Status:
COMPLETED
Safety, Tolerability, and Pharmacokinetics of CSX-1004
Lead Sponsor:
Cessation Therapeutics, Inc.
Collaborating Sponsors:
Dr. Vince Clinical Research
Conditions:
Opioid Overdose
Opioid Use Disorder
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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 rang...
Eligibility Criteria
Inclusion
- Major
- 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
- 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.
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 28 2024
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06005402
Start Date
August 1 2023
End Date
May 28 2024
Last Update
August 21 2024
Active Locations (1)
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1
Dr. Vince Clinical Research
Overland Park, Kansas, United States, 66212