Safety, Tolerability, and Pharmacokinetics of CSX-1004

NCT06005402 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: CSX-1004.101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Overdose; Opioid Use Disorder

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• Cmax

  4 months

• AUCinf

  4 months

• AUClast

  4 months

• Tmax

  4 months

• t1/2

  4 months

Other Outcomes (1)

• Immunogenicity

  4 months

Study Arms (2)

CSX-1004

EXPERIMENTAL

Single doses of CSX-1004 Injection

Biological: CSX-1004

Placebo

PLACEBO COMPARATOR

Sterile saline for injection

Biological: Placebo

Interventions

CSX-1004 BIOLOGICAL

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

CSX-1004

Placebo BIOLOGICAL

Sterile saline for injection

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cessation Therapeutics, Inc.: lead
• Dr. Vince Clinical Research: collaborator

Study Sites (1)

Dr. Vince Clinical Research

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Conditions

Opiate Overdose; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Drug Overdose; Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Narcotic-Related Disorders; Mental Disorders

Study Officials

• Steven Hull, MD

  Dr. Vince Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single ascending dose study

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 22, 2023
• Study Start: August 1, 2023
• Primary Completion: May 28, 2024
• Study Completion: May 28, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)