Opioid OverdosePhase 1NCT06005402
Safety, Tolerability, and Pharmacokinetics of CSX-1004
A Phase 1 study testing CSX-1004 in people with Opioid Overdose and Opioid Use Disorder, run by Cessation Therapeutics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Overdose, Opioid Use Disorder
- What is being tested?
- CSX-1004
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 28 May 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
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 locations and contacts
1 site in 1 country.
United States1 site
Dr. Vince Clinical Research
Overland Park, Kansas, 66212
About this study
Official title: A Phase 1a, Randomized, Double-Blind, Placebo-Controlled, Single Site, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of CSX-1004 Injection in Healthy Adults
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
- Opioid Overdose, Opioid Use Disorder
- Being tested
- CSX-1004, Placebo
- Medical subject headings
- Opiate Overdose, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSX-1004Biological
Recombinant human immunoglobulin G (IgG) 1λ monoclonal antibody specific for fentanyl and structurally related fentanyl analogs
PlaceboBiological
Sterile saline for injection
| Study group | Role | What they receive |
|---|---|---|
| CSX-1004 | Experimental | Single doses of CSX-1004 Injection Receives: Biological: CSX-1004 |
| Placebo | Placebo comparator | Sterile saline for injection Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent adverse events (AEs), serious AEs, and AEs leading to discontinuation
Incidence, intensity, and causality of adverse events
Measured: 5 months
Clinical laboratory assessments
Hematology, biochemistry, and urinalysis
Measured: 5 months
Vital signs
Blood pressure and pulse rate
Measured: 5 months
12-Lead electrocardiogram
Variables will include ventricular heart rate and the PR, QRS, QT, QTcB and QTcF intervals
Measured: 5 months
Physical examination
Complete physical examination, assessing the subject's overall health and physical condition
Measured: 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
Measured: 6 days
Secondary outcomes (5)
Cmax
Maximum serum concentration
Measured: 4 months
AUCinf
Area under the curve from time zero extrapolated to infinity
Measured: 4 months
AUClast
Area under the curve from time zero to the last measurable concentration
Measured: 4 months
Tmax
Time to maximum serum concentration
Measured: 4 months
t1/2
beta terminal elimination half-life
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start1 Aug 2023
- Primary completion28 May 2024
- Study completion28 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid OverdoseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Single ascending dose study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cessation Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dr. Vince Clinical Research
- Responsible party
- Sponsor
- Investigators
- Steven Hull, MD, Principal investigator, Dr. Vince Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005402
- Sponsor's protocol ID
- CSX-1004.101
- Status last verified
- Aug 2024
- First submitted
- 4 Aug 2023
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a, Randomized, Double-Blind, Placebo-Controlled, Single Site, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of CSX-1004 Injection in Healthy Adults
- ClinicalTrials.gov ID
- NCT06005402
- Acronym / sponsor ID
- CSX-1004.101
- Conditions
- Opioid Overdose, Opioid Use Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Cessation Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Dr. Vince Clinical Research
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 28 May 2024 (actual)
- Study completion
- 28 May 2024 (actual)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single ascending dose study
| Arm | Type | Receives |
|---|---|---|
| CSX-1004 | Experimental | Biological: CSX-1004Single doses of CSX-1004 Injection |
| Placebo | Placebo comparator | Biological: PlaceboSterile saline for injection |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CSX-1004Recombinant human immunoglobulin G (IgG) 1λ monoclonal antibody specific for fentanyl and structurally related fentanyl analogs | Biological | CSX-1004 |
| PlaceboSterile saline for injection | Biological | Placebo |
Primary outcome
Treatment-emergent adverse events (AEs), serious AEs, and AEs leading to discontinuation
Time frame: 5 months
Incidence, intensity, and causality of adverse events
Clinical laboratory assessments
Time frame: 5 months
Hematology, biochemistry, and urinalysis
Vital signs
Time frame: 5 months
Blood pressure and pulse rate
12-Lead electrocardiogram
Time frame: 5 months
Variables will include ventricular heart rate and the PR, QRS, QT, QTcB and QTcF intervals
Physical examination
Time frame: 5 months
Complete physical examination, assessing the subject's overall health and physical condition
Infusion site examination
Time frame: 6 days
Infusion site will be visually inspected for evidence of erythema, edema, itching, pain, infection, bleeding, abnormal healing, and any other abnormalities
5 secondary outcomes
Cmax
Time frame: 4 months
AUCinf
Time frame: 4 months
AUClast
Time frame: 4 months
Tmax
Time frame: 4 months
t1/2
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Hull, MD principal investigator
Dr. Vince Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CSX-1004 in people with Opioid Overdose and Opioid Use Disorder, run by Cessation Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-emergent adverse events (AEs), serious AEs, and AEs leading to discontinuation (time frame: 5 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.