MDDPhase 1NCT05528315
SAD/MAD of ABX-002-1902 Investigating the Safety, Pharmacokinetics/Pharmacodynamics of in Healthy Subjects
A Phase 1 study testing ABX-002 in people with MDD, run by Autobahn Therapeutics, Inc. at 1 site in Australia.
Trial summary
The study will evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single-ascending doses (SAD) and multiple ascending doses (MAD) of ABX-002 in healthy volunteers (HV) Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- MDD
- What is being tested?
- ABX-002
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteAustralia
- Study dates
- 12 Oct 2022to 13 Sep 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
- In good health, based on medical history, physical examination (including neurological examination), vital sign measurements, and laboratory safety tests
- Body mass index (BMI) 18-32 kg/m2 (inclusive)
- No clinically significant abnormality on ECG
- Must be a nonsmoker or a social smoker
- In agreement to eat a protocol-specified meal
- Women of childbearing potential (WOCBP) must have a negative urine pregnancy test at the time of the Screening Visit and before the first administration of the study drug
- WOCBP and all male subjects who are sexually active must practice effective contraception during the study and be willing and able to continue contraception for at least 90 days after their last dose of study treatment
Who cannot join
- History of any illness that, in the opinion of the study Investigator, might confound the results of the study or pose an additional risk to the subject by virtue of their participation in the study
- Mentally or legally incapacitated, has significant emotional problems
- Historical risk of suicide or according to the Investigator's clinical judgement, has made a suicide attempt in the previous 6 months, or has a history of deliberate self-harm in the past 6 months
- History of clinically significant endocrine, psychiatric, gastrointestinal, cardiovascular, peripheral vascular, neurological, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases in medical history or upon physical examination.
- History of known pre-existing liver disorders (eg, nonalcoholic fatty liver disease) and unstable liver disease History of clinically significant neoplastic disease, with the exception of adequately treated localized or in situ nonmelanoma carcinoma of the skin (ie, basal cell carcinoma) or of the cervix
- History or evidence of any of the following: myocardial infarction; cardiac valvulopathy; cardiac surgery revascularization (coronary artery bypass grafting or percutaneous transluminal coronary angioplasty); unstable angina; cerebrovascular accident, stroke, or transient ischemic attack; pacemaker; atrial fibrillation, flutter, or nonsustained or sustained ventricular tachycardia (VT); pulmonary arterial hypertension; sick sinus syndrome, second- or third-degree atrioventricular (AV) block; uncontrolled hypertension; congestive heart failure; personal or family history of sudden death or long QT syndrome; unexplained syncope or syncope within the last 3 years regardless of etiology; or history of hypokalemia
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- Mean systolic blood pressure (BP) > 140 mm Hg or mean diastolic BP > 90 mm Hg
- History of multiple significant allergies and/or severe allergies (eg, food, drug, latex allergy) or has had an anaphylactic reaction or significant intolerability to prescription drugs, nonprescription drugs, or food
- Major surgery or an invasive procedure performed ≤ 3 months prior to the Screening Visit. Has donated or lost 1 unit (approximately 500 mL) of blood ≤ 56 days prior to the Screening Visit or intends to donate blood or blood products during the course of the study
- Recently received an influenza or Coronavirus Disease 2019 (COVID-19) vaccination < 1 week prior to Day -2 or intends to have an influenza or COVID-19 vaccination during the course of the study
- Subjects who are pregnant or breastfeeding
- Personal history of epilepsy or familial history of epilepsy as documented by medical records or by the history provided to the Investigator by the subject
- History of febrile seizures or seizures related to medication, intoxication, or withdrawal
- History of cataract of the lens as documented by medical records or by the history provided to the Investigator by the subject
- History of neurological abnormalities such as brain injury including traumatic injury, perinatal cerebropathy and postnatal brain damage, blood brain barrier abnormality, or cavernous angioma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of ABX-002 in Healthy Adult Subjects
The study will evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single-ascending doses (SAD) and multiple ascending doses (MAD) of ABX-002 in healthy volunteers (HV)
Read the detailed description
The study will evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single-ascending doses (SAD) and multiple ascending doses (MAD) of ABX-002 in healthy volunteers (HV) to identify repeated dose levels that are safe and well-tolerated.
- Conditions
- MDD
- Being tested
- ABX-002, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABX-002Drug
Also called Methyl amide prodrug
ABX-002
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Single dose, ABX-002 | Experimental | Single Dose (solution) dose escalating Receives: Drug: ABX-002; Drug: Placebo |
| Multiple dose, ABX-002 | Experimental | Multiple Dose (solution) dose escalating Receives: Drug: ABX-002; Drug: Placebo |
| Formulation Comparison Solution or Capsule | Experimental | ABX-002 Single Dose TBD - Solution ABX-002 Single Dose TBD - Capsule Receives: Drug: ABX-002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of ABX-002 in healthy subjects as assessed by incidence of treatment-emergent AEs (TEAEs) and SAEs
Safety will be assessed by AEs, laboratory assessments (eg, hematology, coagulation, blood chemistry, THA markers, bone turnover biomarkers, cardiac and muscle markers, SHBG), urinalysis, pregnancy tests, vital signs (supine, orthostatic), analysis of safety ECGs, incidence and duration of selected cardiac rhythms on Holter monitoring, presence of drug-related excessive slowing or EA on EEG, slit lamp examination of the lens for cataract, and physical and neurological examinations
Measured: Change from baseline
Secondary outcomes (4)
Pharmacokinetics of ABX-002 in health subjects as assessed by maximum plasma concentration (Cmax) towards determination of the optimal PK dose
Determination of maximum plasma concentration (Cmax)
Measured: Day 1 to Day 5
Pharmacokinetics of ABX-002 in health subjects as assessed by time to maximum concentration (Tmax) towards determination of the optimal PK dose
Determination of time to maximum concentration
Measured: Day 1 to Day 5
Pharmacokinetics of ABX-002 in health subjects as assessed in healthy subjects as assessed by plasma exposure (AUC0-t, AUC0-inf) determination of the optimal pharmacokinetic dose
Determination of plasma exposure (AUC0-t, AUC0-inf)
Measured: Day 1 to Day 5
Pharmacokinetics of ABX-002 in healthy subjects as assessed by terminal elimination half life (t1/2) determination of the optimal pharmacokinetic dose
Determination of terminal half life
Measured: Day 1 to Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start12 Oct 2022
- Primary completion26 Jun 2023
- Study completion13 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MDDStudies 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
- Double-Blind, Randomized, Placebo-Controlled Single and Multiple Ascending Doses in Healthy Adult Subjects
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Autobahn Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Responsible party
- Sponsor
- Investigators
- Gudarz Davar, MD, Study chair, Autobahn Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528315
- Sponsor's protocol ID
- ABX-002-1902
- Status last verified
- Sep 2023
- First submitted
- 19 Aug 2022
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 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 and Multiple Ascending Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of ABX-002 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05528315
- Acronym / sponsor ID
- ABX-002-1902
- Conditions
- MDD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Autobahn Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 26 Jun 2023 (actual)
- Study completion
- 13 Sep 2023 (actual)
- First posted
- 6 Sep 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.
The study will evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single-ascending doses (SAD) and multiple ascending doses (MAD) of ABX-002 in healthy volunteers (HV)
Detailed description
The study will evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single-ascending doses (SAD) and multiple ascending doses (MAD) of ABX-002 in healthy volunteers (HV) to identify repeated dose levels that are safe and well-tolerated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Double-Blind, Randomized, Placebo-Controlled Single and Multiple Ascending Doses in Healthy Adult Subjects
| Arm | Type | Receives |
|---|---|---|
| Single dose, ABX-002 | Experimental | Drug: ABX-002, Drug: PlaceboSingle Dose (solution) dose escalating |
| Multiple dose, ABX-002 | Experimental | Drug: ABX-002, Drug: PlaceboMultiple Dose (solution) dose escalating |
| Formulation Comparison Solution or Capsule | Experimental | Drug: ABX-002ABX-002 Single Dose TBD - Solution ABX-002 Single Dose TBD - Capsule |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- In good health, based on medical history, physical examination (including neurological examination), vital sign measurements, and laboratory safety tests
- Body mass index (BMI) 18-32 kg/m2 (inclusive)
- No clinically significant abnormality on ECG
- Must be a nonsmoker or a social smoker
- In agreement to eat a protocol-specified meal
Key exclusion criteria (15 listed)
- History of any illness that, in the opinion of the study Investigator, might confound the results of the study or pose an additional risk to the subject by virtue of their participation in the study
- Mentally or legally incapacitated, has significant emotional problems
- Historical risk of suicide or according to the Investigator's clinical judgement, has made a suicide attempt in the previous 6 months, or has a history of deliberate self-harm in the past 6 months
- History of clinically significant endocrine, psychiatric, gastrointestinal, cardiovascular, peripheral vascular, neurological, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases in medical history or upon physical examination.
- History of known pre-existing liver disorders (eg, nonalcoholic fatty liver disease) and unstable liver disease History of clinically significant neoplastic disease, with the exception of adequately treated localized or in situ nonmelanoma carcinoma of the skin (ie, basal cell carcinoma) or of the cervix
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 |
|---|---|---|
| ABX-002Also: Methyl amide prodrugABX-002 | Drug | Formulation Comparison Solution or Capsule, Multiple dose, ABX-002, Single dose, ABX-002 |
| PlaceboPlacebo | Drug | Multiple dose, ABX-002, Single dose, ABX-002 |
Primary outcome
Safety and tolerability of ABX-002 in healthy subjects as assessed by incidence of treatment-emergent AEs (TEAEs) and SAEs
Time frame: Change from baseline
Safety will be assessed by AEs, laboratory assessments (eg, hematology, coagulation, blood chemistry, THA markers, bone turnover biomarkers, cardiac and muscle markers, SHBG), urinalysis, pregnancy tests, vital signs (supine, orthostatic), analysis of safety ECGs, incidence and duration of selected cardiac rhythms on Holter monitoring, presence of drug-related excessive slowing or EA on EEG, slit lamp examination of the lens for cataract, and physical and neurological examinations
4 secondary outcomes
Pharmacokinetics of ABX-002 in health subjects as assessed by maximum plasma concentration (Cmax) towards determination of the optimal PK dose
Time frame: Day 1 to Day 5
Pharmacokinetics of ABX-002 in health subjects as assessed by time to maximum concentration (Tmax) towards determination of the optimal PK dose
Time frame: Day 1 to Day 5
Pharmacokinetics of ABX-002 in health subjects as assessed in healthy subjects as assessed by plasma exposure (AUC0-t, AUC0-inf) determination of the optimal pharmacokinetic dose
Time frame: Day 1 to Day 5
Pharmacokinetics of ABX-002 in healthy subjects as assessed by terminal elimination half life (t1/2) determination of the optimal pharmacokinetic dose
Time frame: Day 1 to Day 5
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 15 Sep 2023.
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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.
Gudarz Davar, MD study chair
Autobahn Therapeutics, 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 ABX-002 in people with MDD, run by Autobahn Therapeutics, Inc. at 1 site in Australia.
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 7 inclusion and 15 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 15 Sep 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 Australia. 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. 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 and tolerability of ABX-002 in healthy subjects as assessed by incidence of treatment-emergent AEs (TEAEs) and SAEs (time frame: Change from baseline). 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 15 Sep 2023.