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

NCT03542435 | Completed Phase 1 FDA Drug

• 1 other identifier: PRO-104
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pharmacokinetic Assessments: Cmax

  Up to 96 hr post dose

• Pharmacokinetic Assessments: Tmax

  Up to 96 hr post dose

• Pharmacokinetic Assessments: AUC

  Up to 96 hr post dose

Study Arms (2)

SXC-2023

EXPERIMENTAL

Dose Escalation

Drug: SXC-2023

Placebo

PLACEBO COMPARATOR

Dose Escalation

Drug: Placebo

Interventions

SXC-2023 DRUG

Oral capsule

SXC-2023

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Promentis Pharmaceuticals, Inc.: lead

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

Study Officials

• Tricia Cotter

  Promentis Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: May 31, 2018
• Study Start: April 26, 2018
• Primary Completion: August 8, 2018
• Study Completion: September 10, 2018
• Last Updated: October 16, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)