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Safety, Tolerability, and Pharmacokinetics of CSX-1004

NCT06005402 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-08-21

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

CSX-1004

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

BIOLOGICAL

Placebo

Sterile saline for injection

Sponsors & Collaborators

  • Dr. Vince Clinical Research

    collaborator OTHER

  • Cessation Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Steven Hull, MD · Dr. Vince Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2024-05-28
Completion
2024-05-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06005402 on ClinicalTrials.gov