Opioid Overdose, Opioid Use Disorder
Conditions
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.
Interventions
BIOLOGICALCSX-1004
Recombinant human immunoglobulin G (IgG) 1λ monoclonal antibody specific for fentanyl and structurally related fentanyl analogs
BIOLOGICALPlacebo
Sterile saline for injection
Sponsors
Dr. Vince Clinical Research
Cessation Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Single ascending dose study
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | 4 months | Maximum serum concentration |
| AUCinf | 4 months | Area under the curve from time zero extrapolated to infinity |
| AUClast | 4 months | Area under the curve from time zero to the last measurable concentration |
| Tmax | 4 months | Time to maximum serum concentration |
| t1/2 | 4 months | beta terminal elimination half-life |
Other
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity | 4 months | Proportions of subjects who are positive (above the limits of quantitation) and negative (below the limits of quantitation) for anti-CSX-1004 antibodies |
Countries
United States
Outcome results
None listed