A Phase 1 interventional study of CSX-1004 and Placebo in Opioid Overdose and Opioid Use Disorder, sponsored by Cessation Therapeutics, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-21.
Sponsored by Cessation Therapeutics, Inc. · Phase 1, Interventional, and Treatment
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.
70 studies on the registry are indexed under Opiate Overdose; 11 are open to participants now.
This study's enrollment of 32 is below the median of 184 across 48 interventional studies indexed under Opiate Overdose.
Browse Opiate Overdose studies →This is the only study on the registry with Cessation Therapeutics, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Major Inclusion Criteria:
Major Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single doses of CSX-1004 Injection
Biological: CSX-1004
Sterile saline for injection
Biological: Placebo
Recombinant human immunoglobulin G (IgG) 1λ monoclonal antibody specific for fentanyl and structurally related fentanyl analogs
Sterile saline for injection
Treatment-emergent adverse events (AEs), serious AEs, and AEs leading to discontinuation
Incidence, intensity, and causality of adverse events
Time frame: 5 months
Clinical laboratory assessments
Hematology, biochemistry, and urinalysis
Time frame: 5 months
Vital signs
Blood pressure and pulse rate
Time frame: 5 months
12-Lead electrocardiogram
Variables will include ventricular heart rate and the PR, QRS, QT, QTcB and QTcF intervals
Time frame: 5 months
Physical examination
Complete physical examination, assessing the subject's overall health and physical condition
Time frame: 5 months
Infusion site examination
Infusion site will be visually inspected for evidence of erythema, edema, itching, pain, infection, bleeding, abnormal healing, and any other abnormalities
Time frame: 6 days
Cmax
Maximum serum concentration
Time frame: 4 months
AUCinf
Area under the curve from time zero extrapolated to infinity
Time frame: 4 months
AUClast
Area under the curve from time zero to the last measurable concentration
Time frame: 4 months
Tmax
Time to maximum serum concentration
Time frame: 4 months
t1/2
beta terminal elimination half-life
Time frame: 4 months
Immunogenicity
Proportions of subjects who are positive (above the limits of quantitation) and negative (below the limits of quantitation) for anti-CSX-1004 antibodies
Time frame: 4 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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