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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: SXC-2023; Drug: Placebo

• Registration Number: NCT03542435
• Lead Sponsor: Promentis Pharmaceuticals, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-26
• Study First Submitted: 2018-05-18
• Study First Submitted QC: 2018-05-30
• Study First Posted: 2018-05-31
• Primary Completion: 2018-08-08
• Study Completion: 2018-09-10
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-15
• Last Update Posted: 2018-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SXC-2023	SXC-2023	Dose Escalation
Placebo	Placebo	Dose Escalation

Primary Outcome Measures

Name	Time	Method
Treatment related adverse events	18 days	Treatment related adverse events as a measure of safety and tolerability of SXC-2023 following multiple ascending doses

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic Assessments: AUC	Up to 96 hr post dose	Area under the plasma concentration-time curve
Pharmacokinetic Assessments: Cmax	Up to 96 hr post dose	Peak plasma concentration
Pharmacokinetic Assessments: Tmax	Up to 96 hr post dose	Time to peak plasma concentration

Trial Locations

Locations (1)

Celerion; 🇺🇸 Tempe, Arizona, United States