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NCT Number: NCT06005402

Safety, Tolerability, and Pharmacokinetics of CSX-1004

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.

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Key information

Conditions

Opioid Overdose Chemically-Induced Disorders Drug Misuse Drug Overdose Mental Disorders Narcotic-Related Disorders Opiate Overdose Opioid Use Disorder Opioid-Related Disorders Prescription Drug Misuse Substance-Related Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Dr. Vince Clinical Research

Overland Park, Kansas, 66212, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CSX-1004

Biological

Recombinant human immunoglobulin G (IgG) 1λ monoclonal antibody specific for fentanyl and structurally related fentanyl analogs

Placebo

Biological

Sterile saline for injection

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Cessation Therapeutics, Inc.

Industry

Collaborators

  • Dr. Vince Clinical Research

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 22, 2023
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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