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Safety, Tolerability, and Pharmacokinetics of CSX-1004

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06005402
Recruitment Status : Recruiting
First Posted : August 22, 2023
Last Update Posted : August 22, 2023
Sponsor:
Collaborator:
Dr. Vince Clinical Research
Information provided by (Responsible Party):
Cessation Therapeutics, Inc.

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Opioid Overdose Opioid Use Disorder Biological: CSX-1004 Biological: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Single ascending dose study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 1, 2023
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : May 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: CSX-1004
Single doses of CSX-1004 Injection
 Biological: CSX-1004
Recombinant human immunoglobulin G (IgG) 1λ monoclonal antibody specific for fentanyl and structurally related fentanyl analogs
Placebo Comparator: Placebo
Sterile saline for injection
 Biological: Placebo
Sterile saline for injection


Outcome Measures
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Primary Outcome Measures :
  1. Treatment-emergent adverse events (AEs), serious AEs, and AEs leading to discontinuation [ Time Frame: 5 months ]
    Incidence, intensity, and causality of adverse events

  2. Clinical laboratory assessments [ Time Frame: 5 months ]
    Hematology, biochemistry, and urinalysis

  3. Vital signs [ Time Frame: 5 months ]
    Blood pressure and pulse rate

  4. 12-Lead electrocardiogram [ Time Frame: 5 months ]
    Variables will include ventricular heart rate and the PR, QRS, QT, QTcB and QTcF intervals

  5. Physical examination [ Time Frame: 5 months ]
    Complete physical examination, assessing the subject's overall health and physical condition

  6. Infusion site examination [ Time Frame: 6 days ]
    Infusion site will be visually inspected for evidence of erythema, edema, itching, pain, infection, bleeding, abnormal healing, and any other abnormalities


Secondary Outcome Measures :
  1. Cmax [ Time Frame: 4 months ]
    Maximum serum concentration

  2. AUCinf [ Time Frame: 4 months ]
    Area under the curve from time zero extrapolated to infinity

  3. AUClast [ Time Frame: 4 months ]
    Area under the curve from time zero to the last measurable concentration

  4. Tmax [ Time Frame: 4 months ]
    Time to maximum serum concentration

  5. t1/2 [ Time Frame: 4 months ]
    beta terminal elimination half-life


Other Outcome Measures:
  1. Immunogenicity [ Time Frame: 4 months ]
    Proportions of subjects who are positive (above the limits of quantitation) and negative (below the limits of quantitation) for anti-CSX-1004 antibodies


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Major 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06005402


Contacts
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Contact: Brandi Eckard 913-333-3000 breckard@drvince.com
Contact: Lora Adriano 913-333-3000 ladriano@drvince.com

Locations
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United States, Kansas
Dr. Vince Clinical Research Recruiting
Overland Park, Kansas, United States, 66212
Contact: Brandi Eckard    913-333-3000    breckard@drvince.com   
Contact: Lora Adriano    913-333-3000    ladriano@drvince.com   
Sponsors and Collaborators
Cessation Therapeutics, Inc.
Dr. Vince Clinical Research
Investigators
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Principal Investigator: Steven Hull, MD Dr. Vince Clinical Research
More Information
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Responsible Party: Cessation Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT06005402    
Other Study ID Numbers: CSX-1004.101
First Posted: August 22, 2023    Key Record Dates
Last Update Posted: August 22, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Opioid-Related Disorders
Opiate Overdose
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
 Mental Disorders
Drug Overdose
Prescription Drug Misuse
Drug Misuse