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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05528315




Registration number
NCT05528315
Ethics application status
Date submitted
19/08/2022
Date registered
6/09/2022
Date last updated
15/09/2023

Titles & IDs
Public title
SAD/MAD of ABX-002-1902 Investigating the Safety, Pharmacokinetics/Pharmacodynamics of in Healthy Subjects
Scientific 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
Secondary ID [1] 0 0
ABX-002-1902
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
MDD 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABX-002
Treatment: Drugs - Placebo

Experimental: Single dose, ABX-002 - Single Dose (solution) dose escalating

Experimental: Multiple dose, ABX-002 - Multiple Dose (solution) dose escalating

Experimental: Formulation Comparison Solution or Capsule - ABX-002 Single Dose TBD - Solution ABX-002 Single Dose TBD - Capsule


Treatment: Drugs: ABX-002
ABX-002

Treatment: Drugs: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability of ABX-002 in healthy subjects as assessed by incidence of treatment-emergent AEs (TEAEs) and SAEs
Timepoint [1] 0 0
Change from baseline
Secondary outcome [1] 0 0
Pharmacokinetics of ABX-002 in health subjects as assessed by maximum plasma concentration (Cmax) towards determination of the optimal PK dose
Timepoint [1] 0 0
Day 1 to Day 5
Secondary outcome [2] 0 0
Pharmacokinetics of ABX-002 in health subjects as assessed by time to maximum concentration (Tmax) towards determination of the optimal PK dose
Timepoint [2] 0 0
Day 1 to Day 5
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Day 1 to Day 5
Secondary outcome [4] 0 0
Pharmacokinetics of ABX-002 in healthy subjects as assessed by terminal elimination half life (t1/2) determination of the optimal pharmacokinetic dose
Timepoint [4] 0 0
Day 1 to Day 5

Eligibility
Key inclusion criteria
- 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
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- 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

- 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/09/2023
Sample size
Target
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Autobahn Therapeutics, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Novotech (Australia) Pty Limited
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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)
Trial website
https://clinicaltrials.gov/ct2/show/NCT05528315
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gudarz Davar, MD
Address 0 0
Autobahn Therapeutics, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries