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

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.

Study Overview

• Status: Recruiting
• Conditions: Opioid Use Disorder; Opioid Overdose
• Intervention / Treatment: Biological: Placebo; Biological: CSX-1004

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Brandi Eckard; Phone Number: 913-333-3000; Email: breckard@drvince.com
• Study Contact Backup: Name: Lora Adriano; Phone Number: 913-333-3000; Email: ladriano@drvince.com

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • Recruiting
      • Dr. Vince Clinical Research
      • Contact: Brandi Eckard; Phone Number: 913-333-3000; Email: breckard@drvince.com
      • Contact: Lora Adriano; Phone Number: 913-333-3000; Email: ladriano@drvince.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Sterile saline for injection	Biological: Placebo; Sterile saline for injection
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment-emergent adverse events (AEs), serious AEs, and AEs leading to discontinuation	Incidence, intensity, and causality of adverse events	5 months
Clinical laboratory assessments	Hematology, biochemistry, and urinalysis	5 months
Vital signs	Blood pressure and pulse rate	5 months
12-Lead electrocardiogram	Variables will include ventricular heart rate and the PR, QRS, QT, QTcB and QTcF intervals	5 months
Physical examination	Complete physical examination, assessing the subject's overall health and physical condition	5 months
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum serum concentration	4 months
AUCinf	Area under the curve from time zero extrapolated to infinity	4 months
AUClast	Area under the curve from time zero to the last measurable concentration	4 months
Tmax	Time to maximum serum concentration	4 months
t1/2	beta terminal elimination half-life	4 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cessation Therapeutics, Inc.
• Collaborators: Dr. Vince Clinical Research
• Investigators: Principal Investigator: Steven Hull, MD, Dr. Vince Clinical Research

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: August 4, 2023
• First Submitted That Met QC Criteria: August 17, 2023
• First Posted (Actual): August 22, 2023

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 17, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Drug Overdose; Opioid-Related Disorders; Opiate Overdose
• Other Study ID Numbers: CSX-1004.101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No