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CompletedNCT03542435Updated Oct 16, 2018

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

A Phase 1 interventional study of SXC-2023 and Placebo in Healthy Volunteers, sponsored by Promentis Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-16.

Sponsored by Promentis Pharmaceuticals, Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Aug 2018, 8 years 2 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

Promentis Pharmaceuticals, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    SXC-2023

    Dose Escalation

    Drug: SXC-2023

  • Placebo comparator
    Placebo

    Dose Escalation

    Drug: Placebo

Interventions

  • DrugSXC-2023

    Oral capsule

  • DrugPlacebo

    Placebo

06

What researchers measure

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

    Time frame: 18 days

Secondary outcomes

  1. Pharmacokinetic Assessments: Cmax

    Peak plasma concentration

    Time frame: Up to 96 hr post dose

  2. Pharmacokinetic Assessments: Tmax

    Time to peak plasma concentration

    Time frame: Up to 96 hr post dose

  3. Pharmacokinetic Assessments: AUC

    Area under the plasma concentration-time curve

    Time frame: Up to 96 hr post dose

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Study locations

1 site
  • Celerion
    Tempe, Arizona 85283, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 16, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03542435
Lead sponsor
Promentis Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
May 31, 2018
Start date
Apr 26, 2018
Primary completion
Aug 8, 2018
Completion
Sep 10, 2018
Last update
Oct 16, 2018

Study contacts

Tricia Cotter
study director · Promentis Pharmaceuticals, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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