Safety, Tolerability, and Pharmacokinetics of CSX-1004

Last updated: August 19, 2024
Sponsor: Cessation Therapeutics, Inc.
Overall Status: Completed

Phase

1

Condition

Opioid Use Disorder

Treatment

Placebo

CSX-1004

Clinical Study ID

NCT06005402
CSX-1004.101
  • Ages 18-50
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This is a Phase 1a, randomized, double-blind, single ascending dose study, designed to assess the safety, tolerability, and PK of a single CSX-1004 injection, administered by IV infusion across a range of doses in healthy adult subjects. The study will have 3 phases: Screening, Inpatient Treatment, and Outpatient Follow-up.

The primary objective of the study is to determine the safety and tolerability of CSX-1004 Injection administered by intravenous (IV) infusion across a range of doses in healthy adult subjects.

The secondary objective of the study is to determine the pharmacokinetics (PK) of CSX-1004 Injection administered by IV infusion across a range of doses in healthy adult subjects.

Eligibility Criteria

Inclusion

Major Inclusion Criteria:

  • Healthy male or female subjects, aged 18 to 50 years, inclusive,

  • Minimum weight of 50.0 kg and maximum weight of 100.0 kg

  • Body mass index (BMI) within the range of 18.0 to 32.0 kg/m2, inclusive

Exclusion

Major Exclusion Criteria:

  • Positive UDS for substances of abuse (including alcohol) at Screening or admissionto the Treatment Phase

  • Current daily cigarette smoker within 3 months of Screening. Social smoking, asdefined by non-daily use of nicotine-containing products, is permitted.

  • History or presence of any clinically significant cardiac, psychiatric, endocrine,hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic,dermatologic, renal, or other major disease or illness at Screening, which in theopinion of the Investigator, might jeopardize the safety of the subject or thevalidity of the study results.

Study Design

Total Participants: 32
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
August 01, 2023
Estimated Completion Date:
May 28, 2024

Connect with a study center

  • Dr. Vince Clinical Research

    Overland Park, Kansas 66212
    United States

    Site Not Available

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