Safety, Tolerability, and Pharmacokinetics of CSX-1004

Cessation Therapeutics

Status and phase: Completed; Phase 1

Conditions: Opioid Overdose; Opioid Use Disorder

Treatments: Biological: CSX-1004; Biological: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06005402

CSX-1004.101

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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32 participants in 2 patient groups, including a placebo group

CSX-1004

Experimental group

Description:

Single doses of CSX-1004 Injection

Treatment:

Biological: CSX-1004

Placebo

Placebo Comparator group

Description:

Sterile saline for injection

Treatment:

Biological: Placebo