Clinical trial NCT06005402: Safety, Tolerability, and Pharmacokinetics of CSX-1004
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Opioid Overdose
Opioid Use Disorder
Lead sponsor: Cessation Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Dr. Vince Clinical Research
First posted: 2023-08-22
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Single ascending dose study
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Treatment-emergent adverse events (AEs), serious AEs, and AEs leading to discontinuation
timeFrame: 5 months
measure: Clinical laboratory assessments
timeFrame: 5 months
measure: Vital signs
timeFrame: 5 months
measure: 12-Lead electrocardiogram
timeFrame: 5 months
measure: Physical examination
timeFrame: 5 months
measure: Infusion site examination
timeFrame: 6 days
Secondary outcomes:
measure: Cmax
timeFrame: 4 months
measure: AUCinf
timeFrame: 4 months
measure: AUClast
timeFrame: 4 months
measure: Tmax
timeFrame: 4 months
measure: t1/2
timeFrame: 4 months
Other outcomes:
measure: Immunogenicity
timeFrame: 4 months
Locations:
city: Overland Park
country: United States
facility: Dr. Vince Clinical Research
state: Kansas
Study officials:
affiliation: Dr. Vince Clinical Research
name: Steven Hull, MD
role: PRINCIPAL_INVESTIGATOR
References: