Safety, Tolerability, and Pharmacokinetics of CSX-1004

Phase 1

Completed

• Conditions: Opioid Overdose; Opioid Use Disorder

• Registration Number: NCT06005402
• Lead Sponsor: Cessation Therapeutics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-8-4
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Major Inclusion Criteria:<br><br> - Healthy male or female subjects, aged 18 to 50 years, inclusive,<br><br> - Minimum weight of 50.0 kg and maximum weight of 100.0 kg<br><br> - Body mass index (BMI) within the range of 18.0 to 32.0 kg/m2, inclusive<br><br>Major Exclusion Criteria:<br><br> - Positive UDS for substances of abuse (including alcohol) at Screening or admission<br> to the Treatment Phase<br><br> - Current daily cigarette smoker within 3 months of Screening. Social smoking, as<br> defined by non-daily use of nicotine-containing products, is permitted.<br><br> - History or presence of any clinically significant cardiac, psychiatric, endocrine,<br> hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic,<br> dermatologic, renal, or other major disease or illness at Screening, which in the<br> opinion of the Investigator, might jeopardize the safety of the subject or the<br> validity of the study results.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment-emergent adverse events (AEs), serious AEs, and AEs leading to discontinuation;Clinical laboratory assessments;Vital signs;12-Lead electrocardiogram;Physical examination;Infusion site examination

Secondary Outcome Measures

Name	Time	Method
Cmax;AUCinf;AUClast;Tmax;t1/2