Randomized, Double-Blind, Placebo-Controlled, MAD Study to Assess the Safety, Tolerability, and Pharmacokinetics of SXC 2023

Study Overview
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Brief Summary
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This is a randomized, double-blind, placebo-controlled, multiple ascending dose study conducted at one study center in the United States. Safety and tolerability will be assessed throughout the study and serial blood samples and urine samples will be collected for the safety and pharmacokinetic assessment of SXC-2023.

Official Title
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A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of SXC 2023 When Administered Orally to Healthy Adult Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: SXC-2023
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, adult, male or female, 18 55 years of age, inclusive, at screening. Continuous non smoker who has not used nicotine containing products for at least 3 months prior to the first dose and throughout the study. BMI ≥ 18.0 and ≤ 32.0 kg/m2 at screening. Medically healthy with no clinically significant screening results. For a female of childbearing potential: either be sexually inactive (abstinent as a life style) for 28 days prior to the first dosing and throughout the study or be using acceptable birth control methods: Female of non childbearing potential: must have undergone sterilization procedures, at least 6 months prior to the first dose Non vasectomized, male subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days beyond the last dose of study drug/placebo. Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol. Exclusion Criteria: Subject is mentally or legally incapacitated History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study. History or presence of alcoholism or drug abuse within the past 2 years History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds. Females with a positive pregnancy test or is lactating. Positive urine cotinine at screening. Positive urine drug or alcohol results at screening Any significant finding on the Columbia Suicidal Severity Rating Scale (C-SSRS) Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV). Unable to refrain from or anticipates the use of any drug (e.g. prescription, recreational, etc.) Donation of blood or significant blood loss within 56 days prior to the first dose. Plasma donation within 7 days prior to the first dose. Participation in another clinical study within 30 days prior to the first dose.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SXC-2023<br>Dose Escalation | Drug: SXC-2023<br>* Oral capsule<br>|
| Placebo Comparator: Placebo<br>Dose Escalation | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment related adverse events | Treatment related adverse events as a measure of safety and tolerability of SXC-2023 following multiple ascending doses | 18 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic Assessments: Cmax | Peak plasma concentration | Up to 96 hr post dose | 
| Pharmacokinetic Assessments: Tmax | Time to peak plasma concentration | Up to 96 hr post dose | 
| Pharmacokinetic Assessments: AUC | Area under the plasma concentration-time curve | Up to 96 hr post dose |