Safety, Tolerability, and Pharmacokinetics of CSX-1004

Phase 1

Completed

• Conditions: Opioid Overdose; Opioid Use Disorder
• Interventions: Biological: Placebo; Biological: CSX-1004

• Registration Number: NCT06005402
• Lead Sponsor: Cessation Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-01
• Study First Submitted: 2023-08-04
• Study First Submitted QC: 2023-08-17
• Study First Posted: 2023-08-22
• Primary Completion: 2024-05-28
• Study Completion: 2024-05-28
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Sterile saline for injection
CSX-1004	CSX-1004	Single doses of CSX-1004 Injection

Primary Outcome Measures

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

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

Trial Locations

Locations (1)

Dr. Vince Clinical Research; 🇺🇸 Overland Park, Kansas, United States