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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06005402
Other study ID # CSX-1004.101
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date August 1, 2023
Est. completion date May 2024

Study information

Verified date August 2023
Source Cessation Therapeutics, Inc.
Contact Brandi Eckard
Phone 913-333-3000
Email breckard@drvince.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 32
Est. completion date May 2024
Est. primary completion date May 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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.

Study Design


Intervention

Biological:
CSX-1004
Recombinant human immunoglobulin G (IgG) 1? monoclonal antibody specific for fentanyl and structurally related fentanyl analogs
Placebo
Sterile saline for injection

Locations

Country Name City State
United States Dr. Vince Clinical Research Overland Park Kansas

Sponsors (2)

Lead Sponsor Collaborator
Cessation Therapeutics, Inc. Dr. Vince Clinical Research

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Immunogenicity Proportions of subjects who are positive (above the limits of quantitation) and negative (below the limits of quantitation) for anti-CSX-1004 antibodies 4 months
Primary Treatment-emergent adverse events (AEs), serious AEs, and AEs leading to discontinuation Incidence, intensity, and causality of adverse events 5 months
Primary Clinical laboratory assessments Hematology, biochemistry, and urinalysis 5 months
Primary Vital signs Blood pressure and pulse rate 5 months
Primary 12-Lead electrocardiogram Variables will include ventricular heart rate and the PR, QRS, QT, QTcB and QTcF intervals 5 months
Primary Physical examination Complete physical examination, assessing the subject's overall health and physical condition 5 months
Primary Infusion site examination Infusion site will be visually inspected for evidence of erythema, edema, itching, pain, infection, bleeding, abnormal healing, and any other abnormalities 6 days
Secondary Cmax Maximum serum concentration 4 months
Secondary AUCinf Area under the curve from time zero extrapolated to infinity 4 months
Secondary AUClast Area under the curve from time zero to the last measurable concentration 4 months
Secondary Tmax Time to maximum serum concentration 4 months
Secondary t1/2 beta terminal elimination half-life 4 months
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