Safety, Tolerability, and Pharmacokinetics of CSX-1004
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
| Placebo Comparator: Placebo Sterile saline for injection |
Biological: Placebo
Sterile saline for injection
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 Outcome Measures
- 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
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dr. Vince Clinical Research | Overland Park | Kansas | United States | 66212 |
Sponsors and Collaborators
- Cessation Therapeutics, Inc.
- Dr. Vince Clinical Research
Investigators
- Principal Investigator: Steven Hull, MD, Dr. Vince Clinical Research
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CSX-1004.101