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Safety, Tolerability, and Pharmacokinetics of CSX-1004 | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Safety, Tolerability, and Pharmacokinetics of CSX-1004

A Phase 1a, Randomized, Double-Blind, Placebo-Controlled, Single Site, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of CSX-1004 Injection in Healthy Adults

NCT06005402•Cessation Therapeutics, Inc.

View on ClinicalTrials.gov

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

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Yes

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 Criteria

•Positive UDS for substances of abuse (including alcohol) at Screening or admission to the Treatment Phase
•Current daily cigarette smoker within 3 months of Screening. Social smoking, as defined 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 the opinion of the Investigator, might jeopardize the safety of the subject or the validity of the study results.

Locations (1)

Dr. Vince Clinical Research

Overland Park, Kansas, United States

Key Dates

Start Date

August 1, 2023

Primary Completion Date

May 28, 2024

Completion Date

May 28, 2024

Last Updated

August 21, 2024

Enrollment

ACTUAL participants

Conditions

Opioid OverdoseOpioid Use Disorder

Interventions

CSX-1004

BIOLOGICAL

Placebo

BIOLOGICAL

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NCT06651177

Opioid Use DisorderOpioid Use Disorder, Moderate+1 more

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RECRUITINGNA

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NCT06843213

Opioid Use DisorderHarm Reduction+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 21, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety, Tolerability, and Pharmacokinetics of CSX-1004

Inclusion Criteria

Exclusion Criteria

Evaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder

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OUD (Opioid Use Disorder) Target Trial