Safety, Tolerability, and Pharmacokinetics of CSX-1004

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-05-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Opioid Overdose Opioid Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Single ascending dose study

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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CSX-1004

Single doses of CSX-1004 Injection

Group Type EXPERIMENTAL

CSX-1004

Intervention Type BIOLOGICAL

Recombinant human immunoglobulin G (IgG) 1λ monoclonal antibody specific for fentanyl and structurally related fentanyl analogs

Placebo

Sterile saline for injection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Sterile saline for injection

Interventions

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CSX-1004

Recombinant human immunoglobulin G (IgG) 1λ monoclonal antibody specific for fentanyl and structurally related fentanyl analogs

Intervention Type BIOLOGICAL

Placebo

Sterile saline for injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes