Safety, Tolerability, and Pharmacokinetics of CSX-1004

Opioid Use Disorder Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06005402
• Other study ID #: CSX-1004.101
• Status: Recruiting
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Opiate Overdose
• Opioid Overdose
• Opioid Use Disorder
• Opioid-Related Disorders

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