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| Name | Class |
|---|---|
| Dr. Vince Clinical Research | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CSX-1004 | Experimental | Single doses of CSX-1004 Injection |
|
| Placebo | Placebo Comparator | Sterile saline for injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CSX-1004 | Biological | Recombinant human immunoglobulin G (IgG) 1λ monoclonal antibody specific for fentanyl and structurally related fentanyl analogs |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum serum concentration | 4 months |
| AUCinf | Area under the curve from time zero extrapolated to infinity | 4 months |
| 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 |
Major Inclusion Criteria:
Major Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Hull, MD | Dr. Vince Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Vince Clinical Research | Overland Park | Kansas | 66212 | United States |
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| ID | Term |
|---|---|
| D000083682 | Opiate Overdose |
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D062787 | Drug Overdose |
| D063487 | Prescription Drug Misuse |
| D000076064 | Drug Misuse |
| D019966 | Substance-Related Disorders |
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Single ascending dose study
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| Placebo | Biological | Sterile saline for injection |
|
| 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 |
| D064419 |
| Chemically-Induced Disorders |
| D000079524 | Narcotic-Related Disorders |
| D001523 | Mental Disorders |