Safety, Tolerability, and Pharmacokinetic Study of CAT-1004 in Healthy Adult Volunteers

Study Overview
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Brief Summary
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To evaluate the safety and tolerability of escalating single doses of CAT-1004 relative to placebo in healthy adult volunteers. To evaluate the pharmacokinetics (PK) of escalating single doses of CAT-1004 in healthy adult volunteers. To evaluate the effect of a high-fat meal on single doses of CAT-1004 in healthy adult volunteers.

Official Title
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A Single Center, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study of CAT-1004 in Healthy Adult Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Drug
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: In good health. Age: 19 to 55 years inclusive at Screening. Satisfies one of the following Females not of childbearing potential: non-pregnant and non-lactating; surgically sterile or postmenopausal, OR Males: surgically sterile, abstinent, or subject or partner is utilizing an acceptable contraceptive method during and 3 months after the last study dose. BMI: 18 to 30 kg/m2 at Screening. Key Exclusion Criteria: Clinically significant abnormalities in physical examination or vital signs. Clinically significant electrocardiogram (ECG) abnormalities as assessed by the investigator. Clinically significant screening laboratory result as assessed by the Investigator. The subject has a history of clinically significant allergies (except for untreated, asymptomatic seasonal allergies at the time of dosing), or hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease. History or presence of malignancy with the past 5 years. History of alcohol or substance abuse or eating disorder within 2 years, OR regular use of alcohol within 6 months (>14 units of alcohol per week; 1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol). Use of any investigational drug or participation in any investigational study within 30 days prior to screening. For dose levels 6 and 7 fed cohorts, subjects may participate who have taken part in the dose levels 4 and 5 fasted cohort. Any significant blood loss within 60 days prior to screening, e.g. blood donation, participation in study with multiple blood draws, etc. Any condition, disease, disorder or clinically relevant laboratory abnormality that, in the opinion of the Investigator, would jeopardize the subject's appropriate participation in this study or obscure the effects of treatment. A suspected allergy or sensitivity to CAT-1004 or excipients based upon known allergies to excipients or compounds of a similar class. Any clinically significant systemic infection within 3 weeks prior to screening. Use of prescription medications within 30 days of screening.

Ages Eligible for Study
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Minimum Age: 19 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1 / Dose level 1<br>Single dose orally: CAT-1004 Dose level 1 or placebo | Drug: Drug<br>* Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.<br>* Other names: CAT-1004;Other: Placebo<br>* Single dose oral administration of CAT1004 or placebo- 2 subjects treated with placebo per cohort.<br>|
| Experimental: Cohort 2 / Dose level 2<br>Single dose orally: CAT-1004 Dose level 2 or placebo | Drug: Drug<br>* Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.<br>* Other names: CAT-1004;Other: Placebo<br>* Single dose oral administration of CAT1004 or placebo- 2 subjects treated with placebo per cohort.<br>|
| Experimental: Cohort 3 /Dose level 3<br>Single dose orally: CAT-1004 Dose level 3 or placebo | Drug: Drug<br>* Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.<br>* Other names: CAT-1004;Other: Placebo<br>* Single dose oral administration of CAT1004 or placebo- 2 subjects treated with placebo per cohort.<br>|
| Experimental: Cohort 4/ Dose level 4<br>Single dose orally: CAT-1004 Dose level 4 or placebo | Drug: Drug<br>* Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.<br>* Other names: CAT-1004;Other: Placebo<br>* Single dose oral administration of CAT1004 or placebo- 2 subjects treated with placebo per cohort.<br>|
| Experimental: Cohort 5/ Dose level 5<br>Single dose orally: CAT-1004 Dose level 5 or placebo | Drug: Drug<br>* Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.<br>* Other names: CAT-1004;Other: Placebo<br>* Single dose oral administration of CAT1004 or placebo- 2 subjects treated with placebo per cohort.<br>|
| Experimental: Cohort 2/ Dose level 2 ( FE)<br>Single dose orally (Under fed conditions): CAT-1004 Dose level 2 or placebo | Drug: Drug<br>* Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.<br>* Other names: CAT-1004;Other: Placebo<br>* Single dose oral administration of CAT1004 or placebo- 2 subjects treated with placebo per cohort.<br>|
| Experimental: Cohort 3/ Dose level 3 (FE)<br>Single dose orally (Under fed conditions): CAT-1004 Dose level 3 or placebo | Drug: Drug<br>* Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.<br>* Other names: CAT-1004;Other: Placebo<br>* Single dose oral administration of CAT1004 or placebo- 2 subjects treated with placebo per cohort.<br>|
| Experimental: Cohort 6 / Dose level 6 (FE)<br>Single dose orally (Under fed conditions) CAT-1004 Dose level 4 or placebo Subjects may be reenrolled from Cohort 4. | Drug: Drug<br>* Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.<br>* Other names: CAT-1004;Other: Placebo<br>* Single dose oral administration of CAT1004 or placebo- 2 subjects treated with placebo per cohort.<br>|
| Experimental: Cohort 7 / Dose level 7 (FE)<br>Single dose orally (Under fed conditions)CAT-1004 Dose level 5 or placebo Subjects may be reenrolled from Cohort 5. | Drug: Drug<br>* Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.<br>* Other names: CAT-1004;Other: Placebo<br>* Single dose oral administration of CAT1004 or placebo- 2 subjects treated with placebo per cohort.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Safety Endpoints: Laboratory evaluations including hematology, chemistry, coagulation and urinalysis, physical examinations, AEs, serious AEs (SAEs), ECGs, and vital signs. | Change from Baseline versus Day-1 though 72 hrs post dose and EOT/FU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic Profile | The following noncompartmental PK parameters will be calculated: area under the concentration-time curve from time 0 extrapolated to infinity (AUCinf), area under concentration-time curve from time 0 to time of last quantifiable concentration (AUClast), maximum observed plasma concentration (Cmax), time to first occurrence of Cmax (Tmax), terminal phase elimination half-life (t½), apparent oral clearance (CL/F), and volume of distribution during the terminal phase (Vz/F). Additional PK parameters may be calculated if deemed appropriate. | Plasma blood samples through 72 hrs, urine collections through 48 hrs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human healthy volunteers