Study of COR388 HCl in Healthy Subjects

Study Overview
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Brief Summary
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The study is a randomized, double-blind, placebo-controlled, dose escalation, first-in-human trial of the safety and tolerability of COR388 HCl in healthy male and female subjects.

Official Title
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A Phase 1 Single Ascending Dose Study of COR388 HCl

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: COR388
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Major Inclusion Criteria: Males of reproductive potential must agree to use double-barrier contraceptive measures or avoid intercourse from Day -1 through 28 days after the dose of study drug; Females of child-bearing potential must be non-lactating, have negative serum pregnancy test results at screening visit and Day 1; agree to use double-barrier contraceptive measures or avoid intercourse from Day -10 through 28 days after the dose of study drug; Body mass index (BMI) ≥19 to ≤32 kg/m2; Good health as determined by the absence of clinically significant deviation from normal, by medical history, physical examination, laboratory reports, and 12-lead electrocardiogram (ECG) prior to enrollment; Non-smoker and non-tobacco user for a minimum of 3 months prior to screening and for the duration of the study; Able to understand and willing to comply with all study requirements, and follow the study medication regimen. Major Exclusion Criteria: History or current evidence of cardiac, hepatic, renal, pulmonary, endocrine, neurologic, gastrointestinal, hematologic, oncologic, infectious, or psychiatric disease as determined by screening history, physical examination, laboratory reports, or 12-lead ECG; Need for any concomitant medication (with the exception of hormonal contraceptives as allowed for females of child-bearing potential); Use of any prescription drug within 14 days prior to the first dose of the study (with the exception of hormonal contraceptives for females of childbearing potential); Use of any non-prescription drug and/or herbal supplements within 7 days prior to the first dose of the study; History of significant allergic reaction to any drug; Participation in another investigational new drug research study within the 30 days prior to the first dose of the study; History of alcohol or drug abuse or dependence within 12 months of screening as determined by the Investigator; Positive urine screen for prohibited drugs or positive alcohol screen on Day -1.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Administered as oral capsule<br>|
| Active Comparator: COR388 TBD mg<br> | Drug: COR388<br>* Administered as oral capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration curve (AUC) | Analysis of AUC | 72 hours | 
| Maximum observed plasma concentration (Cmax) | Analysis of Cmax | 72 hours | 
| Time of the first occurrence of the maximum observed plasma concentration (Tmax) | Analysis of Tmax | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment emergent adverse events | Assessment of the incidence and severity of treatment-emergent adverse events. | 72 Hours | 
| Changes in chemistry lab measures (Sodium [Na], Blood Urea Nitrogen [BUN], Calcium [Ca], Total bilirubin). | Assessment of changes in serum chemistry measures. | 72 hours | 
| Changes in hematology lab measures (RBC, Hgb, Hct). | Assessment of changes in hematology measures. | 72 hours | 
| Changes in urinalysis lab parameters (pH, specific gravity, glucose). | Assessment of changes in urinalysis parameters. | 72 hours |