Opioid Use Disorder Clinical Trial
Official title:
A Phase 1a, Randomized, Double-Blind, Placebo-Controlled, Single Site, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of CSX-1004 Injection in Healthy Adults
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.
Status | Recruiting |
Enrollment | 32 |
Est. completion date | May 2024 |
Est. primary completion date | May 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Dr. Vince Clinical Research | Overland Park | Kansas |
Lead Sponsor | Collaborator |
---|---|
Cessation Therapeutics, Inc. | Dr. Vince Clinical Research |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Primary | Treatment-emergent adverse events (AEs), serious AEs, and AEs leading to discontinuation | Incidence, intensity, and causality of adverse events | 5 months | |
Primary | Clinical laboratory assessments | Hematology, biochemistry, and urinalysis | 5 months | |
Primary | Vital signs | Blood pressure and pulse rate | 5 months | |
Primary | 12-Lead electrocardiogram | Variables will include ventricular heart rate and the PR, QRS, QT, QTcB and QTcF intervals | 5 months | |
Primary | Physical examination | Complete physical examination, assessing the subject's overall health and physical condition | 5 months | |
Primary | 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 | Cmax | Maximum serum concentration | 4 months | |
Secondary | AUCinf | Area under the curve from time zero extrapolated to infinity | 4 months | |
Secondary | AUClast | Area under the curve from time zero to the last measurable concentration | 4 months | |
Secondary | Tmax | Time to maximum serum concentration | 4 months | |
Secondary | t1/2 | beta terminal elimination half-life | 4 months |
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