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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Placebo; Drug: SXC-2023

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85283
      • Celerion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy, adult, male or female, 18 55 years of age, inclusive, at screening.
2. Continuous non smoker who has not used nicotine containing products for at least 3 months prior to the first dose and throughout the study.
3. BMI ≥ 18.0 and ≤ 32.0 kg/m2 at screening.
4. Medically healthy with no clinically significant screening results.
5. 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:
6. Female of non childbearing potential: must have undergone sterilization procedures, at least 6 months prior to the first dose
7. 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.
8. Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.

Exclusion Criteria:

1. Subject is mentally or legally incapacitated
2. 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.
3. History or presence of alcoholism or drug abuse within the past 2 years
4. History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds.
5. Females with a positive pregnancy test or is lactating.
6. Positive urine cotinine at screening.
7. Positive urine drug or alcohol results at screening
8. Any significant finding on the Columbia Suicidal Severity Rating Scale (C-SSRS)
9. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
10. Unable to refrain from or anticipates the use of any drug (e.g. prescription, recreational, etc.)
11. Donation of blood or significant blood loss within 56 days prior to the first dose.
12. Plasma donation within 7 days prior to the first dose.
13. Participation in another clinical study within 30 days prior to the first dose.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SXC-2023; Dose Escalation	Drug: SXC-2023; Oral capsule
PLACEBO_COMPARATOR: Placebo; Dose Escalation	Drug: Placebo; Placebo

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Promentis Pharmaceuticals, Inc.
• Investigators: Study Director: Tricia Cotter, Promentis Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 26, 2018
• Primary Completion (ACTUAL): August 8, 2018
• Study Completion (ACTUAL): September 10, 2018

Study Registration Dates

• First Submitted: May 18, 2018
• First Submitted That Met QC Criteria: May 30, 2018
• First Posted (ACTUAL): May 31, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 16, 2018
• Last Update Submitted That Met QC Criteria: October 15, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: PRO-104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No