SMD) has been reached.

Official Title
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An Open-label, Single Center, Phase I, Dose Escalation Study Investigating the Safety, Tolerability and Pharmacokinetics of Pemirolast in Healthy Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: CRD007


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent, healthy subjects aged 19-65 years Exclusion Criteria: Significant concurrent disease or medical conditions that are deemed to interfere with the safety or pharmacokinetics of CRD007 conduct of the trial

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cohorte 1<br>Low dose pemirolast sodium (CRD007) given as one single dose on day 1, and thereafter twice daily for 3 days, followed by one single dose on day 5 and last day | Drug: CRD007<br> <br> * Other names: Pemirolast;|
| Active Comparator: Cohorte 2<br>Medium dose CRD007 given as one single dose on day 1, and thereafter twice daily for 3 days, followed by one single dose on day 5 and last day | Drug: CRD007<br> <br> * Other names: Pemirolast;|
| Active Comparator: Cohorte 3<br>High dose CRD007 given as one single dose on day 1, and thereafter twice daily for 3 days, followed by one single dose on day 5 and last day | Drug: CRD007<br> <br> * Other names: Pemirolast;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with Adverse Events as a measure of Safety and Tolerability |  | Change from baseline to day 5 (12 hours post dose) | 
| Results of physical examination as a composite outcome measure of Safety and Tolerability |  | Change from baseline to day 5 (12 hours post dose) | 
| ECG recording as a measure of Safety and Tolerability |  | Change from baseline to day 5 (12 hours post dose) | 
| Vital signs (Blood Pressure and Pulse Rate) as a composite outcome measure of Safety and Tolerability |  | Change from baseline to day 5 (2 hours post dose) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite outcome measure consisting of multiple pharmacokinetics measures (Area Under the plasma concentration-time Curve (AUC), Plasma elimination half-life (t½), Time to maximum plasma drug concentration (Tmax), and Peak Plasma Concentration (Cmax)) |  | Blood sampling day 1 up to 24 hrs post dose and day 5 up to 24 hrs post dose |