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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT03542435

Run by

Promentis Pharmaceuticals, Inc.

People needed

40

Starts

2018-04-26

Expected to finish

2018-09-10

Last updated by the study team

2018-10-16

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Celerion — Tempe, Arizona, United States

Full record on ClinicalTrials.gov

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