Methamphetamine AbusePhase 1NCT01603147
Safety Study of Ch-mAb7F9 for Methamphetamine Abuse
A Phase 1 study testing normal saline and ch-mAb7f9 in people with Methamphetamine Abuse, run by InterveXion Therapeutics, LLC at 1 site in United States.
Trial summary
The primary objective is to determine the safety and tolerability of single, ascending intravenous doses of ch-mAb7F9 in healthy subjects via physical examinations and adverse event, vital sign, electrocardiogram (ECG), and clinical laboratory testing.Phase 1a, randomized, placebo-controlled, first-in-human (FIH)… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Methamphetamine Abuse
- What is being tested?
- normal saline and ch-mAb7f9
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Jul 2013
- 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
Who may be able to join
- Subjects with the following criteria may be considered for inclusion in the study:
- Subject voluntarily agrees to participate in this study and signs an IRB-approved informed consent form prior to performing any of the screening procedures.
- Healthy, determined by the PI based on pre-study medical evaluation (medical history and physical examination, vital signs, ECG, and clinical laboratory evaluations).
- Males or females between 18 to 50 years of age, inclusive.
- The following applies to female subjects:
- Nonchildbearing potential (surgically sterile [hysterectomy, bilateral oophorectomy, or bilateral tubal ligation/occlusion] or post-menopausal 1 year with follicle stimulating hormone [FSH] > 40 U/L).
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- OR
- Nonpregnant, nonlactating females of childbearing age who agree to use medically acceptable forms of birth control (oral contraceptive pills; contraceptive patches; vaginal ring; diaphragm, sponge, or condom with spermicide; hormone injection; or intrauterine device) from screening to end of study follow-up, or whose partner has had a vasectomy.
- The following applies to male subjects:
- Need to have had a vasectomy or agree to use a condom and spermicide in addition to their female partners using a form of birth control.
- Agree not to donate sperm for 90 days post dose.
- Body mass index (BMI) between 18.5 and 30.5 kg/m2, inclusive, at screening. Body weight ≥ 50 kg and ≤ 100 kg at screening.
- Nonsmokers or light smokers (< 10 cigarettes per day) able to refrain from smoking during the in-house period.
Who cannot join
- Subjects presenting with any of the following will not be included in the study:
- A history of treatment with a monoclonal antibody in the past year,
- likely allergy or sensitivity to ch-mAb7F9 based on known allergies to other mAbs, or which, in the opinion of the Principal Investigator (PI), suggests an increased potential for an adverse hypersensitivity to ch-mAb7F9,
- a history of severe allergy (rash, hives, breathing difficulty, etc.) to any medications, either prescription or nonprescription, including dietary supplements or herbal medications,
- a history of allergic or environmental bronchial asthma,
- 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, or hematologic systems, or recent clinically significant surgery,
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- a history of seizure, epilepsy, severe head injury in the opinion of the PI, multiple sclerosis, or other known neurological conditions,
- abnormal pre-admission vital signs, physical examination, clinical laboratory, or any safety variable which is considered clinically significant for this population by the PI or Sponsor (or designee), (volunteers who have or are suspected to have Gilbert's syndrome will be discussed on a case by case basis by the PI, Medical Monitor, and Sponsor),
- a planned or scheduled surgical procedure during the study,
- a clinically significant mental or physical illness within 1 year prior to the first dose, including a history of alcohol and/or drug abuse (DSM IV criteria) within 1 year prior to the first dose of study medication,
- any history of stimulant use or abuse, including methamphetamine, amphetamine, or MDMA (ecstasy),
- a recent (within 30 days of the first dose of study medication) donation of plasma or blood,
- treatment with any medications, either prescription or nonprescription, including dietary supplements or herbal medications, within 14 days prior to the first dose of study medication (exceptions are nonprescription topical medications that are not systemically absorbed, acetaminophen, or vitamins at recommended daily doses),
- ingestion of any known hepatic or renal clearance altering agents (e.g., erythromycin, cimetidine, barbiturates, phenothiazines, St. John's Wort, etc.) within a period of 90 days prior to the first dose of study medication,
- ingestion of any approved prescription anti-obesity drug or taken any over-the-counter medication for weight loss within a period of 90 days prior to the first dose of study medication,
- ingestion or use of any investigational medication or device within 30 days prior to the first dose of study medication; ingestion or use of any investigational anti-obesity medication is prohibited within 3 months prior to the first dose of study medication,
- acute illness within 5 days prior to the first dose of study medication, e.g., flu syndrome, gastrointestinal (GI) virus, or clinically significant indigestion (e.g., reflux) based on the discretion of the PI,
- a positive test for HBsAG, Hepatitis C antibody, Hepatitis A IgM, or Human Immunodeficiency Virus (HIV) Viral Serology tests at the screening visit,
- a positive urine alcohol test at screening or on Day -1; positive urine drug test for illicit substances (amphetamines, barbiturates, benzodiazepines, cocaine, opiates, tetrahydrocannabinol [THC], phencyclidine, propoxyphene or MDMA) at screening or Day -1.
- limited mental capacity to the extent that the subject cannot provide legal consent or understand information regarding the study,
- a requirement for a special diet other than vegetarian or has a significant food allergy or intolerance,
- any subject judged by the PI or Sponsor (or designee) to be inappropriate for the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Quintiles Phase 1 Services
Overland Park, Kansas, 66211
About this study
Official title: A Phase Ia, Double-blind, Randomized, Placebo-controlled, Ascending IV Single-dose Study to Evaluate the Safety and Pharmacokinetics of ch mAb7F9 in Healthy Subjects
The primary objective is to determine the safety and tolerability of single, ascending intravenous doses of ch-mAb7F9 in healthy subjects via physical examinations and adverse event, vital sign, electrocardiogram (ECG), and clinical laboratory testing.Phase 1a, randomized, placebo-controlled, first-in-human (FIH) study of intravenously administered ch-mAb7F9. The study will be a double-blind, dose-escalation study. Each subject will receive a single dose of ch-mAb7F9 or placebo (saline).
Read the detailed description
There will be 5 dose groups. At the beginning of dosing in each group, 1 subject will receive the normal saline placebo and 1 will receive the active dose. The remainder of the dose group will receive their doses beginning 48 hr later, after safety evaluations. Dosing of the remaining subjects in each dose group will occur 1 at a time, with dosing in each subsequent subject separated by a minimum of 24 hr. Subsequent dose groups will receive their doses beginning approximately 2 weeks after dosing in the preceding group, pending safety analyses.
The single doses to be administered in each cohort are 0.2, 0.6, 2, 6, and 20 mg/kg, respectively. The starting dose will be 0.2 mg/kg, and the highest dose will be 20 mg/kg (up to a maximum of 1,500 mg), which is at least 20-fold lower than the no observable adverse effect level (NOAEL) in rats to ensure subject safety.
Ch-mAb7F9 will be administered intravenously (IV) with a saline flush to clear the administration tubing of residual ch-mAb7F9. Each dose of ch-mAb7F9 will be diluted in 225 ml of saline and given over two hours.
- Conditions
- Methamphetamine Abuse
- Being tested
- normal saline, ch-mAb7f9
- Keywords
- methamphetamine, monoclonal antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal salineBiological
saline 225 ml
ch-mAb7f9Biological
The single doses to be administered in each cohort are 0.2, 0.6, 2, 6, and 20 mg/kg, respectively. Volume to be administered 225 ml
| Study group | Role | What they receive |
|---|---|---|
| Saline | Placebo comparator | A total of 10 subjects will receive placebo Receives: Biological: normal saline |
| ch-mAb7F9 | Experimental | The single doses to be administered in each cohort are 0.2, 0.6, 2, 6, and 20 mg/kg, respectively. Receives: Biological: ch-mAb7f9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
The primary outcome is to determine the safety and tolerability of single, ascending intravenous doses of ch-mAb7F9 in healthy subjects via physical examinations and adverse event, vital sign, electrocardiogram (ECG), and clinical laboratory testing.
Measured: 21 weeks
Secondary outcomes (2)
Pharmacokinetics
A secondary outcome is to characterize the pharmacokinetics of ch-mAb7F9 following single, ascending intravenous doses of ch-mAb7F9 in healthy subjects by measurement of mAb serum concentrations
Measured: 21 weeks
Immunogenicity
A secondary outcome is to characterize the immune response following single, ascending intravenous doses of ch-mAb7F9 in healthy subjects by measurement of human anti-ch-mAb7F9 antibody (HACA) serum titers.
Measured: 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2012 (estimated)
- Study startApr 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Methamphetamine AbuseStudies 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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- InterveXion Therapeutics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA), University of Arkansas
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01603147
- Sponsor's protocol ID
- IXT TOA62936
- Other IDs
- R01DA031944
- Status last verified
- May 2014
- First submitted
- 18 May 2012
- Last updated
- 13 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Harris AC, LeSage MG, Shelley D, Perry JL, Pentel PR, Owens SM. The anti-(+)-methamphetamine monoclonal antibody mAb7F9 attenuates acute (+)-methamphetamine effects on intracranial self-stimulation in rats. PLoS One. 2015 Mar 5;10(3):e0118787. doi: 10.1371/journal.pone.0118787. eCollection 2015.
PubMed 25742165
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia, Double-blind, Randomized, Placebo-controlled, Ascending IV Single-dose Study to Evaluate the Safety and Pharmacokinetics of ch mAb7F9 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01603147
- Acronym / sponsor ID
- IXT TOA62936
- Conditions
- Methamphetamine Abuse
- Keywords
- methamphetamine, monoclonal antibody
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- InterveXion Therapeutics, LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA), University of Arkansas
- Study start
- Apr 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 22 May 2012 (estimated)
- 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.
The primary objective is to determine the safety and tolerability of single, ascending intravenous doses of ch-mAb7F9 in healthy subjects via physical examinations and adverse event, vital sign, electrocardiogram (ECG), and clinical laboratory testing.Phase 1a, randomized, placebo-controlled, first-in-human (FIH) study of intravenously administered ch-mAb7F9. The study will be a double-blind, dose-escalation study. Each subject will receive a single dose of ch-mAb7F9 or placebo (saline).
Detailed description
There will be 5 dose groups. At the beginning of dosing in each group, 1 subject will receive the normal saline placebo and 1 will receive the active dose. The remainder of the dose group will receive their doses beginning 48 hr later, after safety evaluations. Dosing of the remaining subjects in each dose group will occur 1 at a time, with dosing in each subsequent subject separated by a minimum of 24 hr. Subsequent dose groups will receive their doses beginning approximately 2 weeks after dosing in the preceding group, pending safety analyses.
The single doses to be administered in each cohort are 0.2, 0.6, 2, 6, and 20 mg/kg, respectively. The starting dose will be 0.2 mg/kg, and the highest dose will be 20 mg/kg (up to a maximum of 1,500 mg), which is at least 20-fold lower than the no observable adverse effect level (NOAEL) in rats to ensure subject safety.
Ch-mAb7F9 will be administered intravenously (IV) with a saline flush to clear the administration tubing of residual ch-mAb7F9. Each dose of ch-mAb7F9 will be diluted in 225 ml of saline and given over two hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline | Placebo comparator | Biological: normal salineA total of 10 subjects will receive placebo |
| ch-mAb7F9 | Experimental | Biological: ch-mAb7f9The single doses to be administered in each cohort are 0.2, 0.6, 2, 6, and 20 mg/kg, respectively. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Subject voluntarily agrees to participate in this study and signs an IRB-approved informed consent form prior to performing any of the screening procedures.
- Healthy, determined by the PI based on pre-study medical evaluation (medical history and physical examination, vital signs, ECG, and clinical laboratory evaluations).
- Males or females between 18 to 50 years of age, inclusive.
- The following applies to female subjects:
- OR
Key exclusion criteria (22 listed)
- A history of treatment with a monoclonal antibody in the past year,
- likely allergy or sensitivity to ch-mAb7F9 based on known allergies to other mAbs, or which, in the opinion of the Principal Investigator (PI), suggests an increased potential for an adverse hypersensitivity to ch-mAb7F9,
- a history of severe allergy (rash, hives, breathing difficulty, etc.) to any medications, either prescription or nonprescription, including dietary supplements or herbal medications,
- a history of allergic or environmental bronchial asthma,
- 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, or hematologic systems, or recent clinically significant surgery,
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 |
|---|---|---|
| normal salinesaline 225 ml | Biological | Saline |
| ch-mAb7f9The single doses to be administered in each cohort are 0.2, 0.6, 2, 6, and 20 mg/kg, respectively. Volume to be administered 225 ml | Biological | ch-mAb7F9 |
Primary outcome
Safety
Time frame: 21 weeks
The primary outcome is to determine the safety and tolerability of single, ascending intravenous doses of ch-mAb7F9 in healthy subjects via physical examinations and adverse event, vital sign, electrocardiogram (ECG), and clinical laboratory testing.
2 secondary outcomes
Pharmacokinetics
Time frame: 21 weeks
Immunogenicity
Time frame: 21 weeks
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 13 May 2014.
- Derived from this study: PubMed 25742165Harris AC, LeSage MG, Shelley D, Perry JL, Pentel PR, Owens SM. The anti-(+)-methamphetamine monoclonal antibody mAb7F9 attenuates acute (+)-methamphetamine effects on intracranial self-stimulation in rats. PLoS One. 2015 Mar 5;10(3):e0118787. doi: 10.1371/journal.pone.0118787. eCollection 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 normal saline and ch-mAb7f9 in people with Methamphetamine Abuse, 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 13 inclusion and 22 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 13 May 2014. 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?
Safety (time frame: 21 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01603147, which also lists 1 linked publication.
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 13 May 2014.