HealthyPhase 1NCT05027451
Safety, Tolerability, and Pharmacokinetics of IXT-m200
A Phase 1 study testing IXT-m200 in people with Healthy, run by InterveXion Therapeutics, LLC at 1 site in United States.
Trial summary
Approximately 9 participants will be enrolled in the study in a single cohort. Participants will be randomized to 3 g IXT-m200 or placebo at 7:2. Each will receive their dose as a 30-min intravenous infusion, then remain at the study site overnight to complete Day 1 and Day 2 assessments (e.g., electrocardiogram… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- IXT-m200
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2021to 18 Mar 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -
- Eligible participants will:
- Be 18-65 years of age, inclusive, at the time of study consent;
- Be able and willing to read, comprehend, and give Authorization for Use/Disclosure of Health Information (HIPAA) and informed consent;
- Be healthy, based on the pre-study medical evaluation (medical history and physical exam, vital signs, ECG, and clinical laboratory evaluations);
- Be willing to comply with study instructions and dosing, agree to make all appointments, and complete the entire course of the study;
- Be of nonchildbearing potential or agree to use protocol-specified method(s) of birth control throughout study participation;
- Agree to adhere to Lifestyle Considerations throughout study duration.
Who cannot join
- -
- Eligible participants will NOT:
- Have a history of treatment with a monoclonal antibody in the past year;
- Have a known contraindication or sensitivity to IXT-m200 based on known allergies to other mAbs, any inactive ingredient of IXT-m200, or any other products required for the study procedures;
- Have a history of alcohol and/or drug use disorder, as determined by DSM-5 criteria;
- Have a history of stimulant use, including methamphetamine and amphetamine;
Show all 18Show fewer
- Be currently taking certain other drugs and medications, including: "designer drugs" (e.g., 3,4-methylenedioxyMETH (MDMA, Ecstasy, Adam, XTC) and its N-dimethyl metabolite methylenedioxyamphetamine (MDA), anti-orexigenic drugs (including over-the-counter medications for weight loss), or be chronic users of phenethylamine compounds (e.g., phenylpropanolamine, ephedrine, pseudoephedrine, amphetamine, phentermine, phenmetrazine, methylphenidate, diethylpropion, and propylhexedrine);
- Have a positive drug screen for any psychoactive substances (legal or nonlegal) on Day 1 prior to dosing;
- Have a history of severe allergy (rash, hives, breathing difficulty, etc) to any medications;
- Have a history of allergic or environmental bronchial asthma within the past 3 years;
- Have a clinically significant history of or current abnormality or disease of any organ system, including renal, hepatic, gastrointestinal, cardiovascular, pulmonary (including chronic asthma), endocrine (eg, diabetes), central nervous (eg psychiatric conditions), or hematologic systems, or recent clinically significant surgery;
- Have a history of seizure, epilepsy, severe head injury, multiple sclerosis, or other known neurological conditions;
- Have a planned or scheduled surgical procedure during the study;
- Have recently donated blood or plasma (within 30 days of study drug dose);
- Have a current diagnosis of anorexia nervosa or bulimia disorder;
- Be currently participating or has participated within the last 30 days prior to the start of this study in a drug, device, or other interventional research study;
- Be pregnant or lactating;
- In the Investigator's or Sponsor's (or designee) opinion, be inappropriate for the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinilabs Drug Development Corporation
Eatontown, New Jersey, 07724
About this study
Official title: A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Single-Dose Intravenous Study to Evaluate the Safety and Pharmacokinetics of IXT-m200 in Healthy Participants
Approximately 9 participants will be enrolled in the study in a single cohort. Participants will be randomized to 3 g IXT-m200 or placebo at 7:2. Each will receive their dose as a 30-min intravenous infusion, then remain at the study site overnight to complete Day 1 and Day 2 assessments (e.g., electrocardiogram (ECG), laboratory assessments, blood draws, and vital signs). Following discharge on Day 2, participants will return to the clinic for follow-up pharmacokinetic (PK) and safety assessments on Day 8, then every 1-3 weeks thereafter until Day 127.
- Conditions
- Healthy
- Being tested
- IXT-m200, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IXT-m200Drug
Also called ch-mAb7F9
Anti-methamphetamine chimeric monoclonal antibody (mAb)
PlaceboOther
Normal saline
| Study group | Role | What they receive |
|---|---|---|
| IXT-m200 | Experimental | 3 g of IXT-m200 given once by 30-min intravenous infusion Receives: Drug: IXT-m200 |
| Placebo | Placebo comparator | Normal saline Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-related Adverse Events (AEs) Assessed by Physical Examinations
Physical examinations
Measured: 127 days
Number of Participants With Treatment-related AEs Assessed by Vital Signs
Blood pressure, heart rate, and temperature
Measured: 127 days
Number of Participants With Treatment-related AEs Assessed by ECG
Electrocardiogram
Measured: 30 min post-dose completion
Number of Participants With Treatment-related AEs Assessed by Clinical Laboratory Testing
Clinical laboratory testing
Measured: 64 days
Secondary outcomes (1)
Time Course of IXT-m200 Concentrations
IXT-m200 concentrations over time
Measured: 127 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start25 Oct 2021
- Primary completion18 Mar 2022
- Study completion18 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- InterveXion Therapeutics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study director, InterveXion Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05027451
- Sponsor's protocol ID
- M200C-2102
- Other IDs
- U01DA045366
- Status last verified
- May 2023
- First submitted
- 24 Aug 2021
- Last updated
- 1 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Final datasets are expected to contain pharmacokinetic data on IXT-m200 and safety data. No individually identifiable private information will be distributed.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Single-Dose Intravenous Study to Evaluate the Safety and Pharmacokinetics of IXT-m200 in Healthy Participants
- ClinicalTrials.gov ID
- NCT05027451
- Acronym / sponsor ID
- M200C-2102
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- InterveXion Therapeutics, LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 18 Mar 2022 (actual)
- Study completion
- 18 Mar 2022 (actual)
- First posted
- 30 Aug 2021 (actual)
- Results
- Posted 1 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Approximately 9 participants will be enrolled in the study in a single cohort. Participants will be randomized to 3 g IXT-m200 or placebo at 7:2. Each will receive their dose as a 30-min intravenous infusion, then remain at the study site overnight to complete Day 1 and Day 2 assessments (e.g., electrocardiogram (ECG), laboratory assessments, blood draws, and vital signs). Following discharge on Day 2, participants will return to the clinic for follow-up pharmacokinetic (PK) and safety assessments on Day 8, then every 1-3 weeks thereafter until Day 127.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IXT-m200 | Experimental | Drug: IXT-m2003 g of IXT-m200 given once by 30-min intravenous infusion |
| Placebo | Placebo comparator | Other: PlaceboNormal saline |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- -
- Be 18-65 years of age, inclusive, at the time of study consent;
- Be able and willing to read, comprehend, and give Authorization for Use/Disclosure of Health Information (HIPAA) and informed consent;
- Be healthy, based on the pre-study medical evaluation (medical history and physical exam, vital signs, ECG, and clinical laboratory evaluations);
- Be willing to comply with study instructions and dosing, agree to make all appointments, and complete the entire course of the study;
Key exclusion criteria (18 listed)
- -
- Have a history of treatment with a monoclonal antibody in the past year;
- Have a known contraindication or sensitivity to IXT-m200 based on known allergies to other mAbs, any inactive ingredient of IXT-m200, or any other products required for the study procedures;
- Have a history of alcohol and/or drug use disorder, as determined by DSM-5 criteria;
- Have a history of stimulant use, including methamphetamine and amphetamine;
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 |
|---|---|---|
| IXT-m200Also: ch-mAb7F9Anti-methamphetamine chimeric monoclonal antibody (mAb) | Drug | IXT-m200 |
| PlaceboNormal saline | Other | Placebo |
Primary outcome
Number of Participants With Treatment-related Adverse Events (AEs) Assessed by Physical Examinations
Time frame: 127 days
Physical examinations
Number of Participants With Treatment-related AEs Assessed by Vital Signs
Time frame: 127 days
Blood pressure, heart rate, and temperature
Number of Participants With Treatment-related AEs Assessed by ECG
Time frame: 30 min post-dose completion
Electrocardiogram
Number of Participants With Treatment-related AEs Assessed by Clinical Laboratory Testing
Time frame: 64 days
Clinical laboratory testing
1 secondary outcome
Time Course of IXT-m200 Concentrations
Time frame: 127 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Final datasets are expected to contain pharmacokinetic data on IXT-m200 and safety data. No individually identifiable private information will be distributed.
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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.
Chief Medical Officer study director
InterveXion Therapeutics
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 IXT-m200 in people with Healthy, run by InterveXion Therapeutics, LLC 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?
The sponsor lists 8 inclusion and 18 exclusion criteria. 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 1 Jun 2023. 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?
Yes. Results are posted in the registry (first posted 1 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Treatment-related Adverse Events (AEs) Assessed by Physical Examinations (time frame: 127 days). The study lists 4 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 1 Jun 2023.