Major Depressive DisorderPhase 1NCT05597241
Multiple Ascending Dose and Electroencephalography Trial of GATE-202 in Healthy Volunteers
A Phase 1 study testing apimostinel in people with Major Depressive Disorder, run by Syndeio Biosciences, Inc at 1 site in United States.
Trial summary
To evaluate the safety, tolerability, pharmacokinetics and EEG pharmacodynamics of single and multiple ascending doses of apimostinel in normal human volunteers Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- apimostinel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2022to 4 Apr 2023
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is a healthy volunteer who is able to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments.
- Subject must be 18 to 55 (inclusive) years of age, at the time of signing the informed consent.
- Subject has a BMI between 18.5 kg/m2 and 30 kg/m2 (inclusive), with a minimum body weight of 50 kg.
- Subject is male or female.
- Females are eligible to participate if not pregnant, not breastfeeding, and at least one of the following conditions applies:
- Surgically sterile or at least 2 years menopausal, confirmed by follicle-stimulating hormone (FSH) at Screening, or,
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- If women of childbearing potential (WOCBP), subject must use an acceptable method of birth control from date of Screening to at least 30 days after the last dose of study intervention and must have a documented negative blood or urine pregnancy test within 24 hours prior to dosing (SAD cohort) or within 48 hours prior to dosing (MAD cohorts). If reported sterile or postmenopausal, will be confirmed by FSH.
- Male subject must meet one of the following:
- Surgically sterile
- If not surgically sterile, then use of an acceptable form of contraception as detailed in Appendix 4 from the time of randomization through 28 days following the last dose of study intervention. Male subjects or male partners of female subjects are recommended to not donate sperm from Screening (Visit 1) until 28 calendar days after the last dose of study intervention. Male subjects are strongly advised to inform female partners of the need for them to use acceptable birth control methods during this time period.
- Clinical laboratory values <2 times the upper limit of normal or deemed not clinically significant by the Investigator at Screening and Admission Day.
Who cannot join
- Type I or Type II diabetes mellitus.
- Malignancy in the last 5 years, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
- History of allergy or sensitivity, or intolerance to N-methyl-D-aspartate (NMDA) receptor ligands including ketamine, dextromethorphan, memantine, methadone, dextropropoxyphene, or ketobemidone.
- Psychiatric disease including major depressive disorder, bipolar disorder, anxiety, or schizophrenia, or other medical condition that, in the opinion of the Investigator, would interfere with the evaluation of study intervention safety.
- Any personal or family history of seizure (including febrile seizures) or diagnosis of epilepsy or episode of unexplained loss of consciousness.
- Any history of neurological or other medical conditions which in the opinion of the Investigator has the potential to reduce seizure threshold, e.g., history of head concussion, traumatic brain injury, taking any medications that may reduce seizure threshold, developmental abnormalities in the brain, or metabolic causes, including electrolyte abnormalities such as hyponatremia.
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- Subject has a history of excessive bleeding after invasive procedures or surgery or known coagulation or platelet abnormality or has been on any blood thinner or medication affecting platelet function, such as aspirin, nonsteroidal antiinflammatory medications, corticosteroids (except topical) or warfarin within the 7 days prior to enrollment or has known allergy to any anesthetic agent that may be used for the lumbar catheterization.
- Subject has a history of infection that required IV antibiotics within the 45 days or oral antibiotics within 30 days prior to enrollment, and, at the time of clinic admission, be febrile or have signs/symptoms consistent with an infection.
- Subject has a history of or physical examination evidence of a lumbar spine abnormality that may preclude placement of a spinal catheter, presence of intraspinal shunt devices (e.g., ventriculoperitoneal shunt), or history of elevated intracranial pressure, normal pressure hydrocephalus, or other neurological condition that in the opinion of the Investigator precludes safe study participation. A lumbar X-ray that excludes spine abnormalities must have been taken within the past 12 months and made available or the subject must agree to have one taken as part of the qualification.
- In the opinion of the Investigator, the Safety Monitor, or the Sponsor Study Monitor, has a history of severe renal or hepatic impairment, severe active hepatic disease, or other clinically significant medical condition that may preclude safe study participation.
- Subject who has clinical signs and symptoms consistent with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); e.g., fever, dry cough, dyspnea, sore throat, fatigue, or positive SARS-CoV-2 test result within 14 days prior to the Screening Visit or at admission.
- Subject who had a severe course of SARS-CoV-2 (extracorporeal membrane oxygenation, mechanically ventilated).
- Currently taking prescription or over-the-counter medications including herbal therapies, within 14 days of enrollment into the study.
- Received another investigational drug or device within 30 days or 5 half-lives, whichever is longer prior to enrollment in this study (defined as the time of admission; Day -2 for MAD and Day -1 for SAD).
- Previously randomized in this study.
- Has a positive test for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, or human immunodeficiency virus (HIV) at Screening or has been previously treated for hepatitis B, hepatitis C, or HIV infection.
- For Cohorts 2-5, evidence of hearing loss that cannot be compensated for in the event related potential (ERP) tests, assessed by audiologic examination.
- Evidence of alcohol abuse, defined as regular consumption of alcohol within 6 months prior to screening defined as > 7 drinks/week for females and > 14 drinks/week for males where 1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor. Use of illicit substances and recreational drug use (such as marijuana) within 3 months prior to the Screening Visit is also prohibited.
- Current abuse of illicit substances, using the Diagnostic and Statistical Manual V definition of substance use disorder.
- Has a positive urine screen for drugs of abuse (see Table 10 1) at Screening and admission day (Day -2 for MAD and Day -1 for SAD).
- Currently pregnant, planning to become pregnant during the course of the study, or nursing mother.
- At Screening, if the Columbia-Suicide Severity Rating Scale (C-SSRS) responses ("yes" answers to item 4 or 5) indicate that the subject may have experienced suicidal ideation associated with actual intent or plan within 12 months of Screening, may have had a history of suicidal behavior within the past 10 years, or had any lifetime history of recurrent suicidal behavior, the subject will be excluded from participation in the study.
- Previous cerebrospinal fluid (CSF) collection within 30 days prior to admission to the clinical research unit.
- Impaired function (glomerular filtration rate <60 mL/min) by the chronic kidney disease-Epidemiological Collaboration (CKD-EPI Creatinine) calculation method. Can be repeated once during Screening and once during admission.
- Elevated systolic blood pressure (>140 mmHg) or diastolic blood pressure (>90 mmHg) and/or increased corrected QT interval (QTc) (>450 msec for men or >470 msec for women) or additional risk factors for Torsades de Pointes including heart failure, hypokalemia, or family history of Long QT Syndrome at Screening or Admission Day. Can be repeated once during Screening and once during admission.
- Has donated blood (≥500 mL) or blood products within 6 weeks (42 days) prior to admission.
- Subject is deaf or has hearing loss of more than 25 decibels (dB) in one or both ears.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Dose and Multiple Ascending Dose, Single Center Phase1 Study of Safety, Tolerability, Pharmacokinetics, and Electroencephalography of Intravenous GATE-202 in Healthy Volunteers
To evaluate the safety, tolerability, pharmacokinetics and EEG pharmacodynamics of single and multiple ascending doses of apimostinel in normal human volunteers
Read the detailed description
Single ascending dose (SAD), multiple ascending dose (MAD), double-blind placebo-controlled study in normal human volunteers.
Subjects will receive a single 25 mg IV dose of apimostinel or matching placebo, or 8 consecutive days of 1, 5, 10, or 25 mg IV or matching placebo.
- Conditions
- Major Depressive Disorder
- Being tested
- apimostinel, Placebo
- Keywords
- major depressive disorder, single ascending dose, multiple ascending dose, pharmacokinetics, EEG
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apimostinelDrug
Also called GATE-202
N-methyl-D-aspartate (NMDA) receptor modulator
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1, Apimostinel | Experimental | Apimostinel, 25 mg IV single dose Receives: Drug: apimostinel |
| Cohort 1, Placebo | Placebo comparator | Placebo, IV single Dose Receives: Drug: Placebo |
| Cohort 2, Apimostinel, 1 mg IV 8 consecutive daily doses | Experimental | Apimostinel, 1 mg IV 8 consecutive daily doses Receives: Drug: apimostinel |
| Cohort 2, Placebo IV 8 consecutive daily doses | Placebo comparator | Placebo IV 8 consecutive daily doses Receives: Drug: Placebo |
| Cohort 3, Apimostinel, 5 mg IV 8 consecutive daily doses | Experimental | Apimostinel, 5 mg IV 8 consecutive daily doses Receives: Drug: apimostinel |
| Cohort 3, Placebo 8 consecutive daily doses | Placebo comparator | Placebo IV 8 consecutive daily doses Receives: Drug: Placebo |
| Cohort 4, Apimostinel, 10 mg IV 8 consecutive daily doses | Experimental | Apimostinel, 10 mg IV 8 consecutive daily doses Receives: Drug: apimostinel |
| Cohort 4, Placebo 8 consecutive daily doses | Placebo comparator | Placebo IV 8 consecutive daily doses Receives: Drug: Placebo |
| Cohort 5, Apimostinel, 25 mg IV, 8 consecutive daily doses | Experimental | Apimostinel, 25 mg IV 8 consecutive daily doses Receives: Drug: apimostinel |
| Cohort 5, Placebo IV 8 consecutive daily doses | Placebo comparator | Placebo IV 8 consecutive daily doses Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Emergent Adverse Events
Number of Participants with Treatment-Emergent Adverse Events Through Study Completion
Measured: 36 days
Secondary outcomes (1)
Pharmacokinetics - Maximum Plasma Concentration
Maximum observed plasma concentration after a single dose or after 8 doses
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start15 Oct 2022
- Primary completion4 Apr 2023
- Study completion4 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syndeio Biosciences, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ronald M Burch, MD PhD, Principal investigator, Syndeio Biosciences, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05597241
- Sponsor's protocol ID
- GATE-202-C-101
- Status last verified
- Oct 2022
- First submitted
- 21 Oct 2022
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single Dose and Multiple Ascending Dose, Single Center Phase1 Study of Safety, Tolerability, Pharmacokinetics, and Electroencephalography of Intravenous GATE-202 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05597241
- Acronym / sponsor ID
- GATE-202-C-101
- Conditions
- Major Depressive Disorder
- Keywords
- major depressive disorder, single ascending dose, multiple ascending dose, pharmacokinetics, EEG
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Syndeio Biosciences, IncIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 4 Apr 2023 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 28 Oct 2022 (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.
To evaluate the safety, tolerability, pharmacokinetics and EEG pharmacodynamics of single and multiple ascending doses of apimostinel in normal human volunteers
Detailed description
Single ascending dose (SAD), multiple ascending dose (MAD), double-blind placebo-controlled study in normal human volunteers.
Subjects will receive a single 25 mg IV dose of apimostinel or matching placebo, or 8 consecutive days of 1, 5, 10, or 25 mg IV or matching placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Cohort 1, Apimostinel | Experimental | Drug: apimostinelApimostinel, 25 mg IV single dose |
| Cohort 1, Placebo | Placebo comparator | Drug: PlaceboPlacebo, IV single Dose |
| Cohort 2, Apimostinel, 1 mg IV 8 consecutive daily doses | Experimental | Drug: apimostinelApimostinel, 1 mg IV 8 consecutive daily doses |
| Cohort 2, Placebo IV 8 consecutive daily doses | Placebo comparator | Drug: PlaceboPlacebo IV 8 consecutive daily doses |
| Cohort 3, Apimostinel, 5 mg IV 8 consecutive daily doses | Experimental | Drug: apimostinelApimostinel, 5 mg IV 8 consecutive daily doses |
| Cohort 3, Placebo 8 consecutive daily doses | Placebo comparator | Drug: PlaceboPlacebo IV 8 consecutive daily doses |
| Cohort 4, Apimostinel, 10 mg IV 8 consecutive daily doses | Experimental | Drug: apimostinelApimostinel, 10 mg IV 8 consecutive daily doses |
| Cohort 4, Placebo 8 consecutive daily doses | Placebo comparator | Drug: PlaceboPlacebo IV 8 consecutive daily doses |
| Cohort 5, Apimostinel, 25 mg IV, 8 consecutive daily doses | Experimental | Drug: apimostinelApimostinel, 25 mg IV 8 consecutive daily doses |
| Cohort 5, Placebo IV 8 consecutive daily doses | Placebo comparator | Drug: PlaceboPlacebo IV 8 consecutive daily doses |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Subject is a healthy volunteer who is able to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments.
- Subject must be 18 to 55 (inclusive) years of age, at the time of signing the informed consent.
- Subject has a BMI between 18.5 kg/m2 and 30 kg/m2 (inclusive), with a minimum body weight of 50 kg.
- Subject is male or female.
- Females are eligible to participate if not pregnant, not breastfeeding, and at least one of the following conditions applies:
Key exclusion criteria (27 listed)
- Type I or Type II diabetes mellitus.
- Malignancy in the last 5 years, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
- History of allergy or sensitivity, or intolerance to N-methyl-D-aspartate (NMDA) receptor ligands including ketamine, dextromethorphan, memantine, methadone, dextropropoxyphene, or ketobemidone.
- Psychiatric disease including major depressive disorder, bipolar disorder, anxiety, or schizophrenia, or other medical condition that, in the opinion of the Investigator, would interfere with the evaluation of study intervention safety.
- Any personal or family history of seizure (including febrile seizures) or diagnosis of epilepsy or episode of unexplained loss of consciousness.
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 |
|---|---|---|
| apimostinelAlso: GATE-202N-methyl-D-aspartate (NMDA) receptor modulator | Drug | Cohort 1, Apimostinel, Cohort 2, Apimostinel, 1 mg IV 8 consecutive daily doses, Cohort 3, Apimostinel, 5 mg IV 8 consecutive daily doses, Cohort 4, Apimostinel, 10 mg IV 8 consecutive daily doses, Cohort 5, Apimostinel, 25 mg IV, 8 consecutive daily doses |
| PlaceboPlacebo | Drug | Cohort 1, Placebo, Cohort 2, Placebo IV 8 consecutive daily doses, Cohort 3, Placebo 8 consecutive daily doses, Cohort 4, Placebo 8 consecutive daily doses, Cohort 5, Placebo IV 8 consecutive daily doses |
Primary outcome
Treatment Emergent Adverse Events
Time frame: 36 days
Number of Participants with Treatment-Emergent Adverse Events Through Study Completion
1 secondary outcome
Pharmacokinetics - Maximum Plasma Concentration
Time frame: 72 hours
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 11 Apr 2023.
- 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.
Ronald M Burch, MD PhD principal investigator
Syndeio Biosciences, Inc
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 apimostinel in people with Major Depressive Disorder, run by Syndeio Biosciences, 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?
The sponsor lists 11 inclusion and 27 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 11 Apr 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?
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 (time frame: 36 days). 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 11 Apr 2023.